Parkinson DiseaseNCT06838741
Effects of Virtual Reality and Otago Exercises in Parkinson's Disease Patients.
A study testing otago exercises and virtual reality in people with Parkinson Disease, run by Riphah International University at 1 site in Pakistan.
Trial summary
Parkinson's disease, the second most common neurological condition, significantly affects motor function, gait, balance, and daily living activities. There is a pressing need for advanced therapies that specifically address these challenges. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- otago exercises and virtual reality
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2024to 2 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The age group of 50 to 70 years will be included (19).
- Both male and female (20) .
- Patients diagnosed with Parkinson's disease of Hoehn and Yahr stage (1-3)
- Patient should be able to stand 10 minutes at least without assistance.
- Patients should be able to walk with or without assistance.
- Mini mental score should be higher than 24
Who cannot join
- Recent surgery or any fracture.
- Any visual and hearing impairments.
- Any pathology that may impair therapy
- Joint pain or musculoskeletal problem that interfered with therapy (22).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Effects of Virtual Reality and Otago Exercises on Balance, Gait and Activities of Daily Living in Parkinson's Disease Patients.
Parkinson's disease, the second most common neurological condition, significantly affects motor function, gait, balance, and daily living activities. There is a pressing need for advanced therapies that specifically address these challenges. This study explores the potential benefits of virtual reality and Otago exercises, which may enhance balance and gait by providing sensory feedback crucial for motor learning and relearning. The randomized clinical trial will enroll 74 participants with Parkinson's disease, selected through non-probability convenience sampling. After obtaining synopsis approval, participants will be randomly assigned to one of two groups: Group A will engage in Otago exercises, while Group B will participate in virtual reality sessions. Each treatment session will last for 25 minutes. To evaluate outcomes, various tools will be employed, including the Berg Balance Scale for static balance and the Timed Up and Go test for dynamic balance. The 6-Minute Walk Test will measure gait performance, and the Unified Parkinson Disease Rating Scale will assess activities of daily living. Data normality will be determined using the Kolmogorov-Smirnov test, with subsequent analyses employing either one-way ANOVA or the Kruskal-Wallis test, depending on data distribution, to draw meaningful conclusions regarding treatment efficacy.
Read the detailed description
The second most prevalent neurological condition is Parkinson disease. It impairs motor function, gait, balance, and daily living tasks. More advanced therapies that target balance, gait, and activities of daily living are required. Virtual reality helps in cognitive and motor improvement by creating a virtual environment. While otago exercise helps to improve balance and coordination and reduce the risk of falls in Parkinson patients. Virtual reality and otago exercises may help to improve balance and gait by providing sensory feedback that will help in motor learning and relearning. This study will compare the effects of virtual reality and otago exercises on balance, gait, and activities of daily living in patients with Parkinson's disease.
This randomized clinical trial will be carried out in a study setting 10 months after the approval of synopsis. In this study, 74 participants who will meet inclusion criteria through a non-probability convenience sampling technique will be included. Participants will be randomly assigned into 2 groups using online research randomizer software. Group A and Group B participants will receive Otago exercises and virtual reality, respectively. Total treatment time will be 25 minutes. The outcome measuring tools used will be Berg balance scale for static balance and time-up and go to measure dynamic balance; a 6-minute walk test will be used for gait, and Unified Parkinson disease Rating scale for activities of daily living. Kolmogorv-Smirnov test will be used to check normality of data. If data will be normally distributed, a one-way ANOVA will be used, and for non-parametric data, the Kruskal-Wallis test will be used.
Type (Exercises):
Weeks 1-2: Foundation and Familiarization Balance Exercises: Start with basic static balance tasks (e.g., standing on one leg, weight shifting) within a VR environment.
Gait preparation: introduce walking simulations on level ground to familiarize participants with VR-based gait training.
ADL Simulation: Initiate simple ADL tasks in VR, such as reaching for objects or virtual button pressing.
Weeks 3-4: Balance and Coordination Development
- Dynamic Balance: Progress to dynamic balance exercises (e.g., stepping over virtual obstacles, balancing on unstable surfaces in VR).
- Coordination Training: Incorporate dual-task activities where participants perform balance exercises while engaging in cognitive tasks within the VR environment.
- Functional ADLs:
- Conditions
- Parkinson Disease
- Being tested
- otago exercises, virtual reality
- Keywords
- Activities of daily living, Balance, gait, otago exercises, Parkinsons disease, Virtual reality
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
otago exercisesProcedure or surgery
A walking program is given to participants, with the goal of including two 30-minute walking sessions each week (which can be divided into shorter segments, like three ten-minute blocks).
