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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02494362
• Other study ID #: H2015
• Status: Recruiting
• Phase: N/A
• First received: May 22, 2015
• Last updated: May 11, 2016
• Start date: August 2015
• Est. completion date: May 2017

Study information

• Verified date: May 2016
• Source: University of Manitoba
• Contact: Tony Szturm, PhD
• Phone: 204-789-3897
• Email: tony.szturm[@]umanitoba.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemiplegia
• Stroke

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Canada	Riverview Health Centre	Winnipeg	Manitoba
Canada	School of Medical Rehabilitation , University of Mantioba	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wolf Motor Function Test (Change is being assessed)		Baseline and 12 weeks	No
Secondary	Stroke Impact Scale (Change is being assessed)		Baseline and 12 weeks	No
Secondary	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.	Baseline and 12 weeks	No