Parkinson DiseaseNCT03232996
Evaluation of a Computer Game Based Rehabilitation System for Assessment and Treatment of Balance and Gait Impairments in Individuals With Parkinson's Disease.
A study testing Computer game based balance and walking rehabilitation for individuals with Parkinson's Disease in people with Parkinson Disease and Parkinson, run by University of Manitoba at 1 site in Canada.
Trial summary
Examining the feasibility and acceptability of the computer game based rehabilitation system for improving balance, gait and executive function in individuals with PD. This will involve a pilot case series intervention study of individuals with PD will be conducted. Read more about this study
- Who is it for?
- Ages 55 to 70 years
- Conditions the study is for
- Parkinson Disease, Parkinson
- What is being tested?
- Computer game based balance and walking rehabilitation for individuals with Parkinson's Disease
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2017to 1 Aug 2019
- 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 55 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with idiopathic PD, defined by the UK Brain Bank criterion
- In disease stage 2 - 3 (classified by Hoehn and Yahr scale)
- Montreal cognitive assessment (MoCA) scores to be 25 or higher
- Able to walk at least 50 meters without any assistance.
Who cannot join
- Any psychiatric co-morbidity
- Clinically diagnosed dementia or any clinically significant cognitive impairments.
- History of neurological disorder other than PD, which could affect the performance of the participant
- Orthopedic disorders which can affect gait or balance for the participant
- Any unstable medical condition which majorly includes cardiovascular impairments.
Trial locations and contacts
1 site in 1 country.
Canada1 site
College of Rehabilitation Sciences, University of Manitoba
Winnipeg, Manitoba, R3E 0T6
About this study
Examining the feasibility and acceptability of the computer game based rehabilitation system for improving balance, gait and executive function in individuals with PD. This will involve a pilot case series intervention study of individuals with PD will be conducted.
Read the detailed description
This research study will involve a case series pilot study of individuals with PD. Conventional therapy programs for PD population target motor and cognitive deficits in isolation. Recently there has been a growing interest in the application of digital media in rehabilitation. Exergaming and the use of cognitive games have shown good results in patients with Traumatic brain injury, Cerebral palsy, stroke rehabilitation and geriatric population for mobility limitations and dementia.
All the 30 participants from the previous objective will be requested to take part in our objective 2. Objective 2 research protocol will be an 8- week (twice per week) training program of DT balance and DT walking exercises.
Each session will be 45 minutes long. A basic computer game based exercise program will be designed for each participant depending upon their functional status. Every Participant will receive orientation and training about CGBRS, motion mouse and video-games. For initial sessions, relatively slow and large target movements will be selected for the computer games. Game speed, amplitude, mouse sensitivity, and difficulty will be progressed as tolerated for each participant.
Participants will be asked to stand on a stationary treadmill, in front of a LED monitor which will be placed 1 meter away from the treadmill. The treadmill has front and side hand rails so is a convenient place to perform the DT balance activities. The participants will also be fitted with a safety harness. The participants will be asked to wear a head band which is instrumented with the motion sense mouse. Thus, hands-free head rotations will be used to interact with the computer games selected for the DT rehabilitation program. Six to eight computer games will be selected for each participant from a collection of over 60 purchased from Big Fish Games (www.bigfishgames.com). The computer games involve goal-directed visuospatial executive cognitive activities including visual search and tracking of multiple targets, movements of different speeds to interact with game targets with varying movement precision, the presence of distracters, matching and puzzle game.
Participants will play the computer games under the following conditions: -
- While standing on a fixed surface (warm -up duration for 5 minutes)
- While Standing on a compliant sponge pad to increase balance demands (duration - 10 minutes)
- While walking on a treadmill at a predetermined comfortable speed for an interval of 2-3 minutes with 1-2 min rest periods (duration of the treadmill walking component will be 20 minutes.
