Novel Rehabilitation Strategies to Improve Arm Function in Patients With Scleroderma

Scleroderma Clinical Trial

Official title:

Novel Rehabilitation Strategies to Improve Arm Function in Patients With Scleroderma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02837549
• Other study ID #: HUM00117117
• Status: Completed
• Phase: N/A
• First received: July 5, 2016
• Last updated: October 24, 2017
• Start date: July 2016
• Est. completion date: September 2017

Study information

• Verified date: October 2017
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Scleroderma
• Scleroderma, Diffuse
• Scleroderma, Localized
• Scleroderma, Systemic
• Ssc

Intervention

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

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quickDASH	self-report questionnaire of physical function and symptoms	change over 8 weeks
Secondary	Upper extremity range of motion	Active and Passive Range of Motion measured by goniometer	change over 8 weeks
Secondary	Coordination	9 hole peg test	change over 8 weeks
Secondary	Grip Strength	dynanometer	change over 8 weeks
Secondary	Physical Function	PROMIS physical function 8-item short form	change over 8 weeks