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Tele-rehabilitation in the Home With Gaming as a Method of Improving Upper Extremity Function After Stroke

Primary Purpose

Stroke, Hemiplegia

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Computer gaming hand exercise regimen.
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Hand exercises, Hand function, Computer based exercises, Therapeutic gaming

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • School of Medical Rehabilitation , University of MantiobaRecruiting
  • Riverview Health CentreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental Group

Arm Description

Computer gaming hand exercise regimen.

Outcomes

Primary Outcome Measures

Wolf Motor Function Test (Change is being assessed)

Secondary Outcome Measures

Stroke Impact Scale (Change is being assessed)
Change from baseline in Paddle game based hand function assessment tool from 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.

Full Information

First Posted
May 22, 2015
Last Updated
May 11, 2016
Sponsor
University of Manitoba
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1. Study Identification

Unique Protocol Identification Number
NCT02494362
Brief Title
Tele-rehabilitation in the Home With Gaming as a Method of Improving Upper Extremity Function After Stroke
Official Title
Tele-rehabilitation in the Home With Gaming as a Method of Improving Upper Extremity Function After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
May 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to determine whether a novel computer gaming hand exercise regimen would improve hand and arm function and be feasible in people with hemiplegia after Stroke affecting the hand.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiplegia
Keywords
Hand exercises, Hand function, Computer based exercises, Therapeutic gaming

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Computer gaming hand exercise regimen.
Intervention Type
Other
Intervention Name(s)
Computer gaming hand exercise regimen.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Wolf Motor Function Test (Change is being assessed)
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Stroke Impact Scale (Change is being assessed)
Time Frame
Baseline and 12 weeks
Title
Change from baseline in Paddle game based hand function assessment tool from baseline and 12 weeks.
Description
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.
Time Frame
Baseline and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tony Szturm, PhD
Phone
204-789-3897
Email
tony.szturm@umanitoba.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tony Szturm, PhD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Medical Rehabilitation , University of Mantioba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3e 0T6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tony Szturm, PT, PhD
Facility Name
Riverview Health Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3T 1a3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sepideh Pooyania, MD
Phone
(204) 478-6219
Email
spooyania@rhc.mb.ca

12. IPD Sharing Statement

Citations:
PubMed Identifier
18996252
Citation
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.
Results Reference
background
PubMed Identifier
21536526
Citation
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.
Results Reference
background
PubMed Identifier
18950989
Citation
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.
Results Reference
background

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Tele-rehabilitation in the Home With Gaming as a Method of Improving Upper Extremity Function After Stroke

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