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Evaluation of a Computer Game Based Rehabilitation System for Assessment and Treatment of Balance and Gait Impairments in Individuals With Parkinson's Disease.

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ClinicalTrials.gov Identifier: NCT03232996
Recruitment Status : Not yet recruiting
First Posted : July 28, 2017
Last Update Posted : July 28, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Examining the feasibility and acceptability of the computer game based rehabilitation system for improving balance, gait and executive function in individuals with PD. This will involve a pilot case series intervention study of individuals with PD will be conducted.

Condition or disease Intervention/treatment
Parkinson Disease Parkinson Other: Computer game based balance and walking rehabilitation for individuals with Parkinson's Disease

Detailed Description:

This research study will involve a case series pilot study of individuals with PD. Conventional therapy programs for PD population target motor and cognitive deficits in isolation. Recently there has been a growing interest in the application of digital media in rehabilitation. Exergaming and the use of cognitive games have shown good results in patients with Traumatic brain injury, Cerebral palsy, stroke rehabilitation and geriatric population for mobility limitations and dementia.

All the 30 participants from the previous objective will be requested to take part in our objective 2. Objective 2 research protocol will be an 8- week (twice per week) training program of DT balance and DT walking exercises.

Each session will be 45 minutes long. A basic computer game based exercise program will be designed for each participant depending upon their functional status. Every Participant will receive orientation and training about CGBRS, motion mouse and video-games. For initial sessions, relatively slow and large target movements will be selected for the computer games. Game speed, amplitude, mouse sensitivity, and difficulty will be progressed as tolerated for each participant.

Participants will be asked to stand on a stationary treadmill, in front of a LED monitor which will be placed 1 meter away from the treadmill. The treadmill has front and side hand rails so is a convenient place to perform the DT balance activities. The participants will also be fitted with a safety harness. The participants will be asked to wear a head band which is instrumented with the motion sense mouse. Thus, hands-free head rotations will be used to interact with the computer games selected for the DT rehabilitation program. Six to eight computer games will be selected for each participant from a collection of over 60 purchased from Big Fish Games (www.bigfishgames.com). The computer games involve goal-directed visuospatial executive cognitive activities including visual search and tracking of multiple targets, movements of different speeds to interact with game targets with varying movement precision, the presence of distracters, matching and puzzle game.

Participants will play the computer games under the following conditions: -

  • While standing on a fixed surface (warm -up duration for 5 minutes)
  • While Standing on a compliant sponge pad to increase balance demands (duration - 10 minutes)
  • While walking on a treadmill at a predetermined comfortable speed for an interval of 2-3 minutes with 1-2 min rest periods (duration of the treadmill walking component will be 20 minutes.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of a Computer Game Based Rehabilitation System for Assessment and Treatment of Balance and Gait Impairments in Individuals With Parkinson's Disease.
Anticipated Study Start Date : September 1, 2017
Estimated Primary Completion Date : September 1, 2018
Estimated Study Completion Date : September 1, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Experimental Group
Computer Game based balance and walk rehabilitation
Other: Computer game based balance and walking rehabilitation for individuals with Parkinson's Disease
All the participants will take part in an 8 week (twice per week) computer game based exercise program for dual task balance and dual task walk training. Participants will be standing in front of LED monitor. They will be asked to wear a head band which will be instrumented with motion sense mouse. Thus, hands-free head rotations will be used to interact with the computer games selected for the DT rehabilitation program. Participants will play few interactive computer games during - Normal standing (fixed surface), Standing on a compliant sponge pad and then while walking on a treadmill.


Outcome Measures

Primary Outcome Measures :
  1. Dynamic Standing Balance [ Time Frame: Change from baseline Dynamic standing balance at 8 weeks ]
    The following tasks will be performed for 45 seconds while standing on a sponge pad; a) eyes open (EO), i.e. single task balance condition, and then b) performing the computer gaming activities (i.e. DT balance conditions). A force sensor array (FSA) pressure-sensing mat (Vista Medical Ltd., Manitoba, Canada) will be used to record vertical foot pressures and thus to compute center of foot pressure (COP) migration.

  2. Gait Assessment [ Time Frame: Change from baseline spatio-temporal gait variables at 8 weeks. ]
    The participant will first be asked to walk on the treadmill at his/her comfortable speed for 3 minutes to acclimate with the treadmill prior to testing. After a rest period of 2 minutes they will be asked to walk for 1 minute under the following conditions; a) walk only or single task condition and b) walking while performing the computer gaming tasks (DT walking condition). The treadmill instrumented with a pressure mat (Vista Medical, CA) will be used to record vertical foot contact forces and used to compute spatial-temporal gait variables. Participants walked for 5 minutes to acclimate to the treadmill prior to testing.


Secondary Outcome Measures :
  1. Unified Parkinson Disease Rating Scale (UPDRS) [ Time Frame: Change from baseline "Final UPDRS scores" at 8 weeks. ]
    UPDRS is the most common rating scale used to observe and quantify disability and impairment in Parkinson's Disease. This is a 5 point rating scale (from 0 to 5) which is assessed in an ordinal level. 0 describes absence or least severity while 4 describes the highest severity. Increase in severity is denoted with higher scores. Scores will be computed for behavior (part 1), Activites of Daily living (part 2) and Motor (part 3) sections. Scores of all the three section will be added and computed as the "Final UPDRS scores" for our clinical trial


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • Able to walk at least 50 meters without any assistance.

Exclusion Criteria:

  • Any psychiatric co-morbidity
  • Clinically diagnosed dementia or any clinically significant cognitive impairments.
  • History of neurological disorder other than PD, which could affect the performance of the participant
  • Orthopedic disorders which can affect gait or balance for the participant
  • Any unstable medical condition which majorly includes cardiovascular impairments.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03232996


Contacts
Contact: Mayank Bhatt, M. Sc. 14319982047 bhattm@myumanitoba.ca
Contact: Tony Szturm, Ph.D. tony.szturm@myumanitoba.ca

Locations
Canada, Manitoba
College of Rehabilitation Sciences, University of Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 0T6
Contact: Tony Szturm, Ph.d.    12047874704    tony.szturm@umanitoba.ca   
Sponsors and Collaborators
University of Manitoba
Investigators
Principal Investigator: Tony Szturm, Ph.D. Professor
More Information

Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT03232996     History of Changes
Other Study ID Numbers: H2017:225
First Posted: July 28, 2017    Key Record Dates
Last Update Posted: July 28, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Manitoba:
Balance
Gait

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases