ClinicalTrials.gg
CompletedNCT07905612Updated Oct 29, 2026

Singing Therapy for Rehabilitating Facial Mimicry in Parkinson's Disease: A Randomised Controlled Trial

An interventional study of Singing Imitation Therapy and Singing Observation Therapy in PARKINSON DISEASE (Disorder), sponsored by Toronto Metropolitan University. Completed at 1 site in Canada. Open to participants aged 50 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-29.

Sponsored by Toronto Metropolitan University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 13 years 3 months after the study started (first participant enrolled Jun 2013, registered Oct 2026).
Updated Oct 29, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
50 Years to 75 Years
Sex
All
01

Study summary

Parkinson's disease can reduce facial expression and change the voice, making it harder to communicate emotions. This study examined whether practising facial and vocal imitation through speech and singing could improve facial expression and emotional communication in people with Parkinson's disease.

Participants were assigned by chance to one of two 13-week programs. In Singing Imitation Therapy, participants watched and listened to recordings of emotional speech and song and copied the facial and vocal expressions. In Singing Observation Therapy, participants watched and listened to the recordings without being instructed to copy them.

The main hypothesis was that imitation would lead to greater improvements in facial expression and automatic facial responses to other people's emotional expressions than observation alone.

Read the detailed description

Reduced spontaneous facial expression, or hypomimia, can affect emotional communication and social interaction in Parkinson's disease. Facial mimicry refers to subtle, automatic facial muscle responses that occur when observing another person's emotional expressions. The study investigated whether deliberate practice of emotional facial and vocal expression could improve this spontaneous responsiveness.

The intervention was based on the proposed relationship between perceiving emotional expressions and producing the associated facial and vocal movements. Repeated intentional imitation was hypothesized to strengthen facial motor responsiveness and support expressive function. The observation comparator was included to examine whether active imitation offered additional benefits beyond repeated exposure to emotional speech and song. The broader rationale was that improved expressive function might support emotional communication and well-being.

Additional audio and video recordings were collected for exploratory analyses of vocal production, facial movement, and facial-vocal coordination. Vocal assessments using LSVT assessment tasks were recorded at Week 1, Week 13, and two months after treatment completion. Therapy sessions were video-recorded weekly during Weeks 1-13.

The original protocol proposed exploratory analyses of vocal frequency and intensity, including their ranges; speech rate; voice perturbation measures, including jitter and shimmer; formant frequencies; and harmonics-to-noise ratio. Planned facial movement analyses included displacement, velocity, and acceleration, together with analyses of coordination between facial movement and vocal acoustics.

Further analysis of instructed facial imitation is proposed within the Singing Imitation Therapy group because the treatment groups performed different activities during therapy. These analyses would characterise imitation performance and changes within that group over time. Additional features and computational methods selected after trial completion will be distinguished from those specified in the original protocol.

The trial was completed before public registration. It was retrospectively registered on the Open Science Framework (OSF) on May 25, 2026. The OSF record documents the study design and a later plan for longitudinal treatment-effect analyses comparing Singing Imitation Therapy with Singing Observation Therapy. The present ClinicalTrials.gov record provides an additional retrospective registration of the same completed trial.

02

Conditions studied

  • PARKINSON DISEASE (Disorder)

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Keywords

  • singing therapy
  • facial bradykinesia
  • motor rehabilitation
  • Parkinson's disease
03

In context

Parkinson Disease

4,595 studies on the registry are indexed under Parkinson Disease; 1,099 are open to participants now.

This study's enrollment of 48 is above the median of 40 across 3,375 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Toronto Metropolitan University is the lead sponsor of 63 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Participants with Parkinson's disease:

  • Clinical diagnosis of idiopathic Parkinson's disease.
  • Aged 50-75 years at enrolment.
  • Parkinson's disease diagnosed at age 50 years or older.
  • At least eight years of English-speaking experience.
  • Provided written informed consent.

Caregiver participants:

  • Informal caregiver of a participant enrolled in the Parkinson's disease treatment trial.
  • Provided separate informed consent to participate in questionnaire assessments.

No separate age eligibility criteria were specified for caregiver participants. The stated age range of 50-75 years applies only to participants with Parkinson's disease.

