Novel Tools for the Delivery and Assessment of Exercise Programs Adapted to Individuals With Parkinson's Disease

NCT04078217 | Unknown

• 1 other identifier: CER VN 18-19-38
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The study will aim to determine whether a technology-based personalized home exercise program delivered asynchronously and supervised remotely by a kinesiologist is more effective in improving gait than a similar home-based exercise program without technology nor remote supervision. The main hypothesis is that the proposed intervention with the technology will provide significant improvements in gait performance and higher adherence/satisfaction over the non-supervised exercise program. Both groups will be composed of people with Parkinson's disease. They will have the same evaluation pre and post intervention, the same number of visits from the kinesiologist to deliver the exercise program at home. The difference is the information gathered from the technology; for example, the completion level of each training, success or failure of selected exercises, connection to exercise session, etc. In addition, kinesiologist can remotely adjust difficulty of exercise and take action quickly if the participant hasn't logged in the training system. Total duration for a participant is 16 weeks: pre-evaluation at home and at lab, 12 weeks home-based exercise program, post-evaluation at home and lab (same as before exercise program). Pre- and post-evaluation: 7 days wearing an Apple watch to measure mobility in participant environment (participant is met at home and continues normal activities), than comes to lab to undergo physical and balance tests, and scans to analyse body composition (fat, muscle and bone structures). Participant needs to be in "off" state when arriving at the lab; not have taken the morning PD medication. Will take it at the lab with breakfast, after the first tests.

Conditions

Parkinson Disease

Keywords

home-based exercise program; gait; mobility

Outcome Measures

Primary Outcomes (3)

• Gait parameters

  Distance walked in 6 min (in meters)

  6 min walk test

• Technology feasibility

  Automated logs from Jintronix system (performance on each exercise-game)

  12 weeks

• Technology acceptability

  Automated logs from Jintronix system (compliance)

  12 weeks

Secondary Outcomes (3)

• Ecological activity

  Minimum 7 days

• Ecological mobility

  Minimum 7 days

• Functional capacity

  10 minutes

Study Arms (2)

Jintronix

EXPERIMENTAL

Jintronix Rehabilitation System uses Microsoft Kinect cameras to track patient's movements in 3D during exercises. They are programmed as games that are visualized on a TV and for which performance feedback is provided to the participant. Individualized asynchronous supervised home-base exercise program using the Jintronix System, 3 times/week for 12 weeks (36 sessions). A trained kinesiologist will install the system and supervise the exercise program, in person and remotely.

Device: Jintronix

Control

ACTIVE COMPARATOR

Participants in this group will follow an individualized non-supervised home-based exercise program (booklet format). The exercise program will include 3 sessions per week for 12 consecutive weeks, as for Jintronix group. Actually, all movements of the booklet program are selected to match the exercise-games of the technology (similar movement, muscles engagement, etc.). A trained kinesiologist will explain and supervise the exercise program for the first sessions. The communication frequence will be the same as the Jintronix group.

Other: Booklet

Interventions

Jintronix DEVICE

Participants will perform an exercise program at home through a telerehabilitation platform called Jintronix.

Jintronix

Booklet OTHER

Home-based exercise program using a paper booklet (not the technology).

Control

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of PD from a neurologist based on the clinical diagnostic criteria for PD based on the recent work of Postuma and colleagues
• Hoehn and Yahr stages 1 to 3
• lives on the island of Montreal

You may not qualify if:

• Unstable medical/psychiatric comorbidities
• History of other movement disorders
• Orthopedic conditions restricting exercise
• Already performing more than 20 minutes of aerobic exercise more than 3 times per week (to avoid prior training effect)

Sponsors & Collaborators

• Université du Québec a Montréal: lead
• Weston Brain Institute: collaborator

Study Sites (1)

Centre de recherche de l'Institut universitaire de gériatrie de Montréal

Montreal, Quebec, H3W 1W5, 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

Study Officials

• Christian Duval, PhD

  Université du Québec a Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: One of the investigator (the research assistant) will not know the type of intervention (technology or booklet), until the last week of testing when the investigator takes back the equipment for intervention.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 15, 2019
• First Posted: September 4, 2019
• Study Start: September 3, 2019
• Primary Completion: December 1, 2020
• Study Completion: June 1, 2021
• Last Updated: November 3, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)