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| Name | Class |
|---|---|
| University of Alabama at Birmingham | OTHER |
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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.
Our specific aims are to:
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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Occupational therapy treatment | Experimental | Participants will undergo the following as appropriate:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Occupational therapy treatment | Other | This intervention includes various thermal modalities, manual therapy, Physiotouch (Healthy Life Devices Ltd) and education |
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| Measure | Description | Time Frame |
|---|---|---|
| quickDASH | self-report questionnaire of physical function and symptoms | change over 8 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan Murphy, ScD | University of Michigan - Department of Physical Medicine and Rehabilitation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29381834 | Derived | 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. |
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upon written request
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| ID | Term |
|---|---|
| D045743 | Scleroderma, Diffuse |
| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D009788 | Occupational Therapy |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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|
| change over 8 weeks |
| Grip Strength | dynanometer | change over 8 weeks |
| Physical Function | PROMIS physical function 8-item short form | change over 8 weeks |
| D013812 |
| Therapeutics |