Exclusion criteria

Exclusion Criteria:

  • Secondary or acquired parkinsonism.
  • Hoehn and Yahr stage greater than 4.
  • Clinically significant depressive symptoms, defined as a Beck Depression Inventory (BDI) score greater than 19.
  • Cognitive impairment, defined for screening as a Montreal Cognitive Assessment (MoCA) score below 21.
  • Severe visual or auditory deficits.
  • Concurrent participation in another treatment trial.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    Singing Imitation Therapy

    Participants received Singing Imitation Therapy, involving active imitation of emotional facial and vocal expressions presented in speech and song videos.

    Behavioral: Singing Imitation Therapy

  • Active comparator
    Singing Observation Therapy

    Participants received Singing Observation Therapy, involving observation of emotional speech and song videos without instructed facial or vocal imitation.

    Behavioral: Singing Observation Therapy

Interventions

  • BehavioralSinging Imitation Therapy

    Participants received approximately 20-minute, therapist-delivered home sessions once weekly for 13 weeks. Sessions used 43-45 emotional speech and song videos, with metronome-supported song presented before speech. Each video was presented twice: participants observed the first presentation and synchronously imitated the actor's facial and vocal expression during the second. After each sequence, participants identified the emotion and rated its intensity on a 1-5 scale. Therapist feedback encouraged facial and vocal expressiveness. Participants received DVDs of song-with-metronome videos for weekly home practice using the same imitation instructions; practice completion was not formally monitored.

  • BehavioralSinging Observation Therapy

    Participants received approximately 20-minute, therapist-delivered home sessions once weekly for 13 weeks, matched to the imitation intervention in structure and duration. Sessions used 43-45 emotional speech and song videos, with metronome-supported song presented before speech. Each video was presented twice. Participants watched and listened without instructed imitation, attending to the actor's facial and vocal emotion and its intensity. After each sequence, participants identified the emotion and rated its intensity on a 1-5 scale. Therapist feedback directed attention to the actor's voice or facial expression. Participants received DVDs of song-with-metronome videos for weekly home practice using the same observation instructions; practice completion was not formally monitored.

06

What researchers measure

Primary outcomes

  1. Change in Standardized Facial Muscle Activity From Week 1 to Week 13

    Change in standardized facial muscle activity from Week 1 to Week 13. Surface electromyography is recorded from the zygomaticus major, corrugator supercilii, and medial frontalis during emotional speech and song observation. Mean activity 1-4 seconds after stimulus onset is expressed as percentage change from a 2-second prestimulus baseline, then standardized within participant and muscle, then within participant across muscles. Both recordings at each visit are included. Activity is retained by muscle and stimulus emotion. Analyses assess overall responsiveness across emotional trials, excluding neutral/calm, and emotion-congruent responses: happy versus neutral/calm for zygomaticus; negative emotions (sad, angry, fearful, disgust) versus neutral/calm for corrugator; and surprise versus neutral/calm for frontalis. Values are unitless with no fixed limits; positive changes indicate increased activity.

    Time frame: Week 1 and Week 13 (end of treatment).

  2. Change in Standardized Facial Muscle Activity From Week 1 to Two Months After Treatment

    Change in standardized facial muscle activity from Week 1 to two months after treatment completion. Surface electromyography is recorded from the zygomaticus major, corrugator supercilii, and medial frontalis during emotional speech and song observation. Mean activity 1-4 seconds after stimulus onset is expressed as percentage change from a 2-second prestimulus baseline, then standardized within participant and muscle, then within participant across muscles. Both recordings at each visit are included. Activity is retained by muscle and stimulus emotion. Analyses assess overall responsiveness across emotional trials, excluding neutral/calm, and emotion-congruent responses: happy versus neutral/calm for zygomaticus; negative emotions (sad, angry, fearful, disgust) versus neutral/calm for corrugator; and surprise versus neutral/calm for frontalis. Values are unitless with no fixed limits; positive changes indicate increased activity.

    Time frame: Week 1 and two months after completion of the 13-week intervention.

