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Clinical Trials/NCT01635582
NCT01635582
Completed
Phase 2

Effects of Home Based Computer Gaming Hand Exercise Regimen in People With Rheumatoid Arthritis (RA) or Osteoarthritis (OA) -A Randomized Controlled Pilot Trial

University of Manitoba1 site in 1 country16 target enrollmentStarted: June 2012Last updated:

Overview

Phase
Phase 2
Status
Completed
Enrollment
16
Locations
1
Primary Endpoint
Change from baseline in Arthritis Hand Function Test (AHFT) at 6 weeks

Overview

Brief Summary

The purpose of the study is to determine whether a novel computer gaming hand exercise regimen would improve hand function, decrease pain/ stiffness and be feasible in people with Rheumatoid arthritis or Osteoarthritis affecting the hands.

Detailed Description

A novel computer gaming hand exercise regimen has been designed for people with Rheumatoid arthritis (RA) or Osteo arthritis (OA) affecting the hands. 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 six weeks duration comparing the computer gaming and conventional hand exercises in thirty people diagnosed with RA or OA affecting the hands. The investigators hypothesize that the game based exercises will improve hand function and reduce pain/stiffness and be feasible compared to the conventional hand exercises.A mixed-effect repeated measures analysis of variance will be conducted to test pre to post treatment outcomes. This will be the first study to evaluate the therapeutic effects and feasibility of the computer gaming hand exercise regimen in people with RA or OA.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
30 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Men and women
  • Aged between 30-70 years
  • Clinical diagnosis of Rheumatoid arthritis or Osteoarthritis of hands according to American college of rheumatology criteria
  • Must own a home computer and have basic working knowledge of computers.
  • Present with scores ranging from 0-75 on self-reported hand function ability with the Disabilities of Arm, Shoulder and Hand (DASH) questionnaire

Exclusion Criteria

  • Severely deformed finger joints
  • Neurological conditions of dominant side upper limb
  • Trauma in wrist or hand
  • Upper limb surgeries in previous six months
  • Co-existing hand conditions in the dominant hand
  • Problems with vision or hearing
  • Recent changes in drug regimen (Disease modifying anti-rheumatic drugs (DMARDs) or corticosteroids \<3 months)
  • Major diseases of heart or lungs or liver
  • DASH scores 0-75.

Outcomes

Primary Outcomes

Change from baseline in Arthritis Hand Function Test (AHFT) at 6 weeks

Time Frame: Baseline and 6 weeks

The Arthritis Hand Function Test(AHFT) is an 11-item performance based test to measure grip and pinch strength, dexterity, applied strength and applied dexterity in people with arthritis.

Secondary Outcomes

  • Personal exercise log diary(End of 6 weeks of home exercise program)
  • Change from baseline in Disabilities of Arm,Shoulder and Hand(DASH) questionnaire at 6 weeks(Baseline and 6 weeks)
  • Change from baseline in Paddle game based hand function assessment tool at 6 weeks(Baseline and 6 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr. Tony Szturm

Associate Professor

University of Manitoba

Study Sites (1)

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