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

Study 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.

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

Conditions
-----------------
Rheumatoid Arthritis, Osteoarthritis of Hands

Intervention / Treatment
-----------------
* Other: Conventional hand exercise program
* Other: Computer gaming hand exercise regimen


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>Conventional hand exercise program | Other: Conventional hand exercise program<br>* Exercises targeted to improve finger range of motion and hand strength.The exercises will be performed 30 minutes,four times per week for six weeks<br>|
| Experimental: Experimental group<br>Computer gaming hand exercise regimen' | Other: Computer gaming hand exercise regimen<br>* 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 six weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Arthritis Hand Function Test (AHFT) at 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. | Baseline and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Disabilities of Arm,Shoulder and Hand(DASH) questionnaire at 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 | Baseline and 6 weeks | 
| Change from baseline in Paddle game based hand function assessment tool at 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 | Baseline and 6 weeks | 
| Personal exercise log diary | Exercise compliance will be measured at the end of 6 weeks of home exercise program | End of 6 weeks of home exercise program | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hand exercises, Hand function, Computer based exercises, Therapeutic gaming