Parkinson DiseaseCMAGDTNCT04415775
Changes in Metabolic Activity, and Gait Function by Dual-task Cognitive Game-based Treadmill Intervention in Parkinson's Disease.
A study testing Game based treadmill Program and Conventional Gait Rehabilitation in people with Parkinson Disease, run by University of Manitoba at 1 site in Canada.
Trial summary
The present proposal will evaluate the neural underpinnings of (a) the decline of mobility function in Parkinson's disease (PD), and (b) the effects of an innovative computer-guided dual-task (DT) mobility training platform (complementary approach: exercise intervention). Read more about this study
- Who is it for?
- Ages 55 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Game based treadmill Program and Conventional Gait Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2021to 1 Nov 2023
- 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
- Healthy volunteers accepted
- 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
- Age 55-70 years
- Stable medications for Parkinson over the past 3 months
- Able to walk at least 50m without any assistive device
- Episode of FOG in the past 6 months
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- Age 55-70 years,
- Independent community living,
- Not receiving any home care or Physiotherapy,
- Walking outdoors for exercise for at least 3 times per week,
- No neurological conditions affecting mobility or affecting cognitive abilities,
- Any orthopedic impairment affecting gait and balance.
- Any cardiovascular impairment limiting the ability to walk for 10-15 minutes on a treadmill.
- Abnormal MRI and
- General contraindications for PET and MRI including severe dyskinesia, diabetes, cardiac pacemakers.
Who cannot join
- The presence of neurological conditions other than PD affecting cognitive abilities.
- Any orthopedic impairment affecting gait and balance.
- Any cardiovascular impairment limiting the ability to walk for 10-15 minutes on a treadmill;
- Abnormal MRI
- General contraindications.
- Any orthopedic impairment affecting gait and balance.
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- Any cardiovascular impairment limiting the ability to walk for 10-15 minutes on a treadmill.
- Abnormal MRI
- General contraindications.
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: Changes in Metabolic Activity, and Gait Function by Dual-task Cognitive Game-based Treadmill Intervention in Parkinson's Disease
The present proposal will evaluate the neural underpinnings of (a) the decline of mobility function in Parkinson's disease (PD), and (b) the effects of an innovative computer-guided dual-task (DT) mobility training platform (complementary approach: exercise intervention). Improved mobility functioning in PD, specifically balance, gait and cognition, directly translates to improved community ambulation as well as increased physical activity and social participation. These benefits are known to have a significant preventive and disease-modifying impact that surpasses any currently available pharmacological interventions. Outcomes of this research will provide new insights into brain plasticity mechanisms and will accelerate further optimization and commercialization of multi-modal mobility-cognitive training applications along with accompanying smart electronic monitoring tools. With wider usage of this training platform, rehabilitation specialists will be able to effectively scale services, while still monitoring quality and ensuring accountability. Thus, the study is highly transformative.
Read the detailed description
The present proposal will evaluate the neural underpinnings of (a) the decline of mobility function in Parkinson's disease (PD), and (b) the effects of an innovative computer-guided dual-task (DT) mobility training platform (complementary approach: exercise intervention). Improved mobility functioning in PD, specifically balance, gait and cognition, directly translates to improved community ambulation as well as increased physical activity and social participation. These benefits are known to have a significant preventive and disease-modifying impact that surpasses any currently available pharmacological interventions. Outcomes of this research will provide new insights into brain plasticity mechanisms and will accelerate further optimization and commercialization of multi-modal mobility-cognitive training applications along with accompanying smart electronic monitoring tools. With wider usage of this training platform, rehabilitation specialists will be able to effectively scale services, while still monitoring quality and ensuring accountability. Thus, the study is highly transformative.
The investigators propose a collaborative project between our research centers at the University of Manitoba and the University of Toronto, to further understand the neural underpinnings of cognition/gait impairment and the effects of DT training in PD.
Cutting-edge behavioural brain imaging methods will be used to identify functional brain metabolic network re-organization and the molecular basis of gait/cognitive impairment. This will be used to evaluate the neurophysiological underpinnings of the DT treadmill training effect, which has repeatedly demonstrated to be clinically effective. The possibility of detecting these changes and localizing the site(s) of brain plasticity will have important implications at several levels. These biomarkers could be used as an indicator of disease severity, outcome measures for neuroprotection studies and other treatment and lifestyle strategies.