Exercises Start exercises with 10 repetition maximum STRENGTH Knee extensor Hold for 3-5 seconds Knee flexor Hold for 3-5 seconds Hip adductor Hold for 3-5 seconds Ankle planter-flexion Calf raises Ankle dorsiflexion Toe raise BALANCE Knee bends Backwards walking Upto 30 minutes Walking and turning around 5-10 minutes Sideways walking Tandem stance Heel to toe stand Tandem walk One leg stand Heel walking Toe walk Heel toe walking backwards Sit to stand Stair walking
virtual realityDevice
Begin with 20-30 minutes per session and extend to 30-45 minutes as tolerance and endurance improve throughout the program. Exercise sessions will be done for 3 sessions per week.
| Study group | Role | What they receive |
|---|---|---|
| Group A Otago exercises | Experimental | It comprises 12 balance exercises and 5 strengthening exercises. The exercises are to be done by participants three times a week. Exercises can be advanced by adding weight or repetitions, contingent on the person's strength and range of motion (weighted ankle cuffs can be utilized and modified during the program). Receives: Procedure: otago exercises; Device: virtual reality |
| Group B Virtual reality | Experimental | Participants in this group will receive virtual realityBegin with 20-30 minutes per session and extend to 30-45 minutes as tolerance and endurance improve throughout the program. Exercise sessions will be done for 3 sessions per week. Receives: Procedure: otago exercises; Device: virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance scale
It is a 14-item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait. A score of 56 indicates functional balance. A score of < 45 indicates individuals may be at greater risk of falling. A score of ≤49 indicates a risk of falls in individuals with stroke
Measured: 12 weeks
Time Up and Go test
The patient starts in a seated position. The patient stands up upon therapist's command: walks 3 meters, turns around, walks back to the chair and sits down. The time stops when the patient is seated. An older adult who takes ≥12 seconds to complete the TUG is at risk for falling. In Parkinson's, the patient is at high risk of fall if he takes more than 11.5 seconds. High test-retest reliability in patients with Parkinson's Disease (ICC= 0.80).
Measured: 12 weeks
Unified Parkinson Disease Rating Scale (Activities of Daily Living)
This part consist of 13 items speech, salivation, swallowing, handwriting, cutting food and handling utensils, dressing, hygiene, turning in bed and changing clothes, falling, freezing while walking, walking, tremor, sensory complains related to parkinsonism. Score ranging from 0-4, higher the score more will be severity.
Measured: 12 weeks
Secondary outcomes (1)
mini mental scale
The MMSE includes tasks that measure various cognitive domains such as orientation, memory, attention, calculation, language, and visuospatial abilities. Typically, the exam takes about 10 minutes to administer and consists of a series of questions and simple tasks. Scoring ranges from 0 to 30, with lower scores indicating greater cognitive impairment. It is commonly used in diagnosing and tracking conditions like dementia and Alzheimer's disease
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start1 Oct 2024
- Primary completion2 May 2025 (estimated)
- Study completion2 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sabiha Arshad, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06838741
- Sponsor's protocol ID
- REC/RCR&AHS/24/0251
- Status last verified
- Feb 2025
- First submitted
- 1 Jan 2025
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yu X, Wu X, Hou G, Han P, Jiang L, Guo Q. The Impact of Tai Chi on Motor Function, Balance, and Quality of Life in Parkinson's Disease: A Systematic Review and Meta-Analysis. Evid Based Complement Alternat Med. 2021 Jan 11;2021:6637612. doi: 10.1155/2021/6637612. eCollection 2021.
PubMed 33505498Bloem BR, Okun MS, Klein C. Parkinson's disease. Lancet. 2021 Jun 12;397(10291):2284-2303. doi: 10.1016/S0140-6736(21)00218-X. Epub 2021 Apr 10.
PubMed 33848468Chua LK, Chung YC, Bellard D, Swan L, Gobreial N, Romano A, Glatt R, Bonaguidi MA, Lee DJ, Jin Y, Liu CY, Fisher BE. Gamified Dual-Task Training for Individuals with Parkinson Disease: An Exploratory Study on Feasibility, Safety, and Efficacy. Int J Environ Res Public Health. 2021 Nov 25;18(23):12384. doi: 10.3390/ijerph182312384.
PubMed 34886114Balestrino R, Schapira AHV. Parkinson disease. Eur J Neurol. 2020 Jan;27(1):27-42. doi: 10.1111/ene.14108. Epub 2019 Nov 27.
