Novel Rehabilitation Strategies to Improve Arm Function in Patients With Scleroderma

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2017

Detailed Description

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 scleroderma will have significant improvements in the QuickDASH disability measure at post test. Although the investigators think large effects will be shown, this study will allow us to determine estimates of the effects and the variability for power calculations in a multi-site trial.

Interventions

  • Other: Occupational therapy treatment
    • This intervention includes various thermal modalities, manual therapy, Physiotouch (Healthy Life Devices Ltd) and education

Arms, Groups and Cohorts

  • Experimental: Occupational therapy treatment
    • Participants will undergo the following as appropriate: Thermal Modalities Hot packs, focused on areas with limitations Paraffin, focused on digital limitations Application of the Physiotouch (a low-intensity negative pressure device) Passive Range of Motion Active Range of Motion Functional Activities

Clinical Trial Outcome Measures

Primary Measures

  • quickDASH
    • Time Frame: change over 8 weeks
    • self-report questionnaire of physical function and symptoms

Secondary Measures

  • Upper extremity range of motion
    • Time Frame: change over 8 weeks
    • Active and Passive Range of Motion measured by goniometer
  • Coordination
    • Time Frame: change over 8 weeks
    • 9 hole peg test
  • Grip Strength
    • Time Frame: change over 8 weeks
    • dynanometer
  • Physical Function
    • Time Frame: change over 8 weeks
    • PROMIS physical function 8-item short form

Participating in This Clinical Trial

Inclusion Criteria

  • diagnosis of scleroderma (localized or generalized morphea) – Have a contracture of the hand and other joint in at least one arm, such as wrist, elbow, or shoulder, with the ability to demonstrate active range of motion in that arm – Willing to travel to participate in therapy and outcome assessments. – English speaking Exclusion Criteria:

  • active hand ulcers

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Michigan
  • Collaborator
    • University of Alabama at Birmingham
  • Provider of Information About this Clinical Study
    • Principal Investigator: Susan Murphy, Associate Professor – University of Michigan
  • Overall Official(s)
    • Susan Murphy, ScD, Principal Investigator, University of Michigan – Department of Physical Medicine and Rehabilitation

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