Clinical trial NCT01635582: Home Based Computer Gaming Hand Exercise Regimen for People With Arthritis Affecting the Hands
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Osteoarthritis of Hands
Keywords: Hand exercises
Hand function
Computer based exercises
Therapeutic gaming
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Canadian Arthritis Network
First posted: 2012-07-09
Enrollment: 16
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from baseline in Arthritis Hand Function Test (AHFT) at 6 weeks
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: Change from baseline in Disabilities of Arm,Shoulder and Hand(DASH) questionnaire at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change from baseline in Paddle game based hand function assessment tool at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Personal exercise log diary
timeFrame: End of 6 weeks of home exercise program
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Tony Szturm, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: 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.
citation: Hammond ER, Szturm T, Shay BL. Manipulation of objects with and without the use of the index finger: implications for digital amputations. J Hand Ther. 2010 Oct-Dec;23(4):352-59; quiz 360. doi: 10.1016/j.jht.2010.04.005. Epub 2010 Jul 6.
citation: Srikesavan CS, Shay B, Szturm T. Task-Oriented Training with Computer Games for People with Rheumatoid Arthritis or Hand Osteoarthritis: A Feasibility Randomized Controlled Trial. Games Health J. 2016 Oct;5(5):295-303. doi: 10.1089/g4h.2016.0005. Epub 2016 Sep 13.
citation: Srikesavan CS, Shay B, Robinson DB, Szturm T. Task-oriented training with computer gaming in people with rheumatoid arthritisor osteoarthritis of the hand: study protocol of a randomized controlled pilot trial. Trials. 2013 Mar 9;14:69. doi: 10.1186/1745-6215-14-69.