NCT02494362

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 10, 2015

Completed
22 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

May 13, 2016

Status Verified

May 1, 2016

Enrollment Period

1.8 years

First QC Date

May 22, 2015

Last Update Submit

May 11, 2016

Conditions

StrokeHemiplegia

Keywords

Hand exercisesHand functionComputer based exercisesTherapeutic gaming

Outcome Measures

Primary Outcomes (1)

  • Wolf Motor Function Test (Change is being assessed)

    Baseline and 12 weeks

Secondary Outcomes (2)

  • Stroke Impact Scale (Change is being assessed)

    Baseline and 12 weeks

  • Change from baseline in Paddle game based hand function assessment tool from baseline and 12 weeks.

    Baseline and 12 weeks

Study Arms (1)

Experimental Group

EXPERIMENTAL

Computer gaming hand exercise regimen.

Other: Computer gaming hand exercise regimen.

Interventions

Computer gaming hand exercise regimen.OTHER

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.

Experimental Group

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

School of Medical Rehabilitation , University of Mantioba

Winnipeg, Manitoba, R3e 0T6, Canada

RECRUITING

Riverview Health Centre

Winnipeg, Manitoba, R3T 1a3, Canada

RECRUITING

Related Publications (3)

  • 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.

    PMID: 18996252BACKGROUND

  • 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.

    PMID: 21536526BACKGROUND

  • 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.

    PMID: 18950989BACKGROUND

MeSH Terms

Conditions

StrokeHemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Tony Szturm, PhD

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tony Szturm, PhD

CONTACT

204-789-3897tony.szturm@umanitoba.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 22, 2015

First Posted

July 10, 2015

Study Start

August 1, 2015

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

May 13, 2016

Record last verified: 2016-05

Locations

CA(2)