Novel Rehabilitation Strategies to Improve Arm Function in Patients With Scleroderma
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|ClinicalTrials.gov Identifier: NCT02837549|
Recruitment Status : Completed
First Posted : July 19, 2016
Last Update Posted : October 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Scleroderma Ssc||Other: Occupational therapy treatment||Not Applicable|
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 , investigators have set the following criteria for success to examine these aspects:
- At least 50% of participants who are eligible for the study will enroll.
- At least 80% of participants will attend all treatment sessions.
- The 3 sessions involving both treatment and outcome assessments will not last on average more than 2 hours.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Novel Rehabilitation Strategies to Improve Arm Function in Patients With Scleroderma|
|Study Start Date :||July 2016|
|Actual Primary Completion Date :||September 2017|
|Actual Study Completion Date :||September 2017|
Experimental: Occupational therapy treatment
Participants will undergo the following as appropriate:
Other: Occupational therapy treatment
This intervention includes various thermal modalities, manual therapy, Physiotouch (Healthy Life Devices Ltd) and education
Other Name: Upper Extremity Rehabilitation
- quickDASH [ Time Frame: change over 8 weeks ]self-report questionnaire of physical function and symptoms
- Upper extremity range of motion [ Time Frame: change over 8 weeks ]Active and Passive Range of Motion measured by goniometer
- Coordination [ Time Frame: change over 8 weeks ]9 hole peg test
- Grip Strength [ Time Frame: change over 8 weeks ]dynanometer
- Physical Function [ Time Frame: change over 8 weeks ]PROMIS physical function 8-item short form
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837549
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Susan Murphy, ScD||University of Michigan - Department of Physical Medicine and Rehabilitation|