Novel Rehabilitation Strategies to Improve Arm Function in Patients With Scleroderma
NCT ID: NCT02837549
Last Updated: 2017-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
21 participants
INTERVENTIONAL
2016-07-31
2017-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Occupational therapy treatment
Participants will undergo the following as appropriate:
1. Thermal Modalities Hot packs, focused on areas with limitations Paraffin, focused on digital limitations
2. Application of the Physiotouch (a low-intensity negative pressure device)
3. Passive Range of Motion
4. Active Range of Motion
5. Functional Activities
Occupational therapy treatment
This intervention includes various thermal modalities, manual therapy, Physiotouch (Healthy Life Devices Ltd) and education
Interventions
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Occupational therapy treatment
This intervention includes various thermal modalities, manual therapy, Physiotouch (Healthy Life Devices Ltd) and education
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University of Alabama at Birmingham
OTHER
University of Michigan
OTHER
Responsible Party
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Susan Murphy
Associate Professor
Principal Investigators
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Susan Murphy, ScD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan - Department of Physical Medicine and Rehabilitation
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Countries
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References
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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.
Other Identifiers
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HUM00117117
Identifier Type: -
Identifier Source: org_study_id