  3. Change in Modified MDS-UPDRS Part III Motor Examination Total Score From Week 1 to Week 13

    Change from Week 1 to Week 13, calculated as the Week 13 value minus the Week 1 value. Motor impairment is assessed using Part III of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS). The postural-stability item was not administered. The modified total comprises the remaining 32 ratings, each scored 0-4; eligible partially completed assessments are prorated to the 32-rating scale. Total scores range from 0 to 128, with higher scores indicating greater impairment. Change scores range from -128 to 128. Negative changes indicate reduced motor impairment.

    Time frame: Week 1 and Week 13 (end of treatment).

  4. Change in Modified MDS-UPDRS Part III Motor Examination Total Score From Week 1 to Two Months After Treatment

    Change from Week 1 to two months after treatment completion, calculated as the follow-up value minus the Week 1 value. Motor impairment is assessed using Part III of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS). The postural-stability item was not administered. The modified total comprises the remaining 32 ratings, each scored 0-4; eligible partially completed assessments are prorated to the 32-rating scale. Total scores range from 0 to 128, with higher scores indicating greater impairment. Change scores range from -128 to 128. Negative changes indicate reduced motor impairment.

    Time frame: Week 1 and two months after completion of the 13-week intervention.

  5. Change in MDS-UPDRS Part III Facial Expression Score From Week 1 to Week 13

    Change from Week 1 to Week 13, calculated as the Week 13 value minus the Week 1 value. Facial expression is assessed using item 3.2 of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part III. This clinician-rated item assesses reduced facial expression, including blinking, spontaneous smiling, and lower-face movement. Scores range from 0 to 4, with higher scores indicating greater impairment. Change scores range from -4 to 4. Negative changes indicate reduced facial-expression impairment.

    Time frame: Week 1 and Week 13 (end of treatment).

  6. Change in MDS-UPDRS Part III Facial Expression Score From Week 1 to Two Months After Treatment

    Change from Week 1 to two months after treatment completion, calculated as the follow-up value minus the Week 1 value. Facial expression is assessed using item 3.2 of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part III. This clinician-rated item assesses reduced facial expression, including blinking, spontaneous smiling, and lower-face movement. Scores range from 0 to 4, with higher scores indicating greater impairment. Change scores range from -4 to 4. Negative changes indicate reduced facial-expression impairment.

    Time frame: Week 1 and two months after completion of the 13-week intervention.

  7. Change in MDS-UPDRS Part III Speech Score From Week 1 to Week 13

    Change from Week 1 to Week 13, calculated as the Week 13 value minus the Week 1 value. Speech is assessed using item 3.1 of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part III. This clinician-rated item assesses speech volume, modulation, and clarity. Scores range from 0 to 4, with higher scores indicating greater speech impairment. Change scores range from -4 to 4. Negative changes indicate reduced speech impairment.

    Time frame: Week 1 and Week 13 (end of treatment).

  8. Change in MDS-UPDRS Part III Speech Score From Week 1 to Two Months After Treatment

    Change from Week 1 to two months after treatment completion, calculated as the follow-up value minus the Week 1 value. Speech is assessed using item 3.1 of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part III. This clinician-rated item assesses speech volume, modulation, and clarity. Scores range from 0 to 4, with higher scores indicating greater speech impairment. Change scores range from -4 to 4. Negative changes indicate reduced speech impairment.

    Time frame: Week 1 and two months after completion of the 13-week intervention.

Secondary outcomes

  1. Emotion-Recognition Accuracy at Week 13

    Emotion recognition is assessed during the audiovisual speech and song task. After each video, participants select the emotion portrayed. Neutral and calm are combined into a single category for both target emotions and participant responses before scoring. Each valid response is scored 1 if it matches the target category after this grouping and 0 otherwise. Accuracy is expressed as the percentage of correct responses, from 0% to 100%, with higher values indicating more accurate recognition. Responses from both recordings at the assessment visit are included.

    Time frame: Week 13 (end of treatment).

  2. Emotion-Recognition Accuracy at Two Months After Treatment

    Emotion recognition is assessed during the audiovisual speech and song task. After each video, participants select the emotion portrayed. Neutral and calm are combined into a single category for both target emotions and participant responses before scoring. Each valid response is scored 1 if it matches the target category after this grouping and 0 otherwise. Accuracy is expressed as the percentage of correct responses, from 0% to 100%, with higher values indicating more accurate recognition. Responses from both recordings at the assessment visit are included.

