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

NCT04415775 | Unknown

• 1 other identifier: B2020:043
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Dual task walking; Treadmill walking; PET scans; Parkinson Disease

Outcome Measures

Primary Outcomes (2)

• 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.

  10 weeks

• Step Length Coefficient of Variability

  10 weeks

Study Arms (3)

Dual-task walking Intervention

EXPERIMENTAL

Other: Game based treadmill Program

Conventional Gait Rehabilitation

ACTIVE COMPARATOR

Other: Conventional Gait Rehabilitation

Healthy Controls

NO INTERVENTION

Interventions

Game based treadmill Program 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.

Dual-task walking Intervention

Conventional Gait Rehabilitation 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.

Conventional Gait Rehabilitation

Eligibility Criteria

• Age: 55 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.
• Any orthopedic impairment affecting gait and balance.

Sponsors & Collaborators

• University of Manitoba: lead
• Weston Brain Institute: collaborator

Study Sites (1)

College of Rehabilitation Sciences, University of Manitoba

Winnipeg, Manitoba, R3E 0T6, Canada

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Tony Szturm, PhD

CONTACT

(204)-787-4794; tony.szturm@umanitoba.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: One experimental group and other control group receiving control intervention.

Study Record Dates

• First Submitted: May 28, 2020
• First Posted: June 4, 2020
• Study Start: June 1, 2021
• Primary Completion: August 1, 2023
• Study Completion: November 1, 2023
• Last Updated: May 11, 2021

Record last verified: 2021-05

Locations

CA (1)