Novel Rehabilitation Strategies to Improve Arm Function in Patients With Scleroderma

Not Applicable

Completed

• Conditions: Scleroderma; Ssc

• Registration Number: NCT02837549
• Lead Sponsor: University of Michigan

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 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 Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-07-05
• Study First Submitted QC: 2016-07-15
• Study First Posted: 2016-07-19
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-24
• Last Update Posted: 2017-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
quickDASH	change over 8 weeks	self-report questionnaire of physical function and symptoms

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States