    Time frame: Two months after completion of the 13-week intervention.

  3. Emotion-Recognition Response Time at Week 13

    Response time for selecting the emotion portrayed in the audiovisual speech and song task, measured in seconds. Responses from both recordings at the assessment visit are included. Lower values indicate faster emotion-category responses. This measure is distinct from the response time for rating emotional intensity.

    Time frame: Week 13 (end of treatment).

  4. Emotion-Recognition Response Time at Two Months After Treatment

    Response time for selecting the emotion portrayed in the audiovisual speech and song task, measured in seconds. Responses from both recordings at the assessment visit are included. Lower values indicate faster emotion-category responses. This measure is distinct from the response time for rating emotional intensity.

    Time frame: Two months after completion of the 13-week intervention.

  5. Happiness Measures Composite Score at Week 6

    Subjective well-being is assessed using the Happiness Measures composite. The composite is calculated by averaging the general happiness rating, rescaled to 0-100, and the self-reported percentage of time feeling happy. Both component responses are required. Scores range from 0 to 100, with higher scores indicating greater happiness.

    Time frame: Week 6 (during treatment).

  6. Happiness Measures Composite Score at Week 13

    Subjective well-being is assessed using the Happiness Measures composite. The composite is calculated by averaging the general happiness rating, rescaled to 0-100, and the self-reported percentage of time feeling happy. Both component responses are required. Scores range from 0 to 100, with higher scores indicating greater happiness.

    Time frame: Week 13 (end of treatment).

  7. Happiness Measures Composite Score at Two Months After Treatment

    Subjective well-being is assessed using the Happiness Measures composite. The composite is calculated by averaging the general happiness rating, rescaled to 0-100, and the self-reported percentage of time feeling happy. Both component responses are required. Scores range from 0 to 100, with higher scores indicating greater happiness.

    Time frame: Two months after completion of the 13-week intervention.

  8. PDQ-39 Summary Index at Week 6

    Parkinson's disease-related quality of life is assessed using the 39-item Parkinson's Disease Questionnaire (PDQ-39). It covers mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. Items are scored 0-4. Each domain is converted to a 0-100 score, and the Summary Index is the mean of the eight domain scores. Index scores range from 0 to 100, with higher scores indicating poorer quality of life.

    Time frame: Week 6 (during treatment).

  9. PDQ-39 Summary Index at Week 13

    Parkinson's disease-related quality of life is assessed using the 39-item Parkinson's Disease Questionnaire (PDQ-39). It covers mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. Items are scored 0-4. Each domain is converted to a 0-100 score, and the Summary Index is the mean of the eight domain scores. Index scores range from 0 to 100, with higher scores indicating poorer quality of life.

    Time frame: Week 13 (end of treatment).

  10. PDQ-39 Summary Index at Two Months After Treatment

    Parkinson's disease-related quality of life is assessed using the 39-item Parkinson's Disease Questionnaire (PDQ-39). It covers mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. Items are scored 0-4. Each domain is converted to a 0-100 score, and the Summary Index is the mean of the eight domain scores. Index scores range from 0 to 100, with higher scores indicating poorer quality of life.

    Time frame: Two months after completion of the 13-week intervention.

  11. Emotion-Recognition Unbiased Hit Rate at Week 13

    Emotion-recognition accuracy is adjusted for response bias using Wagner's unbiased hit rate (Hu). For each emotion, Hu is the proportion of presentations of that emotion correctly identified multiplied by the proportion of uses of that response label that are correct. Scores range from 0 to 1, with higher scores indicating better recognition after adjustment for response bias. Scores are retained by emotion.

    Time frame: Week 13 (end of treatment).

  12. Emotion-Recognition Unbiased Hit Rate at Two Months After Treatment

    Emotion-recognition accuracy is adjusted for response bias using Wagner's unbiased hit rate (Hu). For each emotion, Hu is the proportion of presentations of that emotion correctly identified multiplied by the proportion of uses of that response label that are correct. Scores range from 0 to 1, with higher scores indicating better recognition after adjustment for response bias. Scores are retained by emotion.

