ClinicalTrials.gg
RecruitingNCT07931040RV-PARKUpdated Nov 12, 2026

Virtual Reality for Motor and Cognitive Function in People With Parkinson's Disease

An interventional study of Stationary Cycling and Stationary Cycling Combined with Virtual Reality in PARKINSON DIS, sponsored by Universidade Metodista de Piracicaba. Recruiting at 1 site in Brazil. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by Universidade Metodista de Piracicaba · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Jun 2026, registered Oct 2026).
  • Started Jun 2026; still recruiting 5 months later.
Updated Nov 12, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
50 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 103 studies in Parkinson Disease with a site in Brazil — 19 open to participants now, 22 under way, 1 of them phase 3. Parkinson Disease · Brazil.

Planned enrollment
51st of 95
30 · median 34
Started
2026
with 5 others
No phase
81 of 103
15 open now
Primary completion
2027-03
later than 16 of 21 live
Registered
102nd of 103
by date
Lead sponsor
6 of 103
Universidade Metodista de Piracicaba

Among the 103 studies in Parkinson Disease with a site in Brazil, this one is the 51st largest by planned enrollment of the 95 interventional ones that give a count, is one of 6 that started in 2026, is one of 81 with no phase, reaches primary completion later than 16 of the 21 other live ones, and was the 102nd registered.

Parkinson Disease

4,576 studies on the registry are indexed under Parkinson Disease; 1,087 are open to participants now.

Browse Parkinson Disease studies →

Open to participants now

19 of the 103 studies in Parkinson Disease with a site in Brazil are open now. Recruiting first, the newest first:

13 more — sign in →

All 19 open studies →

A study can be open while its sites in Brazil have not opened yet or have stopped. Only those recruiting at a site in Brazil →

Who these studies take

Of the 749 Parkinson Disease studies recruiting now, 311 (42%) set no upper age limit and 127 (17%) stop at 75 or younger; 64 take children under 18; 189 take healthy volunteers.

This study: 50 Years to 80 Years · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 103 studies in Parkinson Disease with a site in Brazil, or all of them as a file.
02

Study summary

Parkinson's disease can affect movement, balance, and cognitive function, potentially making daily activities more difficult. This randomized clinical trial aims to investigate whether combining virtual reality with stationary cycling produces different effects on motor and cognitive function compared with stationary cycling alone in people with Parkinson's disease.

Participants will be randomly assigned to one of two groups: a control group performing stationary cycling and an intervention group performing stationary cycling while using a virtual reality headset. The intervention will consist of 12 sessions over six weeks, with two sessions per week. Each session will last 40 minutes, including 5 minutes for vital sign assessment before exercise, 30 minutes of cycling, and 5 minutes for vital sign reassessment after exercise.

Assessments will be conducted before the intervention, immediately after the six-week program, and at follow-up. The study will examine whether adding virtual reality to stationary cycling may be a useful approach for rehabilitation in people with Parkinson's disease.

Read the detailed description

Parkinson's disease is a progressive neurological disorder associated with motor impairments and may also affect cognitive function. Rehabilitation strategies involving physical exercise may help address functional limitations in this population. Virtual reality is a technology that provides interactive and immersive environments and may be used to complement conventional exercise-based rehabilitation.

This randomized clinical trial will investigate the effects of stationary cycling combined with virtual reality on motor and cognitive function in people with Parkinson's disease. The study will compare the combined intervention with stationary cycling alone to examine whether the addition of virtual reality is associated with different outcomes.

Participants will be randomly allocated to one of two study groups. The control group will perform stationary cycling without virtual reality, while the intervention group will perform stationary cycling while using a virtual reality headset. Both groups will follow the same intervention schedule: two sessions per week for six weeks, for a total of 12 sessions.

Each session will last 40 minutes. The first five minutes will be used to assess vital signs before exercise, followed by 30 minutes of stationary cycling. The final five minutes will be used to reassess vital signs after exercise. The intervention procedures will be conducted according to the study protocol.

Study assessments will take place at baseline, immediately after completion of the six-week intervention, and at follow-up. These assessments will be used to evaluate changes in motor and cognitive function and other clinical outcomes specified in the study protocol. The comparison between groups and across assessment time points will help determine whether the addition of virtual reality to stationary cycling is associated with different outcomes compared with stationary cycling alone.

The study is expected to contribute evidence regarding the potential role of virtual reality as an adjunct to exercise-based rehabilitation for people with Parkinson's disease.

03

Conditions studied

  • PARKINSON DIS

Browse trials for

Keywords

  • virtual reality
  • stationary cycling
  • parkinson disease
  • motor function
04

Who can participate

Ages eligible
50 Years to 80 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

  1. Male and female participants aged 50 to 80 years.
  2. Clinical diagnosis of Parkinson's disease confirmed by a medical report.
  3. Hoehn and Yahr stages 1 to 3.
  4. Stable medication regimen during the month preceding the start of the interventions.
  5. Ability to walk independently.
  6. Willingness to participate in the study and provide written .