- Conditions
- Parkinson Disease, Parkinson
- Being tested
- Computer game based balance and walking rehabilitation for individuals with Parkinson's Disease
- Keywords
- Balance, Gait
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer game based balance and walking rehabilitation for individuals with Parkinson's DiseaseOther
All the participants will take part in an 8 week (twice per week) computer game based exercise program for dual task balance and dual task walk training. Participants will be standing in front of LED monitor. They will be asked to wear a head band which will be instrumented with motion sense mouse. Thus, hands-free head rotations will be used to interact with the computer games selected for the DT rehabilitation program. Participants will play few interactive computer games during - Normal standing (fixed surface), Standing on a compliant sponge pad and then while walking on a treadmill.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Computer Game based balance and walk rehabilitation Receives: Other: Computer game based balance and walking rehabilitation for individuals with Parkinson's Disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic Standing Balance
The following tasks will be performed for 45 seconds while standing on a sponge pad; a) eyes open (EO), i.e. single task balance condition, and then b) performing the computer gaming activities (i.e. DT balance conditions). A force sensor array (FSA) pressure-sensing mat (Vista Medical Ltd., Manitoba, Canada) will be used to record vertical foot pressures and thus to compute center of foot pressure (COP) migration.
Measured: Change from baseline Dynamic standing balance at 8 weeks
Gait Assessment
The participant will first be asked to walk on the treadmill at his/her comfortable speed for 3 minutes to acclimate with the treadmill prior to testing. After a rest period of 2 minutes they will be asked to walk for 1 minute under the following conditions; a) walk only or single task condition and b) walking while performing the computer gaming tasks (DT walking condition). The treadmill instrumented with a pressure mat (Vista Medical, CA) will be used to record vertical foot contact forces and used to compute spatial-temporal gait variables. Participants walked for 5 minutes to acclimate to the treadmill prior to testing.
Measured: Change from baseline spatio-temporal gait variables at 8 weeks.
Secondary outcomes (1)
Unified Parkinson Disease Rating Scale (UPDRS)
UPDRS is the most common rating scale used to observe and quantify disability and impairment in Parkinson's Disease. This is a 5 point rating scale (from 0 to 5) which is assessed in an ordinal level. 0 describes absence or least severity while 4 describes the highest severity. Increase in severity is denoted with higher scores. Scores will be computed for behavior (part 1), Activites of Daily living (part 2) and Motor (part 3) sections. Scores of all the three section will be added and computed as the "Final UPDRS scores" for our clinical trial
Measured: Change from baseline "Final UPDRS scores" at 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2017
- Study start1 Nov 2017
- Primary completion30 Apr 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tony Szturm, Ph.D., Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03232996
- Sponsor's protocol ID
- H2017:225
- Status last verified
- Oct 2018
- First submitted
- 24 Jul 2017
- Last updated
- 25 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bhatt M, Mahana B, Ko JH, Kolesar TA, Kanitkar A, Szturm T. Computerized Dual-Task Testing of Gait Visuomotor and Cognitive Functions in Parkinson's Disease: Test-Retest Reliability and Validity. Front Hum Neurosci. 2021 Jul 15;15:706230. doi: 10.3389/fnhum.2021.706230. eCollection 2021.
PubMed 34335213
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Computer Game Based Rehabilitation System for Assessment and Treatment of Balance and Gait Impairments in Individuals With Parkinson's Disease.
- ClinicalTrials.gov ID
- NCT03232996
- Acronym / sponsor ID
- H2017:225
- Conditions
- Parkinson Disease, Parkinson
- Keywords
- Balance, Gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 28 Jul 2017 (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.
Examining the feasibility and acceptability of the computer game based rehabilitation system for improving balance, gait and executive function in individuals with PD. This will involve a pilot case series intervention study of individuals with PD will be conducted.
Detailed description
This research study will involve a case series pilot study of individuals with PD. Conventional therapy programs for PD population target motor and cognitive deficits in isolation. Recently there has been a growing interest in the application of digital media in rehabilitation. Exergaming and the use of cognitive games have shown good results in patients with Traumatic brain injury, Cerebral palsy, stroke rehabilitation and geriatric population for mobility limitations and dementia.
All the 30 participants from the previous objective will be requested to take part in our objective 2. Objective 2 research protocol will be an 8- week (twice per week) training program of DT balance and DT walking exercises.
Each session will be 45 minutes long. A basic computer game based exercise program will be designed for each participant depending upon their functional status. Every Participant will receive orientation and training about CGBRS, motion mouse and video-games. For initial sessions, relatively slow and large target movements will be selected for the computer games. Game speed, amplitude, mouse sensitivity, and difficulty will be progressed as tolerated for each participant.