Objective 1: To characterize the abnormal brain metabolic pattern in PD patients during DT-walking as compared to healthy age-matched controls.
Objective 2: The investigators will examine whether a 10-week treadmill walking program combined with specific cognitive activities (i.e. true DT walking training known to improve gait function and reduce falls) will "normalize" the brain abnormality (that is identified in Aim 1), or whether it will activate a novel compensatory mechanism and therefore evidence to isolate the region(s) of brain plasticity.
The hypothesis is that the DT gait-related abnormal brain metabolic pattern and abnormally elevated amyloid deposition are inter-related and that these abnormal functional connectivity patterns and structural changes are highly associated with gait, cognitive and DT walking deficits in PD. It is also hypothesized that the DT treadmill-training program will result in specific and significant changes in the DT gait-related abnormal brain metabolic pattern, in the PD participants.
- Conditions
- Parkinson Disease
- Being tested
- Game based treadmill Program, Conventional Gait Rehabilitation
- Keywords
- Dual task walking, Treadmill walking, PET scans, Parkinson Disease
- 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 ProgramOther
Participants will be expected to play several cognitive computer games while standing on a sponge pad (10-min warm-up and while walking on the treadmill at your self-selected comfortable speed. (Dual-task treadmill training). This would be done in intervals of 2-4 min with rest periods for a total time of 35 minutes Treadmill speed and the difficulty level of the cognitive games will progress depending on participant performance and comfort level.
Conventional Gait RehabilitationOther
Participants will undergo a mixture of current gait training programs available for people with Parkinson's Disease. The protocol will be a Warm-up exercise consisting of rhythmical large movements (10 minutes), as well as video game practice while standing (i.e., single-task; 10 minutes). Treadmill walking in intervals of 2-4 minutes with rest periods. Walking over the ground while negotiating through obstacles. (10 minutes) The speed of the treadmill will be progressed gradually and as tolerated.
| Study group | Role | What they receive |
|---|---|---|
| Dual-task walking Intervention | Experimental | Not described Receives: Other: Game based treadmill Program |
| Conventional Gait Rehabilitation | Active comparator | Not described Receives: Other: Conventional Gait Rehabilitation |
| Healthy Controls | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
NDWP scores
NDWP scores on PET scans of participants will be analysed to identify gait impairment related imagining signatures during single and dual-task walking, and after intervention. They will also be compared to age-matched healthy controls using student t-test.
Measured: 10 weeks
Step Length Coefficient of Variability
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start1 Jun 2021 (estimated)
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
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.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One experimental group and other control group receiving control intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Weston Brain Institute
- Responsible party
- Principal investigator, Dr. Tony Szturm, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04415775
- Sponsor's protocol ID
- B2020:043
- Acronym
- CMAGDT
- Status last verified
- May 2021
- First submitted
- 28 May 2020
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Metabolic Activity, and Gait Function by Dual-task Cognitive Game-based Treadmill Intervention in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04415775
- Acronym / sponsor ID
- CMAGDT / B2020:043
- Conditions
- Parkinson Disease
- Keywords
- Dual task walking, Treadmill walking, PET scans, Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Weston Brain Institute
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 4 Jun 2020 (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.
The present proposal will evaluate the neural underpinnings of (a) the decline of mobility function in Parkinson's disease (PD), and (b) the effects of an innovative computer-guided dual-task (DT) mobility training platform (complementary approach: exercise intervention). Improved mobility functioning in PD, specifically balance, gait and cognition, directly translates to improved community ambulation as well as increased physical activity and social participation. These benefits are known to have a significant preventive and disease-modifying impact that surpasses any currently available pharmacological interventions. Outcomes of this research will provide new insights into brain plasticity mechanisms and will accelerate further optimization and commercialization of multi-modal mobility-cognitive training applications along with accompanying smart electronic monitoring tools. With wider usage of this training platform, rehabilitation specialists will be able to effectively scale services, while still monitoring quality and ensuring accountability. Thus, the study is highly transformative.
