ClinicalTrials.gg
CompletedNCT07568769ES-FPUpdated Jun 3, 2026

Exteroceptive Stimulation for Facial Palsy After Stroke

An interventional study of Exteroceptive Stimulation and Conventional Physiotherapy in Stroke and Facial Palsy, sponsored by University of Faisalabad. Completed at 1 site in Pakistan. Open to participants aged 40 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-06-03.

Sponsored by University of Faisalabad · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Aug 2025, registered Apr 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
40 Years to 55 Years
Sex
All
01

Study summary

Stroke is a leading cause of long-term disability worldwide and frequently results in central facial palsy, which manifests as facial asymmetry, impaired muscle control, and reduced functional ability. These impairments can affect speech, emotional expression, and overall quality of life. Conventional physiotherapy is commonly used to manage post-stroke facial palsy; however, the additional benefit of sensory-based rehabilitation approaches remains insufficiently explored, particularly in clinical settings with limited resources.

This study was conducted to evaluate whether the addition of exteroceptive stimulation to conventional physiotherapy leads to greater improvement in facial symmetry and functional outcomes compared to conventional physiotherapy alone. Exteroceptive stimulation aims to enhance sensory input and facilitate neuromuscular activation, potentially improving motor recovery in affected facial muscles.

In this double-blind randomized controlled trial, a total of 36 participants diagnosed with post-stroke facial palsy were recruited and randomly allocated into two groups. The experimental group received exteroceptive stimulation in addition to conventional physiotherapy, while the control group received conventional physiotherapy alone. Both interventions were administered over a period of four weeks.

Outcome measures were assessed at baseline and at the end of the intervention period. The primary outcome was lip angle deviation, used as an indicator of facial symmetry. Secondary outcomes included facial function and disability assessed using standardized tools such as the Facial Disability Index and the Synkinesis Assessment Questionnaire.

The findings of this study aim to provide evidence on the effectiveness of integrating sensory-based techniques into routine rehabilitation programs for post-stroke facial palsy. The results may support the development of more comprehensive and effective rehabilitation strategies to improve patient outcomes.

Read the detailed description

Post-stroke facial palsy is a frequent neurological complication resulting from upper motor neuron lesions affecting facial nerve pathways. It commonly presents with facial asymmetry, impaired voluntary muscle control, and altered emotional expression. These deficits can interfere with communication, oral competence, and social interaction, ultimately impacting functional independence and quality of life. Despite its clinical importance, rehabilitation strategies targeting facial motor recovery remain relatively underdeveloped compared to limb rehabilitation.

Conventional physiotherapy approaches for facial palsy typically focus on facial muscle exercises, facilitation techniques, and functional retraining aimed at improving motor control and symmetry. While these approaches are widely used in clinical practice, their outcomes are often variable, and recovery may be incomplete. In recent years, there has been increasing interest in integrating sensory-based interventions into neurorehabilitation, based on the premise that sensory input plays a critical role in motor relearning and cortical reorganization.

Exteroceptive stimulation is a sensory-based intervention designed to enhance afferent input through external stimuli applied to the skin and underlying tissues. By increasing sensory feedback, it may facilitate neuromuscular activation, improve motor coordination, and support adaptive neuroplastic changes. Although such approaches have shown promise in broader neurorehabilitation contexts, their role in the management of post-stroke facial palsy has not been sufficiently investigated through controlled clinical trials.

This study was designed as a double-blind randomized controlled trial to examine the additional benefit of exteroceptive stimulation when combined with conventional physiotherapy. Participants diagnosed with post-stroke facial palsy were recruited from tertiary care settings and randomly assigned to one of two intervention groups using a computer-generated randomization process. Measures were taken to ensure blinding of participants and outcome assessors to minimize bias.

The intervention was delivered over a defined treatment period, with both groups receiving standardized conventional physiotherapy to ensure consistency of baseline care. The experimental group received an additional structured program of exteroceptive stimulation targeting affected facial regions. The protocol was designed to be feasible within routine clinical practice and reproducible in similar healthcare settings.

Outcome assessments were conducted at predefined time points using validated clinical instruments to capture changes in facial symmetry, functional ability, and associated complications such as synkinesis. The selection of these measures was based on their relevance to clinical presentation and their use in prior rehabilitation research.