Participants will be asked to stand on a stationary treadmill, in front of a LED monitor which will be placed 1 meter away from the treadmill. The treadmill has front and side hand rails so is a convenient place to perform the DT balance activities. The participants will also be fitted with a safety harness. The participants will be asked to wear a head band which is instrumented with the motion sense mouse. Thus, hands-free head rotations will be used to interact with the computer games selected for the DT rehabilitation program. Six to eight computer games will be selected for each participant from a collection of over 60 purchased from Big Fish Games (www.bigfishgames.com). The computer games involve goal-directed visuospatial executive cognitive activities including visual search and tracking of multiple targets, movements of different speeds to interact with game targets with varying movement precision, the presence of distracters, matching and puzzle game.
Participants will play the computer games under the following conditions: -
- While standing on a fixed surface (warm -up duration for 5 minutes)
- While Standing on a compliant sponge pad to increase balance demands (duration - 10 minutes)
- While walking on a treadmill at a predetermined comfortable speed for an interval of 2-3 minutes with 1-2 min rest periods (duration of the treadmill walking component will be 20 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Computer game based balance and walking rehabilitation for individuals with Parkinson's DiseaseComputer Game based balance and walk rehabilitation |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with idiopathic PD, defined by the UK Brain Bank criterion
- In disease stage 2 - 3 (classified by Hoehn and Yahr scale)
- Montreal cognitive assessment (MoCA) scores to be 25 or higher
- Able to walk at least 50 meters without any assistance.
Key exclusion criteria (5 listed)
- Any psychiatric co-morbidity
- Clinically diagnosed dementia or any clinically significant cognitive impairments.
- History of neurological disorder other than PD, which could affect the performance of the participant
- Orthopedic disorders which can affect gait or balance for the participant
- Any unstable medical condition which majorly includes cardiovascular impairments.
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 |
|---|---|---|
| Computer game based balance and walking rehabilitation for individuals with Parkinson's DiseaseAll the participants will take part in an 8 week (twice per week) computer game based exercise program for dual task balance and dual task walk training. Participants will be standing in front of LED monitor. They will be asked to wear a head band which will be instrumented with motion sense mouse. Thus, hands-free head rotations will be used to interact with the computer games selected for the DT rehabilitation program. Participants will play few interactive computer games during - Normal standing (fixed surface), Standing on a compliant sponge pad and then while walking on a treadmill. | Other | Experimental Group |
Primary outcome
Dynamic Standing Balance
Time frame: Change from baseline Dynamic standing balance at 8 weeks
The following tasks will be performed for 45 seconds while standing on a sponge pad; a) eyes open (EO), i.e. single task balance condition, and then b) performing the computer gaming activities (i.e. DT balance conditions). A force sensor array (FSA) pressure-sensing mat (Vista Medical Ltd., Manitoba, Canada) will be used to record vertical foot pressures and thus to compute center of foot pressure (COP) migration.
Gait Assessment
Time frame: Change from baseline spatio-temporal gait variables at 8 weeks.
The participant will first be asked to walk on the treadmill at his/her comfortable speed for 3 minutes to acclimate with the treadmill prior to testing. After a rest period of 2 minutes they will be asked to walk for 1 minute under the following conditions; a) walk only or single task condition and b) walking while performing the computer gaming tasks (DT walking condition). The treadmill instrumented with a pressure mat (Vista Medical, CA) will be used to record vertical foot contact forces and used to compute spatial-temporal gait variables. Participants walked for 5 minutes to acclimate to the treadmill prior to testing.
1 secondary outcome
Unified Parkinson Disease Rating Scale (UPDRS)
Time frame: Change from baseline "Final UPDRS scores" at 8 weeks.
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 25 Mar 2020.
- Derived from this study: PubMed 34335213Bhatt M, Mahana B, Ko JH, Kolesar TA, Kanitkar A, Szturm T. Computerized Dual-Task Testing of Gait Visuomotor and Cognitive Functions in Parkinson's Disease: Test-Retest Reliability and Validity. Front Hum Neurosci. 2021 Jul 15;15:706230. doi: 10.3389/fnhum.2021.706230. eCollection 2021.
- Individual participant dataSharing planned: Undecided
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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.
Tony Szturm, Ph.D. principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer game based balance and walking rehabilitation for individuals with Parkinson's Disease in people with Parkinson Disease and Parkinson, run by University of Manitoba at 1 site in Canada.
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 4 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 25 Mar 2020. 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 Canada. 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?
Dynamic Standing Balance (time frame: Change from baseline Dynamic standing balance at 8 weeks). The study lists 2 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 NCT03232996, which also lists 1 linked publication.
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 25 Mar 2020.