Clinical trial NCT02494362: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Hemiplegia
Keywords: Hand exercises
Hand function
Computer based exercises
Therapeutic gaming
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2015-07-10
Enrollment: 15
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Wolf Motor Function Test (Change is being assessed)
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Stroke Impact Scale (Change is being assessed)
timeFrame: Baseline and 12 weeks
measure: Change from baseline in Paddle game based hand function assessment tool from baseline and 12 weeks.
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: School of Medical Rehabilitation , University of Mantioba
state: Manitoba
city: Winnipeg
country: Canada
facility: Riverview Health Centre
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Tony Szturm, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.