Exclusion criteria

Exclusion Criteria:

  1. Other neurological, orthopedic, or cardiorespiratory conditions that prevent participation in the virtual reality intervention.
  2. Current participation in physical therapy and/or other physical activities that could confound the study results.
  3. Low vision or blindness that prevents participation in the virtual reality intervention.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

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

Study arms

  • Active comparator
    Arm 1 - Control group

    Arm Label: Stationary Cycling Combined Alone Participants will perform stationary cycling for 30 minutes per session, twice a week for six weeks, totaling 12 sessions. During cycling, participants will receive verbal instructions to increase or decrease their pedaling speed. Each 40-minute session will include 5 minutes for vital sign assessment before exercise, 30 minutes of cycling, and 5 minutes for vital sign reassessment after exercise. No virtual reality will be used.

    Behavioral: Stationary Cycling

  • Experimental
    Arm 2 - Intervention group

    Participants will perform exercises on a stationary bicycle combined with virtual reality, for 30 minutes per session, twice a week, over the course of six weeks, totaling 12 sessions. During the exercise, participants will use a Meta Quest 3S virtual reality headset to experience an immersive virtual environment while pedaling. Each 40-minute session will include 5 minutes for the assessment of vital signs before the exercise, 30 minutes of cycling combined with virtual reality, and 5 minutes for the reassessment of vital signs after the exercise.

    Behavioral: Stationary Cycling Combined with Virtual Reality

Interventions

  • BehavioralStationary Cycling

    Participants will perform stationary cycling for 30 minutes per session, twice weekly for six weeks, totaling 12 sessions. Each 40-minute session will include 5 minutes for vital sign assessment before exercise and 5 minutes for vital sign reassessment after exercise.

  • BehavioralStationary Cycling Combined with Virtual Reality

    Participants will perform stationary cycling while wearing a Meta Quest 3S virtual reality headset, which will provide an immersive virtual environment with visual cues guiding changes in pedaling speed. Participants will independently increase or decrease their pedaling speed according to the visual cues presented in the virtual environment, without verbal instructions. The intervention will consist of 30 minutes of cycling combined with virtual reality per session, twice a week for six weeks, totaling 12 sessions. Each 40-minute session will include 5 minutes for vital sign assessment before exercise, 30 minutes of cycling combined with virtual reality, and 5 minutes for vital sign reassessment after exercise.

06

What researchers measure

Primary outcomes

  1. Montreal Cognitive Assessment (MoCA)

    The Montreal Cognitive Assessment (MoCA) is a standardized screening tool used to assess global cognitive function. It evaluates multiple cognitive domains, including attention, concentration, executive functions, memory, language, visuospatial abilities, abstraction, calculation, and orientation. The total score ranges from 0 to 30 points, with higher scores indicating better cognitive performance and lower scores indicating poorer cognitive performance. An additional point is added for individuals with 12 or fewer years of formal education, according to the official scoring guidelines, provided that the maximum score does not exceed 30 points. The MoCA will be used to evaluate changes in cognitive performance throughout the study.

    Time frame: At baseline (pre-intervention), 12 weeks (post-intervention), and 30 days after the post-intervention assessment (follow-up).

Secondary outcomes

  1. Functional Gait Assessment (FGA)

    The Functional Gait Assessment (FGA) is a clinical tool used to assess dynamic balance and postural stability during walking under different conditions. It consists of 10 items, each scored on a 4-point ordinal scale ranging from 0 (severe impairment) to 3 (normal performance), with a total score ranging from 0 to 30 points. Higher scores indicate better gait performance and dynamic balance, whereas lower scores indicate greater impairment. The FGA will be used to assess changes in gait performance and dynamic balance over the study period.

    Time frame: At baseline (pre-intervention), 12 weeks (post-intervention), and 30 days after the post-intervention assessment (follow-up).

  2. Baropodometric Assessment (Foot Pressure Analysis)

    Baropodometric assessment is a non-invasive, instrument-based method used to evaluate plantar pressure distribution and foot-ground interaction during standing and/or walking. It provides quantitative measurements of plantar pressure and load distribution between the feet, allowing the analysis of static and dynamic plantar pressure characteristics. The assessment does not produce a single standardized total score; instead, results are expressed through specific quantitative parameters, such as mean plantar pressure, peak plantar pressure, and pressure distribution across different foot regions. These measurements will be used to evaluate changes in plantar pressure distribution and postural control throughout the study period.

    Time frame: At baseline (pre-intervention), 12 weeks (post-intervention), and 30 days after the post-intervention assessment (follow-up).

  3. Parkinson's Disease Questionnaire (PDQ-39)

    The Parkinson's Disease Questionnaire (PDQ-39) is a disease-specific quality-of-life questionnaire designed to assess the impact of Parkinson's disease on patients' daily lives. It consists of 39 items distributed across eight domains: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. Each item is scored on a 5-point ordinal scale ranging from 0 (never) to 4 (always or cannot do at all), reflecting the frequency of difficulties experienced during the previous month. Domain scores are converted to a scale ranging from 0 to 100, where 0 represents no problems and 100 represents the maximum level of problems. Higher scores indicate greater difficulties and poorer health-related quality of life, whereas lower scores indicate fewer difficulties and better health-related quality of life. The PDQ-39 will be used to assess changes in health-related quality of life throughout the study period.

