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

March 23, 2020 updated by: University of Manitoba
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0T6
        • College of Rehabilitation Sciences, University of Manitoba

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline Dynamic standing balance at 8 weeks
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.
Change from baseline spatio-temporal gait variables at 8 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from baseline "Final UPDRS scores" at 8 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manitoba

Investigators

  • Principal Investigator: Tony Szturm, Ph.D., Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2017

Primary Completion (ACTUAL)

April 30, 2019

Study Completion (ACTUAL)

August 1, 2019

Study Registration Dates

First Submitted

July 24, 2017

First Submitted That Met QC Criteria

July 25, 2017

First Posted (ACTUAL)

July 28, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 25, 2020

Last Update Submitted That Met QC Criteria

March 23, 2020

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H2017:225

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parkinson Disease

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Finland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe