Novel Rehabilitation Strategies to Improve Arm Function in Patients With Scleroderma
| Status: | Completed |
|---|---|
| Conditions: | Skin and Soft Tissue Infections, Dermatology, Dermatology, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/28/2017 |
| Start Date: | July 2016 |
| End Date: | September 2017 |
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.
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.
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.
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.
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
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