Detailed description
The present proposal will evaluate the neural underpinnings of (a) the decline of mobility function in Parkinson's disease (PD), and (b) the effects of an innovative computer-guided dual-task (DT) mobility training platform (complementary approach: exercise intervention). Improved mobility functioning in PD, specifically balance, gait and cognition, directly translates to improved community ambulation as well as increased physical activity and social participation. These benefits are known to have a significant preventive and disease-modifying impact that surpasses any currently available pharmacological interventions. Outcomes of this research will provide new insights into brain plasticity mechanisms and will accelerate further optimization and commercialization of multi-modal mobility-cognitive training applications along with accompanying smart electronic monitoring tools. With wider usage of this training platform, rehabilitation specialists will be able to effectively scale services, while still monitoring quality and ensuring accountability. Thus, the study is highly transformative.
The investigators propose a collaborative project between our research centers at the University of Manitoba and the University of Toronto, to further understand the neural underpinnings of cognition/gait impairment and the effects of DT training in PD.
Cutting-edge behavioural brain imaging methods will be used to identify functional brain metabolic network re-organization and the molecular basis of gait/cognitive impairment. This will be used to evaluate the neurophysiological underpinnings of the DT treadmill training effect, which has repeatedly demonstrated to be clinically effective. The possibility of detecting these changes and localizing the site(s) of brain plasticity will have important implications at several levels. These biomarkers could be used as an indicator of disease severity, outcome measures for neuroprotection studies and other treatment and lifestyle strategies.
Objective 1: To characterize the abnormal brain metabolic pattern in PD patients during DT-walking as compared to healthy age-matched controls.
Objective 2: The investigators will examine whether a 10-week treadmill walking program combined with specific cognitive activities (i.e. true DT walking training known to improve gait function and reduce falls) will "normalize" the brain abnormality (that is identified in Aim 1), or whether it will activate a novel compensatory mechanism and therefore evidence to isolate the region(s) of brain plasticity.
The hypothesis is that the DT gait-related abnormal brain metabolic pattern and abnormally elevated amyloid deposition are inter-related and that these abnormal functional connectivity patterns and structural changes are highly associated with gait, cognitive and DT walking deficits in PD. It is also hypothesized that the DT treadmill-training program will result in specific and significant changes in the DT gait-related abnormal brain metabolic pattern, in the PD participants.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- One experimental group and other control group receiving control intervention.
| Arm | Type | Receives |
|---|---|---|
| Dual-task walking Intervention | Experimental | Other: Game based treadmill Program |
| Conventional Gait Rehabilitation | Active comparator | Other: Conventional Gait Rehabilitation |
| Healthy Controls | No intervention | – |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 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
- Age 55-70 years
- Stable medications for Parkinson over the past 3 months
- Able to walk at least 50m without any assistive device
Key exclusion criteria (9 listed)
- The presence of neurological conditions other than PD affecting cognitive abilities.
- Any orthopedic impairment affecting gait and balance.
- Any cardiovascular impairment limiting the ability to walk for 10-15 minutes on a treadmill;
- Abnormal MRI
- General contraindications.
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 ProgramParticipants will be expected to play several cognitive computer games while standing on a sponge pad (10-min warm-up and while walking on the treadmill at your self-selected comfortable speed. (Dual-task treadmill training). This would be done in intervals of 2-4 min with rest periods for a total time of 35 minutes Treadmill speed and the difficulty level of the cognitive games will progress depending on participant performance and comfort level. | Other | Dual-task walking Intervention |
| Conventional Gait RehabilitationParticipants will undergo a mixture of current gait training programs available for people with Parkinson's Disease. The protocol will be a Warm-up exercise consisting of rhythmical large movements (10 minutes), as well as video game practice while standing (i.e., single-task; 10 minutes). Treadmill walking in intervals of 2-4 minutes with rest periods. Walking over the ground while negotiating through obstacles. (10 minutes) The speed of the treadmill will be progressed gradually and as tolerated. | Other | Conventional Gait Rehabilitation |
Primary outcome
NDWP scores
Time frame: 10 weeks
NDWP scores on PET scans of participants will be analysed to identify gait impairment related imagining signatures during single and dual-task walking, and after intervention. They will also be compared to age-matched healthy controls using student t-test.
Step Length Coefficient of Variability
Time frame: 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Game based treadmill Program and Conventional Gait Rehabilitation 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 15 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 11 May 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tony Szturm, PhD ((204)-787-4794, tony.szturm@umanitoba.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NDWP scores (time frame: 10 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?
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 11 May 2021.