PubMed 31631455Simon DK, Tanner CM, Brundin P. Parkinson Disease Epidemiology, Pathology, Genetics, and Pathophysiology. Clin Geriatr Med. 2020 Feb;36(1):1-12. doi: 10.1016/j.cger.2019.08.002. Epub 2019 Aug 24.
PubMed 31733690
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effects of Virtual Reality and Otago Exercises on Balance, Gait and Activities of Daily Living in Parkinson's Disease Patients.
- ClinicalTrials.gov ID
- NCT06838741
- Acronym / sponsor ID
- REC/RCR&AHS/24/0251
- Conditions
- Parkinson Disease
- Keywords
- Activities of daily living, Balance, gait, otago exercises, Parkinsons disease, Virtual reality
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 2 May 2025 (estimated)
- Study completion
- 2 May 2025 (estimated)
- First posted
- 21 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Parkinson's disease, the second most common neurological condition, significantly affects motor function, gait, balance, and daily living activities. There is a pressing need for advanced therapies that specifically address these challenges. This study explores the potential benefits of virtual reality and Otago exercises, which may enhance balance and gait by providing sensory feedback crucial for motor learning and relearning. The randomized clinical trial will enroll 74 participants with Parkinson's disease, selected through non-probability convenience sampling. After obtaining synopsis approval, participants will be randomly assigned to one of two groups: Group A will engage in Otago exercises, while Group B will participate in virtual reality sessions. Each treatment session will last for 25 minutes. To evaluate outcomes, various tools will be employed, including the Berg Balance Scale for static balance and the Timed Up and Go test for dynamic balance. The 6-Minute Walk Test will measure gait performance, and the Unified Parkinson Disease Rating Scale will assess activities of daily living. Data normality will be determined using the Kolmogorov-Smirnov test, with subsequent analyses employing either one-way ANOVA or the Kruskal-Wallis test, depending on data distribution, to draw meaningful conclusions regarding treatment efficacy.
Detailed description
The second most prevalent neurological condition is Parkinson disease. It impairs motor function, gait, balance, and daily living tasks. More advanced therapies that target balance, gait, and activities of daily living are required. Virtual reality helps in cognitive and motor improvement by creating a virtual environment. While otago exercise helps to improve balance and coordination and reduce the risk of falls in Parkinson patients. Virtual reality and otago exercises may help to improve balance and gait by providing sensory feedback that will help in motor learning and relearning. This study will compare the effects of virtual reality and otago exercises on balance, gait, and activities of daily living in patients with Parkinson's disease.
This randomized clinical trial will be carried out in a study setting 10 months after the approval of synopsis. In this study, 74 participants who will meet inclusion criteria through a non-probability convenience sampling technique will be included. Participants will be randomly assigned into 2 groups using online research randomizer software. Group A and Group B participants will receive Otago exercises and virtual reality, respectively. Total treatment time will be 25 minutes. The outcome measuring tools used will be Berg balance scale for static balance and time-up and go to measure dynamic balance; a 6-minute walk test will be used for gait, and Unified Parkinson disease Rating scale for activities of daily living. Kolmogorv-Smirnov test will be used to check normality of data. If data will be normally distributed, a one-way ANOVA will be used, and for non-parametric data, the Kruskal-Wallis test will be used.
Type (Exercises):
Weeks 1-2: Foundation and Familiarization Balance Exercises: Start with basic static balance tasks (e.g., standing on one leg, weight shifting) within a VR environment.
Gait preparation: introduce walking simulations on level ground to familiarize participants with VR-based gait training.
ADL Simulation: Initiate simple ADL tasks in VR, such as reaching for objects or virtual button pressing.
Weeks 3-4: Balance and Coordination Development
- Dynamic Balance: Progress to dynamic balance exercises (e.g., stepping over virtual obstacles, balancing on unstable surfaces in VR).
- Coordination Training: Incorporate dual-task activities where participants perform balance exercises while engaging in cognitive tasks within the VR environment.
- Functional ADLs:
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A Otago exercises | Experimental | Procedure: otago exercises, Device: virtual realityIt comprises 12 balance exercises and 5 strengthening exercises. The exercises are to be done by participants three times a week. Exercises can be advanced by adding weight or repetitions, contingent on the person's strength and range of motion (weighted ankle cuffs can be utilized and modified during the program). |
| Group B Virtual reality | Experimental | Procedure: otago exercises, Device: virtual realityParticipants in this group will receive virtual realityBegin with 20-30 minutes per session and extend to 30-45 minutes as tolerance and endurance improve throughout the program. Exercise sessions will be done for 3 sessions per week. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The age group of 50 to 70 years will be included (19).
