Parkinson DiseaseNCT05043727
Effects of Exer Gaming on Balance and Gait in Parkinson's Patients
A study testing Exer gaming and conventional treatment plan in people with Parkinson Disease and Balance, run by Riphah International University at 1 site in Pakistan.
Trial summary
To compare the effects of exer-gaming with conventional physiotherapy on balance and gait in Parkinson's patients Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Parkinson Disease, Balance
- What is being tested?
- Exer gaming and conventional treatment plan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 sitePakistan
- Study dates
- 6 Oct 2019to 21 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed Parkinson's disease patients in stage I, II,III according to Hoeh n-Yahr classification.
- Patients with balance and gait disorders
Who cannot join
- Other neurological conditions (stroke, Alzheimer)
- Red flag signs (tumors, fractures, infections etc)
- Uncontrolled hypertension.
- Patients with visual disturbances
- Patients with cognitive disorders
Trial locations and contacts
1 site in 1 country.
About this study
To compare the effects of exer-gaming with conventional physiotherapy on balance and gait in Parkinson's patients
Read the detailed description
Parkinsons Disease is a progressive neuro degenerative disorder manifested by a broad spectrum of motor and non-motor features. Approximately 500 000 people suffer from Parkinson's Disease in the United States and there are approximately 50,000 new cases reported annually . Postural instability, impaired gait, and freezing episodes are all common occurrences in Parkinson's. Agility activities, including supine-to-stand, ambulation, turning, and reaching activities, have been used to reduce freezing episodes, particularly in the early stages of disease.
Conventional physical therapy(balance training, stretching and strengthening exercises) being used for the balance and gait training in Parkinson. In recent time, there has been development in such treatment plan. Virtual reality based games have been used for such purposes. This study will look at the effects of virtual reality gaming in patients suffering from Parkinson's disease and its outcomes in term of gait and balance training. A randomized clinical trial will be performed. total 16 patients will be included in the study and will be divided into two groups. VR Group will be receiving virtual reality based exercise plan while the CONVENTIONAL group will receive conventional physical therapy . Division will be done through lottery method. Unified parkinson's disease rating scale and dynamic gait index will be used to collect the data. Treatment frequency will be three days per week for three months .
- Conditions
- Parkinson Disease, Balance
- Being tested
- Exer gaming, conventional treatment plan
- Keywords
- Postural instability,, Parkinson Disease,, Exer Game
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exer gamingCombination product
exer gaming treatment plan will include perfect ten balance, wii skiing, wiicycling. Each Patient will receive twenty four sessions. Each treatment session was of 50 minutes with two minutes rest between each exercise.
conventional treatment planCombination product
it will receive conventional treatment plan which includes balance training, gait training, stretching and strengthening exercises.Each patient will receive twenty four sessions of conventional physical therapy. Treatment session will be of 50 minutes with 2 minutes rest period between each exercise.
| Study group | Role | What they receive |
|---|---|---|
| Exer gaming treatment plan | Experimental | Exer gaming treatment plan Receives: Combination Product: Exer gaming |
| conventional treatment plan | Active comparator | conventional treatment plan Receives: Combination Product: conventional treatment plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unified Parkinson's diseaserating scale (UPDRS)
this test is specifically used in Parkinson patients to check balance
Measured: 50 minutes
Secondary outcomes (1)
dynamic gait index.
to check dynamic balance
Measured: 50 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start6 Oct 2019
- Primary completion6 Apr 2020
- Study completion21 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Model description
- each participant will be requested to draw either number one or two from box. Group number one will receive exer gaming treatment plan Each Patient received twenty four sessions. Each treatment session will of 50 minutes with two minutes rest between each exercise. Group two will receive conventional treatment plan which will include balance training, gait training, stretching and strengthening exercises.Treatment session will be of 50 minutes with 2 minutes rest period between each exercise.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- zeest hashmi, MS NMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05043727
- Sponsor's protocol ID
- REC/Lhr/2024 Shahbaz
- Status last verified
- Sep 2021
- First submitted
- 27 Aug 2021
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liao YY, Yang YR, Cheng SJ, Wu YR, Fuh JL, Wang RY. Virtual Reality-Based Training to Improve Obstacle-Crossing Performance and Dynamic Balance in Patients With Parkinson's Disease. Neurorehabil Neural Repair. 2015 Aug;29(7):658-67. doi: 10.1177/1545968314562111. Epub 2014 Dec 24.
PubMed 25539782Goetz CG, Tilley BC, Shaftman SR, Stebbins GT, Fahn S, Martinez-Martin P, Poewe W, Sampaio C, Stern MB, Dodel R, Dubois B, Holloway R, Jankovic J, Kulisevsky J, Lang AE, Lees A, Leurgans S, LeWitt PA, Nyenhuis D, Olanow CW, Rascol O, Schrag A, Teresi JA, van Hilten JJ, LaPelle N; Movement Disorder Society UPDRS Revision Task Force. Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): scale presentation and clinimetric testing results. Mov Disord. 2008 Nov 15;23(15):2129-70. doi: 10.1002/mds.22340.
PubMed 19025984Lee RG, Tonolli I, Viallet F, Aurenty R, Massion J. Preparatory postural adjustments in parkinsonian patients with postural instability. Can J Neurol Sci. 1995 May;22(2):126-35. doi: 10.1017/s0317167100040208.
