Abstract
BackgroundSignificant restriction in the ability to participate in home, work and community life results from pain, fatigue, joint damage, stiffness and reduced joint range of motion and muscle strength in people with rheumatoid arthritis or osteoarthritis of the hand. With modest evidence on the therapeutic effectiveness of conventional hand exercises, a task-oriented training program via real life object manipulations has been developed for people with arthritis. An innovative, computer-based gaming platform that allows a broad range of common objects to be seamlessly transformed into therapeutic input devices through instrumentation with a motion-sense mouse has also been designed. Personalized objects are selected to target specific training goals such as graded finger mobility, strength, endurance or fine/gross dexterous functions. The movements and object manipulation tasks that replicate common situations in everyday living will then be used to control and play any computer game, making practice challenging and engaging.Methods/DesignThe ongoing study is a 6-week, single-center, parallel-group, equally allocated and assessor-blinded pilot randomized controlled trial. Thirty people with rheumatoid arthritis or osteoarthritis affecting the hand will be randomized to receive either conventional hand exercises or the task-oriented training. The purpose is to determine a preliminary estimation of therapeutic effectiveness and feasibility of the task-oriented training program. Performance based and self-reported hand function, and exercise compliance are the study outcomes. Changes in outcomes (pre to post intervention) within each group will be assessed by paired Student t test or Wilcoxon signed-rank test and between groups (control versus experimental) post intervention using unpaired Student t test or Mann–Whitney U test.DiscussionThe study findings will inform decisions on the feasibility, safety and completion rate and will also provide preliminary data on the treatment effects of the task-oriented training compared with conventional hand exercises in people with rheumatoid arthritis or osteoarthritis of the hand.Trial registrationClinicalTrials.gov: NCT01635582
Highlights
Significant restriction in the ability to participate in home, work and community life results from pain, fatigue, joint damage, stiffness and reduced joint range of motion and muscle strength in people with rheumatoid arthritis or osteoarthritis of the hand
The study findings will inform decisions on the feasibility, safety and completion rate and will provide preliminary data on the treatment effects of the task-oriented training compared with conventional hand exercises in people with rheumatoid arthritis or osteoarthritis of the hand
Based on the data distribution of the study outcomes, grip strength, peg-board dexterity, applied dexterity and applied strength (Arthritis Hand Function Test items), DASH and number of exercise sessions completed in 6 weeks, changes over time within each group will be assessed by paired Student t test or Wilcoxon signed-rank test
Summary
To minimize the presence of any comorbid conditions associated with aging, the age range of the study participants included in the present study is between 30 and 60 years This may be a younger age group than many clinic populations, if there is failure to find an effect in this age group it is less likely that an effect will be found in an older group. As this study was designed to test the feasibility and obtain preliminary data on the effectiveness of the task-oriented training, no formal measures of disease activity were incorporated to interpret the effects of the interventions. This may limit the generalizability of the results to individuals with RA or OA that are relatively healthy, this is appropriate in a pilot study. Authors’ contributions CSS, BS, DBR and TS have substantially contributed to the conception and design, data collection and analysis procedures; have been involved in drafting the manuscript and revising it critically for important intellectual content; and have given final approval of the version to be published
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