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

Primary Purpose

Rheumatoid Arthritis, Osteoarthritis of Hands

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Conventional hand exercise program
Computer gaming hand exercise regimen
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Hand exercises, Hand function, Computer based exercises, Therapeutic gaming

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Manitoba

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

Experimental group

Arm Description

Conventional hand exercise program

Computer gaming hand exercise regimen'

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
Personal exercise log diary
Exercise compliance will be measured at the end of 6 weeks of home exercise program

Full Information

First Posted
June 29, 2012
Last Updated
October 11, 2014
Sponsor
University of Manitoba
Collaborators
Canadian Arthritis Network
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1. Study Identification

Unique Protocol Identification Number
NCT01635582
Brief Title
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

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba
Collaborators
Canadian Arthritis Network

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Osteoarthritis of Hands
Keywords
Hand exercises, Hand function, Computer based exercises, Therapeutic gaming

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Conventional hand exercise program
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Computer gaming hand exercise regimen'
Intervention Type
Other
Intervention Name(s)
Conventional hand exercise program
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Computer gaming hand exercise regimen
Intervention Description
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
Primary Outcome Measure Information:
Title
Change from baseline in Arthritis Hand Function Test (AHFT) at 6 weeks
Description
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.
Time Frame
Baseline and 6 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in Disabilities of Arm,Shoulder and Hand(DASH) questionnaire at 6 weeks
Description
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
Time Frame
Baseline and 6 weeks
Title
Change from baseline in Paddle game based hand function assessment tool at 6 weeks
Description
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
Time Frame
Baseline and 6 weeks
Title
Personal exercise log diary
Description
Exercise compliance will be measured at the end of 6 weeks of home exercise program
Time Frame
End of 6 weeks of home exercise program

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tony Szturm, PhD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0T6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
18996252
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.
Results Reference
background
PubMed Identifier
21536526
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.
Results Reference
background
PubMed Identifier
18950989
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.
Results Reference
background
PubMed Identifier
20609561
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.
Results Reference
background
PubMed Identifier
27623532
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.
Results Reference
derived
PubMed Identifier
23497529
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.
Results Reference
derived

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

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