Statistical analysis was performed to evaluate changes over time within each group and to compare differences between groups following the intervention period. Appropriate parametric tests were applied after assessment of data distribution. A threshold for statistical significance was established a priori.

This study aims to contribute to the existing body of evidence by providing controlled clinical data on the role of sensory-based adjunct therapies in facial rehabilitation following stroke. The findings are expected to inform clinical practice by clarifying whether the addition of exteroceptive stimulation offers meaningful benefits beyond conventional physiotherapy alone. Furthermore, the study may serve as a basis for future research exploring optimized rehabilitation protocols, longer follow-up durations, and larger multi-center trials.

02

Conditions studied

  • Stroke
  • Facial Palsy

Keywords

  • Stroke Rehabilitation
  • Facial Paralysis
  • Exteroceptive Stimulation
03

In context

Stroke

8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.

This study's enrollment of 36 is below the median of 49 across 6,024 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

University of Faisalabad is the lead sponsor of 86 studies on the registry; 27 are open to participants now.

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

04

Who can participate

Ages eligible
40 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

  • Patients diagnosed with post-stroke facial palsy
  • Age between 40 and 55 years
  • Both male and female participants
  • Acute onset of facial weakness within 1-3 weeks
  • Non-traumatic onset of disease
  • Commitment to comply with electrical stimulation treatment

Exclusion criteria

Exclusion Criteria:

  • Participation in other therapies for facial nerve
  • Presence of neoplastic tumor, Pregnancy, Cardiac, Excessive perspiration, Psychiatric illness or Mental impairment, Neurotmesis, Post-surgical cases of heart and brain surgery
  • Bilateral facial palsy due to demyelinating disease e.g. motor neuron disease, trigeminal neuralgia, Open wounds/ulcers, ENT impairment/Otitis Media, Repetitive previous history of stroke
  • Invasive cardiac instrumentation such as endarterectomy or stent placement within 30 days prior to admission in ICU were excluded
05

Study design

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

Study arms

  • Experimental
    Exteroceptive Stimulation

    Exteroceptive stimulation was applied to the affected side of the face using structured sensory techniques, including light touch, stroking, tapping, and graded pressure over the perioral, cheek, and nasolabial regions. The intervention was delivered by a trained physiotherapist in a standardized sequence to enhance sensory input and facilitate neuromuscular activation.

    Other: Exteroceptive Stimulation · Other: Conventional Physiotherapy

  • Active comparator
    Conventional Physiotherapy

    Conventional physiotherapy included a structured facial rehabilitation program comprising facial muscle exercises, facilitation techniques, and functional retraining aimed at improving symmetry and muscle coordination.

    Other: Conventional Physiotherapy

Interventions

  • OtherExteroceptive Stimulation

    Exteroceptive stimulation was applied to the affected side of the face using structured sensory techniques, including light touch, stroking, tapping, and graded pressure over the perioral, cheek, and nasolabial regions. The intervention was delivered by a trained physiotherapist in a standardized sequence to enhance sensory input and facilitate neuromuscular activation. Each session lasted approximately 30-40 minutes and was administered 5 days per week for 4 weeks in a clinical setting. This intervention was provided in combination with conventional physiotherapy.

  • OtherConventional Physiotherapy

    Conventional physiotherapy included a structured facial rehabilitation program comprising facial muscle exercises, facilitation techniques, and functional retraining to improve symmetry and coordination. Sessions were delivered by a qualified physiotherapist, lasting approximately 30-40 minutes, 5 days per week for 4 weeks. This intervention was provided alone in the control group and in combination with exteroceptive stimulation in the experimental group.

06

What researchers measure

Primary outcomes

  1. Change in Lip Angle Deviation

    Lip angle deviation was measured using standardized facial symmetry assessment techniques to evaluate improvement in facial alignment.

    Time frame: Baseline and Week 4

Secondary outcomes

  1. Facial Disability Index (FDI)

    Assessment of physical and social function using validated scoring system (FDI-P, FDI-S, FDI-T). The Facial Disability Index is a validated scale used to assess functional limitations and social well-being in patients with facial disorders. It consists of two subscales: Physical Function and Social Function, which are combined to generate a total score. Scores range from 0 to 100, with higher scores indicating better functional status and improved quality of life.

