Changes in Metabolic Activity, and Gait Function by Dual-task Cognitive Game-based Treadmill Intervention in Parkinson's Disease.

NCT ID: NCT04415775

Last Updated: 2021-05-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2023-11-01

Brief 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). 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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Dual-task walking Intervention

Group Type: EXPERIMENTAL

Game based treadmill Program

Intervention Type: OTHER

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 Rehabilitation

Group Type: ACTIVE_COMPARATOR

Conventional Gait Rehabilitation

Intervention Type: OTHER

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.

Healthy Controls

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Game based treadmill Program

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.

Intervention Type: OTHER

Conventional Gait Rehabilitation

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

Exclusion Criteria

• 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.
• Any cardiovascular impairment limiting the ability to walk for 10-15 minutes on a treadmill.
• Abnormal MRI
• General contraindications.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Weston Brain Institute

OTHER

Sponsor Role: collaborator

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Dr. Tony Szturm

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

College of Rehabilitation Sciences, University of Manitoba

Winnipeg, Manitoba, Canada

Countries

Canada

Central Contacts

Tony Szturm, PhD

Role: CONTACT

tony.szturm@umanitoba.ca

(204)-787-4794

Other Identifiers

B2020:043

Identifier Type: -

Identifier Source: org_study_id