NCT01635582

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_2 rheumatoid-arthritis

Timeline
Completed

Started Jun 2012

Typical duration for phase_2 rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

June 29, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 9, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

October 15, 2014

Status Verified

October 1, 2014

Enrollment Period

1.9 years

First QC Date

June 29, 2012

Last Update Submit

October 11, 2014

Conditions

Keywords

Hand exercisesHand functionComputer based exercisesTherapeutic gaming

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Change from baseline in Disabilities of Arm,Shoulder and Hand(DASH) questionnaire at 6 weeks

    Baseline and 6 weeks

  • Change from baseline in Paddle game based hand function assessment tool at 6 weeks

    Baseline and 6 weeks

  • Personal exercise log diary

    End of 6 weeks of home exercise program

Study Arms (2)

Control group

ACTIVE COMPARATOR

Conventional hand exercise program

Other: Conventional hand exercise program

Experimental group

EXPERIMENTAL

Computer gaming hand exercise regimen'

Other: Computer gaming hand exercise regimen

Interventions

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

Control group

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

Experimental group

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, R3E 0T6, Canada

Location

Related Publications (6)

  • 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.

    PMID: 18996252BACKGROUND
  • 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.

    PMID: 21536526BACKGROUND
  • 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.

    PMID: 18950989BACKGROUND
  • 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.

    PMID: 20609561BACKGROUND
  • 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.

  • 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.

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Tony Szturm, PhD

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 29, 2012

First Posted

July 9, 2012

Study Start

June 1, 2012

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

October 15, 2014

Record last verified: 2014-10

Locations