PubMed 7627914
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exer Gaming on Balance and Gait in Parkinson's Patients
- ClinicalTrials.gov ID
- NCT05043727
- Acronym / sponsor ID
- REC/Lhr/2024 Shahbaz
- Conditions
- Parkinson Disease, Balance
- Keywords
- Postural instability,, Parkinson Disease,, Exer Game
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 6 Oct 2019 (actual)
- Primary completion
- 6 Apr 2020 (actual)
- Study completion
- 21 Apr 2020 (actual)
- First posted
- 14 Sep 2021 (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.
To compare the effects of exer-gaming with conventional physiotherapy on balance and gait in Parkinson's patients
Detailed description
Parkinsons Disease is a progressive neuro degenerative disorder manifested by a broad spectrum of motor and non-motor features. Approximately 500 000 people suffer from Parkinson's Disease in the United States and there are approximately 50,000 new cases reported annually . Postural instability, impaired gait, and freezing episodes are all common occurrences in Parkinson's. Agility activities, including supine-to-stand, ambulation, turning, and reaching activities, have been used to reduce freezing episodes, particularly in the early stages of disease.
Conventional physical therapy(balance training, stretching and strengthening exercises) being used for the balance and gait training in Parkinson. In recent time, there has been development in such treatment plan. Virtual reality based games have been used for such purposes. This study will look at the effects of virtual reality gaming in patients suffering from Parkinson's disease and its outcomes in term of gait and balance training. A randomized clinical trial will be performed. total 16 patients will be included in the study and will be divided into two groups. VR Group will be receiving virtual reality based exercise plan while the CONVENTIONAL group will receive conventional physical therapy . Division will be done through lottery method. Unified parkinson's disease rating scale and dynamic gait index will be used to collect the data. Treatment frequency will be three days per week for three months .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- each participant will be requested to draw either number one or two from box. Group number one will receive exer gaming treatment plan Each Patient received twenty four sessions. Each treatment session will of 50 minutes with two minutes rest between each exercise. Group two will receive conventional treatment plan which will include balance training, gait training, stretching and strengthening exercises.Treatment session will be of 50 minutes with 2 minutes rest period between each exercise.
| Arm | Type | Receives |
|---|---|---|
| Exer gaming treatment plan | Experimental | Combination Product: Exer gamingExer gaming treatment plan |
| conventional treatment plan | Active comparator | Combination Product: conventional treatment planconventional treatment plan |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed Parkinson's disease patients in stage I, II,III according to Hoeh n-Yahr classification.
- Patients with balance and gait disorders
Key exclusion criteria (5 listed)
- Other neurological conditions (stroke, Alzheimer)
- Red flag signs (tumors, fractures, infections etc)
- Uncontrolled hypertension.
- Patients with visual disturbances
- Patients with cognitive disorders
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 |
|---|---|---|
| Exer gamingexer gaming treatment plan will include perfect ten balance, wii skiing, wiicycling. Each Patient will receive twenty four sessions. Each treatment session was of 50 minutes with two minutes rest between each exercise. | Combination product | Exer gaming treatment plan |
| conventional treatment planit will receive conventional treatment plan which includes balance training, gait training, stretching and strengthening exercises.Each patient will receive twenty four sessions of conventional physical therapy. Treatment session will be of 50 minutes with 2 minutes rest period between each exercise. | Combination product | conventional treatment plan |
Primary outcome
Unified Parkinson's diseaserating scale (UPDRS)
Time frame: 50 minutes
this test is specifically used in Parkinson patients to check balance
1 secondary outcome
dynamic gait index.
Time frame: 50 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Background: PubMed 25539782Liao YY, Yang YR, Cheng SJ, Wu YR, Fuh JL, Wang RY. Virtual Reality-Based Training to Improve Obstacle-Crossing Performance and Dynamic Balance in Patients With Parkinson's Disease. Neurorehabil Neural Repair. 2015 Aug;29(7):658-67. doi: 10.1177/1545968314562111. Epub 2014 Dec 24.
- Background: PubMed 19025984Goetz CG, Tilley BC, Shaftman SR, Stebbins GT, Fahn S, Martinez-Martin P, Poewe W, Sampaio C, Stern MB, Dodel R, Dubois B, Holloway R, Jankovic J, Kulisevsky J, Lang AE, Lees A, Leurgans S, LeWitt PA, Nyenhuis D, Olanow CW, Rascol O, Schrag A, Teresi JA, van Hilten JJ, LaPelle N; Movement Disorder Society UPDRS Revision Task Force. Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): scale presentation and clinimetric testing results. Mov Disord. 2008 Nov 15;23(15):2129-70. doi: 10.1002/mds.22340.
- Background: PubMed 7627914Lee RG, Tonolli I, Viallet F, Aurenty R, Massion J. Preparatory postural adjustments in parkinsonian patients with postural instability. Can J Neurol Sci. 1995 May;22(2):126-35. doi: 10.1017/s0317167100040208.
- 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. This study is not recruiting at the moment.
zeest hashmi, MS NMPT 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 Exer gaming and conventional treatment plan in people with Parkinson Disease and Balance, 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 14 Sep 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Unified Parkinson's diseaserating scale (UPDRS) (time frame: 50 minutes). 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 NCT05043727, which also lists 3 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 14 Sep 2021.