    Time frame: Two months after completion of the 13-week intervention.

Other outcomes

  1. Perceived Emotional Intensity at Week 13

    Participants rate the intensity of the emotion portrayed in audiovisual speech and song stimuli on a scale from 1 to 9. Ratings from both recordings at the assessment visit are included. Higher ratings indicate greater perceived emotional intensity; they do not necessarily indicate improvement.

    Time frame: Week 13 (end of treatment).

  2. Perceived Emotional Intensity at Two Months After Treatment

    Participants rate the intensity of the emotion portrayed in audiovisual speech and song stimuli on a scale from 1 to 9. Ratings from both recordings at the assessment visit are included. Higher ratings indicate greater perceived emotional intensity; they do not necessarily indicate improvement.

    Time frame: Two months after completion of the 13-week intervention.

  3. Emotional-Intensity Rating Response Time at Week 13

    Time taken to provide an emotional-intensity rating during the audiovisual speech and song task, measured in seconds. Responses from both recordings at the assessment visit are included. Lower values indicate faster intensity-rating responses.

    Time frame: Week 13 (end of treatment).

  4. Emotional-Intensity Rating Response Time at Two Months After Treatment

    Time taken to provide an emotional-intensity rating during the audiovisual speech and song task, measured in seconds. Responses from both recordings at the assessment visit are included. Lower values indicate faster intensity-rating responses.

    Time frame: Two months after completion of the 13-week intervention.

  5. Participant Toronto Alexithymia Scale Total Score at Week 6

    Participant-reported alexithymia is assessed using the 20-item Toronto Alexithymia Scale (TAS-20), covering difficulty identifying feelings, difficulty describing feelings, and externally oriented thinking. Items are scored 1-5, with designated items reverse-scored. Complete questionnaire totals range from 20 to 100, with higher scores indicating greater alexithymia.

    Time frame: Week 6 (during treatment).

  6. Participant Toronto Alexithymia Scale Total Score at Two Months After Treatment

    Participant-reported alexithymia is assessed using the 20-item Toronto Alexithymia Scale (TAS-20), covering difficulty identifying feelings, difficulty describing feelings, and externally oriented thinking. Items are scored 1-5, with designated items reverse-scored. Complete questionnaire totals range from 20 to 100, with higher scores indicating greater alexithymia.

    Time frame: Two months after completion of the 13-week intervention.

  7. Participant Interpersonal Reactivity Index Total Score at Week 13

    Empathy-related traits are assessed using the 28-item Interpersonal Reactivity Index (IRI), covering perspective taking, empathic concern, fantasy, and personal distress. The study uses the summed score after designated items are reverse-scored, ranging from 0 to 112. Higher totals reflect higher combined scores across these dimensions; because personal distress is included, higher totals do not have a uniformly beneficial interpretation.

    Time frame: Week 13 (end of treatment).

  8. Participant Interpersonal Reactivity Index Total Score at Two Months After Treatment

    Empathy-related traits are assessed using the 28-item Interpersonal Reactivity Index (IRI), covering perspective taking, empathic concern, fantasy, and personal distress. The study uses the summed score after designated items are reverse-scored, ranging from 0 to 112. Higher totals reflect higher combined scores across these dimensions; because personal distress is included, higher totals do not have a uniformly beneficial interpretation.

    Time frame: Two months after completion of the 13-week intervention.

  9. Montreal Cognitive Assessment Total Score at Week 13

    Cognitive performance is assessed using the Montreal Cognitive Assessment (MoCA). Total scores range from 0 to 30, including the applicable education adjustment, with higher scores indicating better cognitive performance. Complete scored responses are required.

    Time frame: Week 13 (end of treatment).

  10. Montreal Cognitive Assessment Total Score at Two Months After Treatment

    Cognitive performance is assessed using the Montreal Cognitive Assessment (MoCA). Total scores range from 0 to 30, including the applicable education adjustment, with higher scores indicating better cognitive performance. Complete scored responses are required.

    Time frame: Two months after completion of the 13-week intervention.

