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Planning for a Multisite Efficacy Trial of Upper Extremity Telerehabilitation for Systemic Sclerosis

Award Number: R34AR082551
ORGANIZATION: NATIONAL INSTITUTE OF ARTHRITIS & MUSCULOSKELETAL & SKIN DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 02/16/2024
PERIOD OF PERFORMANCE END DATE: 01/31/2026

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Planning for a Multisite Efficacy Trial of Upper Extremity Telerehabilitation for Systemic Sclerosis - Abstract Systemic sclerosis (SSc) is a rare, chronic autoimmune connective tissue disease affecting 60,000 – 100,000 people in the US. One main driver of physical disability in patients with SSc is upper extremity (UE) limitations due to vascular and skin changes. These disease changes reduce joint movement, cause pain, and when not treated early, can lead to permanent UE functional loss and rigidity, in the form of nonmalleable joint contractures. Along with conventional pharmacological treatments to counteract disease severity, rehabilitation is recommended to improve UE function and prevent long-lasting disability. Unfortunately, rehabilitation is only not highly utilized and there are several barriers to receiving rehabilitation services. Access and travel to SSc specialty centers are barriers, and traveling to repeated in-person sessions is not often logistically possible for patients. In addition, the evidence base for rehabilitation does not consist of replicable protocol-based treatments and relies on therapist expertise which results in variable care. The proposed study is designed to plan a multisite randomized clinical trial with specialty centers and community sites to assess the efficacy of a telerehab approach to improve UE function in patients with SSc. This is the result of several years of pilot testing and preliminary work establishing a standard protocol for therapy and testing telerehab methods of treatment. The planning for this multisite efficacy trial will result in adequate preparation and submission of a U01 application to conduct the trial. We hypothesize that a supervised and tailored UE telerehab program will lead to improved UE function in patients with diffuse cutaneous SSc compared to general education about symptom management. We propose the following aims: 1. Establish our multisite research team that includes occupational therapists who will serve as interventionists for the trial. 2. Complete the necessary milestones that will prepare us for a successful U01 project application: 1) Design and refine a multisite clinical trial protocol; 2) Develop a Manual of Operations and Procedures; 3) Refine telehealth platform and content; 4) Develop site-specific recruitment plans; 5) Develop a Data Safety and Monitoring Plan; 6) Establish our Data Management Plan; 7) Prepare and submit single-site IRB application; 8) Create training materials for the interventionists and therapist assessor; and 9) Conduct intervention fidelity training and test study processes. The proposed plan is the first step in examining the efficacy of UE telerehab intervention that has the potential to be scalable and translatable into clinical practice. Results of the trial would have implications for ongoing reimbursement for telerehab services and potentially provide broader access to treatment of this rare condition. In addition, these methods could be applied to other rheumatological conditions such as rheumatoid arthritis and lupus.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $99,871 )
2025	2025	REGENTS OF THE UNIVERSITY OF MICHIGAN	1109 GEDDES AVE STE 3300	ANN ARBOR	MI	48109	WASHTENAW	USA	Arthritis, Musculoskeletal and Skin Diseases Research	001	2	5/27/2025	NON-COMPETING CONTINUATION	$7,207
2025	2025	REGENTS OF THE UNIVERSITY OF MICHIGAN	1109 GEDDES AVE STE 3300	ANN ARBOR	MI	48109	WASHTENAW	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	2	3/17/2025	NON-COMPETING CONTINUATION	$92,664
														Subtotal = $99,871

Issue Date FY: 2024 ( Subtotal = $274,560 )
2024	2024	REGENTS OF THE UNIVERSITY OF MICHIGAN	1109 GEDDES AVE, SUITE 3300	ANN ARBOR	MI	48109	WASHTENAW	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	1	2/16/2024	NEW	$274,560
														Subtotal = $274,560

Grand Total All Awards = $374,431

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Planning for a Multisite Efficacy Trial of Upper Extremity Telerehabilitation for Systemic Sclerosis

Award Number: R34AR082551

ORGANIZATION: NATIONAL INSTITUTE OF ARTHRITIS & MUSCULOSKELETAL & SKIN DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 02/16/2024

PERIOD OF PERFORMANCE END DATE: 01/31/2026

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