Clinical Trial: Novel Rehabilitation Strategies to Improve Arm Function in Patients With Scleroderma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Novel Rehabilitation Strategies to Improve Arm Function in Patients With Scleroderma

Brief Summary: The purpose of this study is to determine the feasibility and preliminary effects of a novel treatment approach to improve arm function in patients with scleroderma who have upper extremity contractures. It is a Phase 1, one arm trial in which participants will be assessed at baseline, 4 weeks, and 8 weeks. The rehabilitation intervention will involve 8 individual sessions with an occupational therapist. Feasibility of the procedures is a major focus of this project.

Detailed Summary:

Our specific aims are to:

  1. Determine the feasibility of a novel rehabilitation strategy provided at the University of Michigan Scleroderma Clinic to scleroderma patients who have upper extremity contractures.

    Investigators will assess 3 main aspects of the process that are key to the success of a larger study including the proportion of eligible people who enroll in the study, rate of adherence to the treatment protocol, and the time it takes to conduct sessions including treatment and outcome assessment completion. Based on a framework of recommendations for well-designed pilot studies [1], investigators have set the following criteria for success to examine these aspects:

    1. At least 50% of participants who are eligible for the study will enroll.
    2. At least 80% of participants will attend all treatment sessions.
    3. The 3 sessions involving both treatment and outcome assessments will not last on average more than 2 hours.

  2. Develop a standardized treatment manual to train therapists to provide this treatment to their patients.

    A standardized treatment manual for therapists is a critical component needed to ensure consistency in a larger multi-site trial. This manual will be drafted for use in this study and refined as needed.

  3. Establish preliminary effects of this 8-week rehabilitation program on improving arm function.

Investigators hypothesize that participants with sc
Sponsor: University of Michigan

Current Primary Outcome: quickDASH [ Time Frame: at least 8 weeks ]

self-report questionnaire of physical function and symptoms


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Upper extremity range of motion [ Time Frame: at least 8 weeks ]
    Active and Passive Range of Motion measured by goniometer
  • Skin integrity [ Time Frame: at least 8 weeks ]
    Rodnan skin score
  • Dexterity [ Time Frame: at least 8 weeks ]
    9 hole peg test
  • Dexterity [ Time Frame: at least 8 weeks ]
    pinch strength tests
  • Dexterity [ Time Frame: at least 8 weeks ]
    grip strength tests
  • Physical Function [ Time Frame: at least 8 weeks ]
    PROMIS physical function 8-item short form
  • Hand Mobility [ Time Frame: at least 8 weeks ]
    9 hole peg test
  • Hand Mobility [ Time Frame: at least 8 weeks ]
    grip strength tests
  • Hand Mobility [ Time Frame: at least 8 weeks ]
    pinch strength tests


Original Secondary Outcome: Same as current

Information By: University of Michigan

Dates:
Date Received: July 5, 2016
Date Started: July 2016
Date Completion: August 2018
Last Updated: November 1, 2016
Last Verified: November 2016