Parkinson DiseasePhase 1NCT03835611
Evaluating Effect of Cognitive Game Based Treadmill Exercise Program in Parkinson Disease
A Phase 1 study testing Game based treadmill Platform in people with Parkinson Disease, run by University of Manitoba at 1 site in Canada.
Trial summary
An inexpensive dual-task gait training protocol has been developed for people with PD namely game based treadmill platform. A feasibility randomized trial clinical trail will be conducted to evaluate the feasibility, acceptability and estimate treatment effect size of the treatment protocol to conduct a future RCT. Read more about this study
- Who is it for?
- Ages 55 to 70 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Game based treadmill Platform
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2019to 1 Aug 2019
- Phase
- Phase 1
- 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
- Age range 55-70
- Diagnosed with PD according to UK brain bank criteria,
- PD stage 1-3 on Hoehn and Yahr scale,
- On stable medications for PD from past 3months,
- Able to walk 50m independently,
- Montreal Cognitive Assessment( MoCA) score of more than 21(Non-Dementia PD).
Who cannot join
- Any other neurodegenerative condition,
- Any orthopedic or cardiovascular impairment limiting independent walking for a minimum of 10 minutes.
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
Official title: Evaluating the Use of a Cognitive Game-Based Treadmill Exercise Program to Improve Balance and Gait in People With Parkinson Disease: A Feasibility Randomized Controlled Trial
An inexpensive dual-task gait training protocol has been developed for people with PD namely game based treadmill platform. A feasibility randomized trial clinical trail will be conducted to evaluate the feasibility, acceptability and estimate treatment effect size of the treatment protocol to conduct a future RCT.
Read the detailed description
Parkinson's disease (PD) is the second most commonly occurring neurological disorder in Canada, affecting approximately 99,000 individuals, and the number is expected to grow to 140,000 individuals by the year 2025. The hallmark of PD pathology is a progressive degeneration of dopaminergic neurons in the basal ganglia (BG). Therefore, there is a significant deterioration of balance and gait function, and especially when concurrently performing a cognitive task (dual-task walking). Fifty percent of individuals with PD also show deficiencies in one or more cognitive area. In addition, up to 80% of PD patients eventually develop dementia. Over 60% of PD, individuals fall each year and a significant portion of those who fall will experience multiple falls. Most falls occur during walking, and the consequences of these falls are often severe, leading to disability, loss of independence (i.e. safe community ambulation). For individuals with PD, community ambulation is strongly associated with the preservation of skills for independent living, leisure/recreational activities, social participation and healthy aging. Daily activities afford numerous situations in which walking must be combined with a cognitive task, such as, navigation, negotiating terrains and obstacles, tracking visual targets, reading, and recall. Walking and cognitive abilities are closely linked, and several studies have demonstrated that walking while performing various cognitive tasks (dual-task walking) results in greater gait disturbances, threats to stability and provokes freezing of gait in PD.
Numerous studies have shown that modest levels of physical activity and targeted physical therapy improves muscle strength, balance, mobility and reduces the risk of falls among older adults. Several studies have also shown improved cognitive function with physical activity, and others report that interventions that enhance cognitive skills led to improvements in fall risk. Because physical and executive cognitive decline both contribute to mobility limitations and an increased fall risk with age, several PD researchers and clinicians have developed balance-walking programs augmented with interactive cognitive activities (Dual-task training). Maximizing participation is also seen as a main goal of interventions. Long-term exercise/training programs are often fraught with low compliance and adherence. An emerging methodology is to combine exercise and activities with computer games, making the training experience more engaging and enjoyable. This approach can be an important tool for rehabilitation because it has the potential to increase participation and exercise adherence. Importantly digital media in the form of computer games can also challenge and train many different aspects of executive cognitive function. For example, many computer games are now readily available in which processing speed, cognitive inhibition, task switching, working memory and problem solving are the main components of the interactive game events.
Based on this information, investigators have has developed and validated an engaging, game-based treadmill platform (GTP), which provides an integrated approach to treat and assess the decline in balance, mobility, Visuomotor and visuospatial executive cognitive function. The GTP consists of 1) a standard treadmill instrumented with a pressure mapping system which to compute several spatiotemporal gait variables and gait stability measures; 2) an innovative interactive computer game subsystem for dual-tasking; and 3) an automated monitoring application which uses advanced data logging and analysis method to record the client's actions and choices while walking and playing targeted cognitive games. Therefore, physical and cognitive performance during exercise can be monitored synchronously and quantified electronically. Proof of principle has been established for the use of the GTP in assessment and treatment of older adult's age70-80 with fall history.