- Both male and female (20) .
- Patients diagnosed with Parkinson's disease of Hoehn and Yahr stage (1-3)
- Patient should be able to stand 10 minutes at least without assistance.
- Patients should be able to walk with or without assistance.
Key exclusion criteria (4 listed)
- Recent surgery or any fracture.
- Any visual and hearing impairments.
- Any pathology that may impair therapy
- Joint pain or musculoskeletal problem that interfered with therapy (22).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| otago exercisesA walking program is given to participants, with the goal of including two 30-minute walking sessions each week (which can be divided into shorter segments, like three ten-minute blocks). Exercises Start exercises with 10 repetition maximum STRENGTH Knee extensor Hold for 3-5 seconds Knee flexor Hold for 3-5 seconds Hip adductor Hold for 3-5 seconds Ankle planter-flexion Calf raises Ankle dorsiflexion Toe raise BALANCE Knee bends Backwards walking Upto 30 minutes Walking and turning around 5-10 minutes Sideways walking Tandem stance Heel to toe stand Tandem walk One leg stand Heel walking Toe walk Heel toe walking backwards Sit to stand Stair walking | Procedure or surgery | Group A Otago exercises, Group B Virtual reality |
| virtual realityBegin with 20-30 minutes per session and extend to 30-45 minutes as tolerance and endurance improve throughout the program. Exercise sessions will be done for 3 sessions per week. | Device | Group A Otago exercises, Group B Virtual reality |
Primary outcome
Berg Balance scale
Time frame: 12 weeks
It is a 14-item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait. A score of 56 indicates functional balance. A score of < 45 indicates individuals may be at greater risk of falling. A score of ≤49 indicates a risk of falls in individuals with stroke
Time Up and Go test
Time frame: 12 weeks
The patient starts in a seated position. The patient stands up upon therapist's command: walks 3 meters, turns around, walks back to the chair and sits down. The time stops when the patient is seated. An older adult who takes ≥12 seconds to complete the TUG is at risk for falling. In Parkinson's, the patient is at high risk of fall if he takes more than 11.5 seconds. High test-retest reliability in patients with Parkinson's Disease (ICC= 0.80).
Unified Parkinson Disease Rating Scale (Activities of Daily Living)
Time frame: 12 weeks
This part consist of 13 items speech, salivation, swallowing, handwriting, cutting food and handling utensils, dressing, hygiene, turning in bed and changing clothes, falling, freezing while walking, walking, tremor, sensory complains related to parkinsonism. Score ranging from 0-4, higher the score more will be severity.
1 secondary outcome
mini mental scale
Time frame: 10 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Background: PubMed 33505498Yu X, Wu X, Hou G, Han P, Jiang L, Guo Q. The Impact of Tai Chi on Motor Function, Balance, and Quality of Life in Parkinson's Disease: A Systematic Review and Meta-Analysis. Evid Based Complement Alternat Med. 2021 Jan 11;2021:6637612. doi: 10.1155/2021/6637612. eCollection 2021.
- Background: PubMed 33848468Bloem BR, Okun MS, Klein C. Parkinson's disease. Lancet. 2021 Jun 12;397(10291):2284-2303. doi: 10.1016/S0140-6736(21)00218-X. Epub 2021 Apr 10.
- Background: PubMed 34886114Chua LK, Chung YC, Bellard D, Swan L, Gobreial N, Romano A, Glatt R, Bonaguidi MA, Lee DJ, Jin Y, Liu CY, Fisher BE. Gamified Dual-Task Training for Individuals with Parkinson Disease: An Exploratory Study on Feasibility, Safety, and Efficacy. Int J Environ Res Public Health. 2021 Nov 25;18(23):12384. doi: 10.3390/ijerph182312384.
- Background: PubMed 31631455Balestrino R, Schapira AHV. Parkinson disease. Eur J Neurol. 2020 Jan;27(1):27-42. doi: 10.1111/ene.14108. Epub 2019 Nov 27.
- Background: PubMed 31733690Simon DK, Tanner CM, Brundin P. Parkinson Disease Epidemiology, Pathology, Genetics, and Pathophysiology. Clin Geriatr Med. 2020 Feb;36(1):1-12. doi: 10.1016/j.cger.2019.08.002. Epub 2019 Aug 24.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sabiha Arshad, MS principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing otago exercises and virtual reality in people with Parkinson Disease, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance scale (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06838741, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.