NCT03232996

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 28, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

March 25, 2020

Status Verified

October 1, 2018

Enrollment Period

1.5 years

First QC Date

July 24, 2017

Last Update Submit

March 23, 2020

Conditions

Keywords

BalanceGait

Outcome Measures

Primary Outcomes (2)

  • Dynamic Standing Balance

    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

    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 Outcomes (1)

  • Unified Parkinson Disease Rating Scale (UPDRS)

    Change from baseline "Final UPDRS scores" at 8 weeks.

Study Arms (1)

Experimental Group

EXPERIMENTAL

Computer Game based balance and walk rehabilitation

Other: Computer game based balance and walking rehabilitation for individuals with Parkinson's Disease

Interventions

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.

Experimental Group

Eligibility Criteria

Age55 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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
  • Able to walk at least 50 meters without any assistance.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of Rehabilitation Sciences, University of Manitoba

Winnipeg, Manitoba, R3E 0T6, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Tony Szturm, Ph.D.

    Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single Group Assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2017

First Posted

July 28, 2017

Study Start

November 1, 2017

Primary Completion

April 30, 2019

Study Completion

August 1, 2019

Last Updated

March 25, 2020

Record last verified: 2018-10

Locations