Purpose of this exploratory study is to assess the potential for successful implementation of the novel intervention, predict the feasibility and acceptability of the dual-task exercise program and identify unpredicted harm.
- Conditions
- Parkinson Disease
- Being tested
- Game based treadmill Platform, Control Group
- Keywords
- Parkinson Disease,, Balance, Gait, Dual Task walking, Feasibility
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Game based treadmill PlatformOther
The protocol for the intervention group will be:
- Warm up exercised consisting of rhythmical large movements (10minutes)
- Dynamic standing balance training by playing commercial games with head rotations while standing on a compliant surface to increase balance demands. (10 Minutes)
- DT treadmill training, consisting of playing commercial computer games while walking on the treadmill at a self-selected comfortable speed. Participants will be allowed to take rest when required and total effective DT treadmill walking will be for 30minutes. Treadmill speed will be aimed to progress depending on participant performance and documented. An overhead safety harness will always be provided to participants while walking on the treadmill. (25minutes)
Control GroupOther
- Warm-up exercise consisting of rhythmical large movements (10 minutes).
- Core standing balance exercises on a sponge surface (10 minutes).
- Treadmill walking for 20 minutes, which includes rests periods... An overhead safety harness will be provided to participants while walking on the treadmill
- Overground walking in an obstacle course. Participants will be instructed to walk along a curved path (marked by tape) and avoid obstacles placed randomly. The obstacle will be thin sponge pads with 10-12 inches in diameter (15minutes).
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Intervention Group: Participants in the intervention group will receive DT TT with GTP. GTP consists of standard treadmill nested with a pressure mapping system and an interactive computer game based sub-station in front of the treadmill. A miniature motion mouse with inbuilt sensors that enables "real-time" movements to be translated in computer sub-station by standard USB will be used. This miniature mouse will be secured to a helmet that participants will wear while walking on the treadmill to interact with computer sub-station. Participants will be expected to play commercial computer games while standing on compliant surface or walking on the treadmill. The motion mouse will help participants to control computer games hand free. Receives: Other: Game based treadmill Platform |
| Control Group | Active comparator | Control group: Participants in the control group will undergo a mixture of current gait training programs available for people with Parkinson Disease. The protocol will be: Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention to GTP
Percentage of participants adhering to 10 Weeks of GTP protocol.
Measured: 1 year
Secondary outcomes (1)
Sample size calculation
Power calculation will be done with coefficient of variation of step length during DT walking as primary outcome measure.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start1 Mar 2019
- Primary completion1 Jul 2019
- Study completion1 Aug 2019
Why it stopped: Lack of Recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03835611
- Sponsor's protocol ID
- H2018:338
- Status last verified
- Jan 2019
- First submitted
- 18 Jan 2019
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No discussion yet.
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
- Evaluating the Use of a Cognitive Game-Based Treadmill Exercise Program to Improve Balance and Gait in People With Parkinson Disease: A Feasibility Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03835611
- Acronym / sponsor ID
- H2018:338
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease,, Balance, Gait, Dual Task walking, Feasibility
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of Recruitment
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 8 Feb 2019 (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.
An inexpensive dual-task gait training protocol has been developed for people with PD namely game based treadmill platform. A feasibility randomized trial clinical trail will be conducted to evaluate the feasibility, acceptability and estimate treatment effect size of the treatment protocol to conduct a future RCT.
Detailed description
Parkinson's disease (PD) is the second most commonly occurring neurological disorder in Canada, affecting approximately 99,000 individuals, and the number is expected to grow to 140,000 individuals by the year 2025. The hallmark of PD pathology is a progressive degeneration of dopaminergic neurons in the basal ganglia (BG). Therefore, there is a significant deterioration of balance and gait function, and especially when concurrently performing a cognitive task (dual-task walking). Fifty percent of individuals with PD also show deficiencies in one or more cognitive area. In addition, up to 80% of PD patients eventually develop dementia. Over 60% of PD, individuals fall each year and a significant portion of those who fall will experience multiple falls. Most falls occur during walking, and the consequences of these falls are often severe, leading to disability, loss of independence (i.e. safe community ambulation). For individuals with PD, community ambulation is strongly associated with the preservation of skills for independent living, leisure/recreational activities, social participation and healthy aging. Daily activities afford numerous situations in which walking must be combined with a cognitive task, such as, navigation, negotiating terrains and obstacles, tracking visual targets, reading, and recall. Walking and cognitive abilities are closely linked, and several studies have demonstrated that walking while performing various cognitive tasks (dual-task walking) results in greater gait disturbances, threats to stability and provokes freezing of gait in PD.
