Rheumatoid Arthritis Clinical Trial
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
Verified date | October 2014 |
Source | University of Manitoba |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 16 |
Est. completion date | May 2014 |
Est. primary completion date | May 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 30 Years to 70 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | University of Manitoba | Winnipeg | Manitoba |
Lead Sponsor | Collaborator |
---|---|
University of Manitoba | Canadian Arthritis Network |
Canada,
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. — View Citation
Hammond E., Shay B., and Szturm T. (2010), Evaluation of Object Manipulation Skills: Comparison between Normal and a Simulated Index Finger Amputation. Journal of American Hand Therapy, Oct-Dec: 23(4):352-59; 360
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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
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