    Time frame: At baseline (pre-intervention), 12 weeks (post-intervention), and 30 days after the post-intervention assessment (follow-up).

  4. Unified Parkinson's Disease Rating Scale (UPDRS)

    The Unified Parkinson's Disease Rating Scale (UPDRS) is a standardized clinical scale used to assess the severity and progression of Parkinson's disease. It consists of four parts: Part I, Mentation, Behavior, and Mood (4 items; score range: 0-16); Part II, Activities of Daily Living (13 items; score range: 0-52); Part III, Motor Examination (14 items; score range: 0-56); and Part IV, Complications of Therapy (11 items; score range: 0-44). Each item is scored from 0 to 4, according to the original scale guidelines. The total score ranges from 0 to 168 points, with higher scores indicating greater disease severity and impairment, whereas lower scores indicate less severe symptoms and impairment. The UPDRS will be used to assess changes in the clinical manifestations of Parkinson's disease throughout the study period.

    Time frame: At baseline (pre-intervention), 12 weeks (post-intervention), and 30 days after the post-intervention assessment (follow-up).

  5. Timed Up and Go (TUG) Test

    The Timed Up and Go (TUG) test is a clinical assessment tool used to evaluate functional mobility, dynamic balance, and gait performance. The test measures the time required for a participant to stand up from a chair, walk 3 meters at a comfortable and safe pace, turn around, walk back to the chair, and sit down again. The test is performed according to standardized procedures, and the completion time is recorded in seconds. The test does not have a standardized minimum or maximum score, as the outcome is expressed as completion time in seconds. Shorter completion times indicate better functional mobility and performance, whereas longer times indicate poorer functional mobility and potentially impaired dynamic balance. The TUG test will be used to assess changes in functional mobility throughout the study period.

    Time frame: At baseline (pre-intervention), 12 weeks (post-intervention), and 30 days after the post-intervention assessment (follow-up).

  6. Freezing of Gait Questionnaire (FOG-Q)

    The Freezing of Gait Questionnaire (FOG-Q) is a disease-specific assessment tool used to evaluate the severity and impact of freezing of gait in individuals with Parkinson's disease. It consists of six items assessing the frequency and duration of freezing episodes, their impact on walking, and related gait difficulties. Each item is scored on a 5-point ordinal scale ranging from 0 to 4, with a total score ranging from 0 to 24 points. A score of 0 indicates the absence of freezing-related symptoms, whereas a score of 24 indicates the maximum severity. Higher scores indicate greater severity and impact of freezing of gait, while lower scores indicate less severe symptoms. The FOG-Q will be used to assess changes in freezing of gait symptoms throughout the study period.

    Time frame: At baseline (pre-intervention), 12 weeks (post-intervention), and 30 days after the post-intervention assessment (follow-up).

  7. Six-Minute Walk Test (6MWT)

    The Six-Minute Walk Test (6MWT) is a standardized functional exercise test used to assess functional exercise capacity and walking endurance. Participants are instructed to walk for six minutes along a flat, standardized course, covering as much distance as possible at their own pace while maintaining a safe level of exertion. The total distance walked is measured in meters and recorded as the primary outcome of the test. The test does not have a standardized minimum or maximum score, as the outcome is expressed as the distance covered in meters. Greater distances indicate better functional exercise capacity and walking endurance, whereas shorter distances indicate poorer functional exercise capacity. The 6MWT will be used to assess changes in walking performance throughout the study period.

    Time frame: At baseline (pre-intervention), 12 weeks (post-intervention), and 30 days after the post-intervention assessment (follow-up).

07

Study locations

1 of 1 sites recruiting
  • UEAFTO - Unidade de Fisioterapia e Terapia Ocupacional, Belém, Pará
    Belém, 66087-670, Brazil
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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

Started Jun 2026 (actual). Primary completion is estimated for Mar 2027, 9 months after the start.

Of 1,293 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 44. This study's planned 9 months is below that.

Counting every sponsor, half of 1,369 studies reached it within 25 months; a quarter within 12 and three quarters within 44.

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

Registered
Oct 29, 2026
First posted
Nov 12, 2026
StartActual
Jun 1, 2026
Primary completionEst.
Mar 31, 2027
CompletionEst.
Jul 31, 2027
Last update
Nov 12, 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
Nov 12, 2026
Show all 1 update
  1. Nov 12, 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
NCT07931040
Lead sponsor
Universidade Metodista de Piracicaba
Responsible party
Luciane Lobato Sobral (Professor, PhD, Universidade Metodista de Piracicaba) — Principal investigator
First posted
Nov 12, 2026
Start date
Jun 1, 2026
Primary completion
Mar 31, 2027 (estimated)
Completion
Jul 31, 2027 (estimated)
Last update
Nov 12, 2026

Oversight

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

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