Numerous studies have shown that modest levels of physical activity and targeted physical therapy improves muscle strength, balance, mobility and reduces the risk of falls among older adults. Several studies have also shown improved cognitive function with physical activity, and others report that interventions that enhance cognitive skills led to improvements in fall risk. Because physical and executive cognitive decline both contribute to mobility limitations and an increased fall risk with age, several PD researchers and clinicians have developed balance-walking programs augmented with interactive cognitive activities (Dual-task training). Maximizing participation is also seen as a main goal of interventions. Long-term exercise/training programs are often fraught with low compliance and adherence. An emerging methodology is to combine exercise and activities with computer games, making the training experience more engaging and enjoyable. This approach can be an important tool for rehabilitation because it has the potential to increase participation and exercise adherence. Importantly digital media in the form of computer games can also challenge and train many different aspects of executive cognitive function. For example, many computer games are now readily available in which processing speed, cognitive inhibition, task switching, working memory and problem solving are the main components of the interactive game events.
Based on this information, investigators have has developed and validated an engaging, game-based treadmill platform (GTP), which provides an integrated approach to treat and assess the decline in balance, mobility, Visuomotor and visuospatial executive cognitive function. The GTP consists of 1) a standard treadmill instrumented with a pressure mapping system which to compute several spatiotemporal gait variables and gait stability measures; 2) an innovative interactive computer game subsystem for dual-tasking; and 3) an automated monitoring application which uses advanced data logging and analysis method to record the client's actions and choices while walking and playing targeted cognitive games. Therefore, physical and cognitive performance during exercise can be monitored synchronously and quantified electronically. Proof of principle has been established for the use of the GTP in assessment and treatment of older adult's age70-80 with fall history.
Purpose of this exploratory study is to assess the potential for successful implementation of the novel intervention, predict the feasibility and acceptability of the dual-task exercise program and identify unpredicted harm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Game based treadmill PlatformIntervention Group: Participants in the intervention group will receive DT TT with GTP. GTP consists of standard treadmill nested with a pressure mapping system and an interactive computer game based sub-station in front of the treadmill. A miniature motion mouse with inbuilt sensors that enables "real-time" movements to be translated in computer sub-station by standard USB will be used. This miniature mouse will be secured to a helmet that participants will wear while walking on the treadmill to interact with computer sub-station. Participants will be expected to play commercial computer games while standing on compliant surface or walking on the treadmill. The motion mouse will help participants to control computer games hand free. |
| Control Group | Active comparator | Other: Control GroupControl group: Participants in the control group will undergo a mixture of current gait training programs available for people with Parkinson Disease. The protocol will be: |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age range 55-70
- Diagnosed with PD according to UK brain bank criteria,
- PD stage 1-3 on Hoehn and Yahr scale,
- On stable medications for PD from past 3months,
- Able to walk 50m independently,
Key exclusion criteria (2 listed)
- Any other neurodegenerative condition,
- Any orthopedic or cardiovascular impairment limiting independent walking for a minimum of 10 minutes.
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 |
|---|---|---|
| Game based treadmill PlatformThe protocol for the intervention group will be: * Warm up exercised consisting of rhythmical large movements (10minutes) * Dynamic standing balance training by playing commercial games with head rotations while standing on a compliant surface to increase balance demands. (10 Minutes) * DT treadmill training, consisting of playing commercial computer games while walking on the treadmill at a self-selected comfortable speed. Participants will be allowed to take rest when required and total effective DT treadmill walking will be for 30minutes. Treadmill speed will be aimed to progress depending on participant performance and documented. An overhead safety harness will always be provided to participants while walking on the treadmill. (25minutes) | Other | Intervention group |
| Control Group* Warm-up exercise consisting of rhythmical large movements (10 minutes). * Core standing balance exercises on a sponge surface (10 minutes). * Treadmill walking for 20 minutes, which includes rests periods... An overhead safety harness will be provided to participants while walking on the treadmill * Overground walking in an obstacle course. Participants will be instructed to walk along a curved path (marked by tape) and avoid obstacles placed randomly. The obstacle will be thin sponge pads with 10-12 inches in diameter (15minutes). | Other | Control Group |
Primary outcome
Retention to GTP
Time frame: 1 year
Percentage of participants adhering to 10 Weeks of GTP protocol.
1 secondary outcome
Sample size calculation
Time frame: 1 Year
Results and safety
The study was stopped early (reason given: Lack of Recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Individual participant dataSharing planned: Undecided. No discussion yet.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Game based treadmill Platform in people with Parkinson Disease, 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 6 inclusion and 2 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: stopped early, 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of Recruitment). Results are not available in the source record.
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?
Retention to GTP (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.