Novel Rehabilitation Strategies to Improve Arm Function in Patients With Scleroderma

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 Overview

• Status: Completed
• Conditions: Scleroderma; Ssc
• Intervention / Treatment: Other: Occupational therapy treatment

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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Other: Occupational therapy treatment; This intervention includes various thermal modalities, manual therapy, Physiotouch (Healthy Life Devices Ltd) and education; Other Names: Upper Extremity Rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
quickDASH	self-report questionnaire of physical function and symptoms	change over 8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: University of Alabama at Birmingham
• Investigators: Principal Investigator: Susan Murphy, ScD, University of Michigan - Department of Physical Medicine and Rehabilitation

Publications and helpful links

General Publications

• Murphy SL, Barber MW, Homer K, Dodge C, Cutter GR, Khanna D. Occupational Therapy Treatment to Improve Upper Extremity Function in Individuals with Early Systemic Sclerosis: A Pilot Study. Arthritis Care Res (Hoboken). 2018 Nov;70(11):1653-1660. doi: 10.1002/acr.23522.

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: July 5, 2016
• First Submitted That Met QC Criteria: July 15, 2016
• First Posted (Estimate): July 19, 2016

Study Record Updates

• Last Update Posted (Actual): October 26, 2017
• Last Update Submitted That Met QC Criteria: October 24, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Connective Tissue Diseases; Scleroderma, Systemic; Scleroderma, Diffuse; Scleroderma, Localized
• Other Study ID Numbers: HUM00117117

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: upon written request