- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02494362
Tele-rehabilitation in the Home With Gaming as a Method of Improving Upper Extremity Function After Stroke
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A novel computer gaming hand exercise regimen has been designed for people with hemiplegia after Stroke affecting the hand. The design allows a broad range of common objects of daily life to be seamlessly transformed into 'therapeutic' input devices by instrumenting with a small motion sense mouse. Based on individual abilities and treatment needs, objects are selected to train specific fine/ gross dexterous functions. The object manipulations (therapeutic exercises) are then used to control and play any commercially available computer game, making practice challenging and engaging.
The study is of twelve weeks duration comparing the computer gaming and conventional hand exercises in ten people with hemiplegia after Stroke affecting the hand. The investigators hypothesize that the game based exercises will improve hand function and will be feasible. A mixed-effect repeated measures analysis of variance will be conducted to test pre to post treatment outcomes.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Manitoba
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Winnipeg, Manitoba, Canada, R3e 0T6
- Recruiting
- School of Medical Rehabilitation , University of Mantioba
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Principal Investigator:
- Tony Szturm, PT, PhD
-
Winnipeg, Manitoba, Canada, R3T 1a3
- Recruiting
- Riverview Health Centre
-
Contact:
- Sepideh Pooyania, MD
- Phone Number: (204) 478-6219
- Email: spooyania@rhc.mb.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Time since stroke onset less than 1 year.
- Ability to actively extend at least 10 degrees at the Metacarpophalangeal and Interphalangeal joints and 10 degrees at the wrist. At least 30 degree of active flexion-extension at elbow and some active movements present at the shoulder joint.
- English speaking.
- No clinical evidence of cognitive impairment (screened by physician or therapist).
- Have a personal computer at home.
- Lives in Winnipeg.
- Able to provide informed consent.
Exclusion Criteria:
- Patients having excessive spasticity, pain or contractures in the more affected limb will not be included in the study.
- Convulsive seizures preventing adequate attention to task.
- Problem with vision.
- Aphasia.
- Apraxia.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group
Computer gaming hand exercise regimen.
|
Computer gaming hand exercise regimen using common objects of daily life.
The hand exercises are coupled with commercially available computer games and will be performed 30 minutes,four times per week for 12 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Wolf Motor Function Test (Change is being assessed)
Time Frame: Baseline and 12 weeks
|
Baseline and 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stroke Impact Scale (Change is being assessed)
Time Frame: Baseline and 12 weeks
|
Baseline and 12 weeks
|
|
|
Change from baseline in Paddle game based hand function assessment tool from baseline and 12 weeks.
Time Frame: Baseline and 12 weeks
|
A novel, paddle game based hand function assessment tool has been developed designed to: 1) Objectively quantify the quality of finger hand movements (task performance) during manipulation of broad range of common objects independent of physical properties, anatomical requirements and task goal/context, 2) Track changes in finger hand function over time and 3) Aid in clinical decision making.
|
Baseline and 12 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Szturm T, Peters JF, Otto C, Kapadia N, Desai A. Task-specific rehabilitation of finger-hand function using interactive computer gaming. Arch Phys Med Rehabil. 2008 Nov;89(11):2213-7. doi: 10.1016/j.apmr.2008.04.021.
- Lockery D, Peters JF, Ramanna S, Shay BL, Szturm T. Store-and-feedforward adaptive gaming system for hand-finger motion tracking in telerehabilitation. IEEE Trans Inf Technol Biomed. 2011 May;15(3):467-73. doi: 10.1109/TITB.2011.2125976.
- Andersen Hammond ER, Shay BL, Szturm T. Objective evaluation of fine motor manipulation-a new clinical tool. J Hand Ther. 2009 Jan-Mar;22(1):28-35; quiz 36. doi: 10.1197/j.jht.2008.06.006. Epub 2008 Aug 30.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H2015
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.
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