    Time frame: Baseline and Week 4

  2. Synkinesis Assessment Questionnaire (SAQ)

    Measurement of synkinesis severity using a structured questionnaire. The Synkinesis Assessment Questionnaire is a patient-reported outcome measure used to evaluate the severity of synkinesis. The total score ranges from 0 to 100, with higher scores indicating greater severity of synkinesis and worse clinical condition.

    Time frame: Baseline and Week 4

07

Study locations

1 site
  • Tertiary Care Hospitals, Faisalabad, Pakistan
    Faisalābad, Punjab Province 3800, Pakistan
08

References and documents

Publications

  • 1. Albaret G, Domergue H. Stroke and stroke rehabilitation. Pathy's Princ Pract Geriatr Med. Published online February 18, 2022:619-634. doi:10.1002/9781119484288.CH48 2. Unnithan AKA, Das JM, Mehta P. Hemorrhagic Stroke. In Statpearls. Published online December 13, 2025:1-12. 3. Fulk GD., Chui KK. O'Sullivan & Schmitz's physical rehabilitation. Published online 2024:1337. 4. Choi JH, Kim BR, Han EY, Kim SM. The Effect of Dual-Task Training on Balance and Cognition in Patients With Subacute Post-Stroke. Ann Rehabil Med. 2015;39(1):81. doi:10.5535/ARM.2015.39.1.81 5. Junior VA dos S, Santos M de S, Ribeiro NM da S, Maldonado IL. Combining Proprioceptive Neuromuscular Facilitation and Virtual Reality for Improving Sensorimotor Function in Stroke Survivors: A Randomized Clinical Trial. J Cent Nerv Syst Dis. 2019;11. doi:10.1177/1179573519863826 6. Hashmi M, Khan M, Wasay M. Growing Burden of Stroke in Pakistan: A Review of Progress and Limitations. Int J Stroke. 2013;8(7):575-581. doi:10.1111/J.1747-4949.2012.00827.X 7. Schimmel M, Voegeli G, Duvernay E, Leemann B, Müller F. Oral tactile sensitivity and masticatory performance are impaired in stroke patients. J Oral Rehabil. 2017;44(3):163-171. doi:10.1111/JOOR.12482 8. Schimmel M, Ono T, Lam OLT, Müller F. Oro-facial impairment in stroke patients. J Oral Rehabil. 2017;44(4):313-326. doi:10.1111/JOOR.12486 9. Johal A, Dunne B, Bolooki H, Sandler C. Oral Health-Related Quality of Life (OHRQoL), Pain and Side Effects in Adults Undergoing Different Orthodontic Treatment Modalities: A Systematic Review and Meta-Analysis. Healthc 2025, Vol 13,. 2025;13(24). doi:10.3390/HEALTHCARE13243317 10. Taj F, Zahid R, Syeda UER, Murtaza M, Ahmed S, Kamal AK. Risk Factors of Stroke in Pakistan: A Dedicated Stroke Clinic Experience. Can J Neurol Sci. 2010;37(2):252-257. doi:10.1017/S0317167100010015 11. Walcott BP, Miller JC, Kwon CS, et al. Outcomes in severe middle cerebral artery ischemic stroke. Neurocrit Care. 2014;21(1)

Individual participant data

Plan to share: No

09

Timeline

Tracking 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 Aug 2025 to primary completion in Dec 2025, 4 months.

Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's 4 months is below that.

Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.

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

Registered
Apr 28, 2026
First posted
May 6, 2026
StartActual
Aug 1, 2025
Primary completionActual
Dec 24, 2025
CompletionActual
Dec 24, 2025
Last update
Jun 3, 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.
No changes since tracking began. The registry record was last updated on Jun 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07568769
Lead sponsor
University of Faisalabad
Responsible party
Dr. Marium Zafar (Associate professor/ Head Department of Rehabilitation sciences, University of Faisalabad) — Principal investigator
First posted
May 6, 2026
Start date
Aug 1, 2025
Primary completion
Dec 24, 2025
Completion
Dec 24, 2025
Last update
Jun 3, 2026

Study contacts

Dr Muhammad Ateeb, PhD Public Health
study chair · Research Associate, The University of Faisalabad, Faisalabad 38000, Pakistan

Oversight

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

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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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