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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01635582
• Other study ID #: H2012:182
• Status: Completed
• Phase: Phase 2
• First received: June 29, 2012
• Last updated: October 11, 2014
• Start date: June 2012
• Est. completion date: May 2014

Study information

• Verified date: October 2014
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Osteoarthritis
• Osteoarthritis of Hands
• Rheumatoid Arthritis

Intervention

Other:
• Conventional hand exercise program
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
• Computer gaming hand exercise regimen
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

Locations

Country	Name	City	State
Canada	University of Manitoba	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	Canadian Arthritis Network

Country where clinical trial is conducted

Canada, 

References & Publications (4)

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

Outcome

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