Home Based Computer Gaming Hand Exercise Regimen for People With Arthritis Affecting the Hands

Phase 2

Completed

• Conditions: Osteoarthritis of Hands; Rheumatoid Arthritis
• Interventions: Other: Computer gaming hand exercise regimen; Other: Conventional hand exercise program

• Registration Number: NCT01635582
• Lead Sponsor: University of Manitoba

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 Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-29
• Study First Submitted QC: 2012-07-04
• Study First Posted: 2012-07-09
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-11
• Last Update Posted: 2014-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Computer gaming hand exercise regimen	Computer gaming hand exercise regimen'
Control group	Conventional hand exercise program	Conventional hand exercise program

Primary Outcome Measures

Name	Time	Method
Change from baseline in Arthritis Hand Function Test (AHFT) at 6 weeks	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 Outcome Measures

Name	Time	Method
Personal exercise log diary	End of 6 weeks of home exercise program	Exercise compliance will be measured at the end of 6 weeks of home exercise program
Change from baseline in Paddle game based hand function assessment tool at 6 weeks	Baseline and 6 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) Quantify pain and joint stiffness during each object manipulation task, 3) Track changes in finger hand function over time and 4) Aid in clinical decision making
Change from baseline in Disabilities of Arm,Shoulder and Hand(DASH) questionnaire at 6 weeks	Baseline and 6 weeks	The DASH is a self-report questionnaire, with 30 items designed to measure functional ability and symptoms in people with any of several musculo skeletal disorders of the upper limb

Trial Locations

Locations (1)

University of Manitoba; 🇨🇦 Winnipeg, Manitoba, Canada