Clinical trial NCT03232996: Evaluation of a Computer Game Based Rehabilitation System for Assessment and Treatment of Balance and Gait Impairments in Individuals With Parkinson's Disease.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Parkinson
Keywords: Balance
Gait
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2017-07-28
Enrollment: 30
Sex: ALL
Minimum age (years): 55
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment
Primary purpose: TREATMENT

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.

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.

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
* 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.

Primary outcomes:
measure: Dynamic Standing Balance
timeFrame: Change from baseline Dynamic standing balance at 8 weeks
measure: Gait Assessment
timeFrame: Change from baseline spatio-temporal gait variables at 8 weeks.
Secondary outcomes:
measure: Unified Parkinson Disease Rating Scale (UPDRS)
timeFrame: Change from baseline "Final UPDRS scores" at 8 weeks.
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: College of Rehabilitation Sciences, University of Manitoba
state: Manitoba
Study officials:
affiliation: Professor
name: Tony Szturm, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bhatt M, Mahana B, Ko JH, Kolesar TA, Kanitkar A, Szturm T. Computerized Dual-Task Testing of Gait Visuomotor and Cognitive Functions in Parkinson's Disease: Test-Retest Reliability and Validity. Front Hum Neurosci. 2021 Jul 15;15:706230. doi: 10.3389/fnhum.2021.706230. eCollection 2021.