  11. Participant Toronto Alexithymia Scale Total Score at Week 13

    Participant-reported alexithymia is assessed using the 20-item Toronto Alexithymia Scale (TAS-20), covering difficulty identifying feelings, difficulty describing feelings, and externally oriented thinking. Items are scored 1-5, with designated items reverse-scored. Complete questionnaire totals range from 20 to 100, with higher scores indicating greater alexithymia.

    Time frame: Week 13 (end of treatment).

  12. Participant Interpersonal Reactivity Index Total Score at Week 6

    Empathy-related traits are assessed using the 28-item Interpersonal Reactivity Index (IRI), covering perspective taking, empathic concern, fantasy, and personal distress. The study uses the summed score after designated items are reverse-scored, ranging from 0 to 112. Higher totals reflect higher combined scores across these dimensions; because personal distress is included, higher totals do not have a uniformly beneficial interpretation.

    Time frame: Week 6 (during treatment).

  13. Caregiver-Reported Participant Alexithymia Score at Week 6

    Caregivers assess the participant's difficulty identifying and describing feelings and externally oriented thinking using a proxy adaptation of the 20-item Toronto Alexithymia Scale (TAS-20). Items are reworded to refer to the participant. Complete questionnaire totals range from 20 to 100, with higher scores indicating greater perceived alexithymia in the participant.

    Time frame: Week 6 (during treatment).

  14. Caregiver-Reported Participant Alexithymia Score at Week 13

    Caregivers assess the participant's difficulty identifying and describing feelings and externally oriented thinking using a proxy adaptation of the 20-item Toronto Alexithymia Scale (TAS-20). Items are reworded to refer to the participant. Complete questionnaire totals range from 20 to 100, with higher scores indicating greater perceived alexithymia in the participant.

    Time frame: Week 13 (end of treatment).

  15. Caregiver-Reported Participant Alexithymia Score at Two Months After Treatment

    Caregivers assess the participant's difficulty identifying and describing feelings and externally oriented thinking using a proxy adaptation of the 20-item Toronto Alexithymia Scale (TAS-20). Items are reworded to refer to the participant. Complete questionnaire totals range from 20 to 100, with higher scores indicating greater perceived alexithymia in the participant.

    Time frame: Two months after completion of the 13-week intervention.

  16. Caregiver Beck Depression Inventory Total Score at Week 6

    Caregiver depressive symptoms are assessed using the 21-item Beck Depression Inventory (BDI). Items are scored 0-3 and combined into a total ranging from 0 to 63. Higher scores indicate more severe depressive symptoms in the caregiver.

    Time frame: Week 6 (during treatment).

  17. Caregiver Beck Depression Inventory Total Score at Week 13

    Caregiver depressive symptoms are assessed using the 21-item Beck Depression Inventory (BDI). Items are scored 0-3 and combined into a total ranging from 0 to 63. Higher scores indicate more severe depressive symptoms in the caregiver.

    Time frame: Week 13 (end of treatment).

  18. Caregiver Beck Depression Inventory Total Score at Two Months After Treatment

    Caregiver depressive symptoms are assessed using the 21-item Beck Depression Inventory (BDI). Items are scored 0-3 and combined into a total ranging from 0 to 63. Higher scores indicate more severe depressive symptoms in the caregiver.

    Time frame: Two months after completion of the 13-week intervention.

  19. Caregiver Relative Stress Scale Total Score at Week 6

    Caregiver stress is assessed using the 15-item Relative Stress Scale (RSS), covering emotional distress, social distress, and negative feelings associated with caregiving. Items are scored 0-4, giving a total from 0 to 60. Higher scores indicate greater caregiver stress.

    Time frame: Week 6 (during treatment).

  20. Caregiver Relative Stress Scale Total Score at Week 13

    Caregiver stress is assessed using the 15-item Relative Stress Scale (RSS), covering emotional distress, social distress, and negative feelings associated with caregiving. Items are scored 0-4, giving a total from 0 to 60. Higher scores indicate greater caregiver stress.

    Time frame: Week 13 (end of treatment).

  21. Caregiver Relative Stress Scale Total Score at Two Months After Treatment

    Caregiver stress is assessed using the 15-item Relative Stress Scale (RSS), covering emotional distress, social distress, and negative feelings associated with caregiving. Items are scored 0-4, giving a total from 0 to 60. Higher scores indicate greater caregiver stress.

    Time frame: Two months after completion of the 13-week intervention.

  22. Caregiver General Health Questionnaire Total Score at Week 6

    Caregiver psychological distress is assessed using the 12-item General Health Questionnaire (GHQ-12). Likert scoring of 0-3 per item is used, giving a total score from 0 to 36. Higher scores indicate greater psychological distress.

    Time frame: Week 6 (during treatment).

  23. Caregiver General Health Questionnaire Total Score at Week 13

    Caregiver psychological distress is assessed using the 12-item General Health Questionnaire (GHQ-12). Likert scoring of 0-3 per item is used, giving a total score from 0 to 36. Higher scores indicate greater psychological distress.

    Time frame: Week 13 (end of treatment).

  24. Caregiver General Health Questionnaire Total Score at Two Months After Treatment

    Caregiver psychological distress is assessed using the 12-item General Health Questionnaire (GHQ-12). Likert scoring of 0-3 per item is used, giving a total score from 0 to 36. Higher scores indicate greater psychological distress.

    Time frame: Two months after completion of the 13-week intervention.

07

Study locations

1 site
  • SMART Lab, Toronto Metropolitan University
    Toronto, Ontario M5B2K3, Canada
08

References and documents

Publications

  • Livingstone SR, Vezer E, McGarry LM, Lang AE, Russo FA. Deficits in the Mimicry of Facial Expressions in Parkinson's Disease. Front Psychol. 2016 Jun 7;7:780. doi: 10.3389/fpsyg.2016.00780. eCollection 2016. PubMed 27375505 ↗

Individual participant data

Plan to share: Yes — De-identified individual participant data underlying the trial results reported in the publication will be shared. These will include processed facial surface electromyography (sEMG) data, behavioural task data, motor and cognitive assessment scores, and participant and caregiver questionnaire scores. The datasets will be accompanied by a data dictionary describing the variables and their coding, together with analysis scripts. Anonymised raw data underlying the reported analyses will also be available upon reasonable request, subject to a data-sharing agreement.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code

Time frame: The study protocol and statistical analysis plan on OSF, and the de-identified analysis datasets, data dictionary and analytic code on Zenodo, will become publicly available upon publication of the associated article. Anonymised raw data and a blank, unsigned copy of the approved informed consent form will be available on request from the same date. No end date for access is planned.

Access criteria: Upon publication of the associated article, anyone will be able to access the de-identified analysis datasets, data dictionary and analytic code through Zenodo, and the study protocol and statistical analysis plan through OSF. Researchers may request anonymised raw data underlying the reported analyses from the corresponding author, Steven R. Livingstone, using the contact details provided in the publication. Access to these raw data will be provided upon reasonable request, subject to a data-sharing agreement. A blank, unsigned copy of the approved informed consent form will also be available on request from Steven R. Livingstone from the same date.

Data sharing details ↗ · doi.org

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2013 to primary completion in Oct 2014, 15 months.

Of 1,302 non-industry interventional studies with no phase under Parkinson Disease, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's 15 months is below that.

Counting every sponsor, half of 1,375 studies reached it within 24 months; a quarter within 11 and three quarters within 44.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 23, 2026
First posted
Oct 29, 2026
StartActual
Jun 28, 2013
Primary completionActual
Oct 24, 2014
CompletionActual
Oct 24, 2014
Last update
Oct 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 29, 2026
Show all 1 update
  1. Oct 29, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07905612
Lead sponsor
Toronto Metropolitan University
Collaborators
University Health Network, Toronto, University of Toronto, Parkinson Society Canada
Responsible party
Frank Russo (Professor, Toronto Metropolitan University) — Principal investigator
First posted
Oct 29, 2026
Start date
Jun 28, 2013
Primary completion
Oct 24, 2014
Completion
Oct 24, 2014
Last update
Oct 29, 2026

Study contacts

Frank A Russo, PhD
principal investigator · Toronto Metropolitan University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

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