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Publication . Other literature type . Article . Clinical Trial . 2017

Randomized feasibility trial of the Scleroderma Patient-centered Intervention Network hand exercise program (SPIN-HAND): Study protocol

Carrier, Marie-Eve; Kwakkenbos, Linda; Boutron, Isabelle; Welling, Joep; Sauve, Maureen; Ende, Cornelia van den; Schouffoer, Anne A.; +4 Authors
Open Access

doi: 10.5301/jsrd.5000263

handle: 2066/190460 , 1822/61572

pmc: PMC8892877

pmid: 35382119

Published: 16 Oct 2017
Abstract

Background: Significant functional impairment of the hands is nearly universal in systemic sclerosis (SSc, scleroderma). Hand exercises may improve hand function, but developing, testing and disseminating rehabilitation interventions in SSc is challenging. The Scleroderma Patient-centered Intervention Network (SPIN) was established to address this issue and has developed an online hand exercise program to improve hand function for SSc patients (SPIN-HAND). The aim of the proposed feasibility trial is to evaluate the feasibility of conducting a full-scale randomized controlled trial (RCT) of the SPIN-HAND intervention. Design and methods: The SPIN-HAND feasibility trial will be conducted via the SPIN Cohort. The SPIN Cohort was developed as a framework for embedded pragmatic trials using the cohort multiple RCT design. In total, 40 English-speaking SPIN Cohort participants with at least mild hand function limitations (Cochin Hand Function Scale ≥3) and an indicated interest in using an online hand-exercise intervention will be randomized with a 1:1 ratio to be offered to use the SPIN-HAND program or usual care for 3 months. The primary aim is to evaluate the trial implementation processes, required resources and management, scientific aspects, and participant acceptability and usage of the SPIN-HAND program. Discussion: The SPIN-HAND exercise program is a self-help tool that may improve hand function in patients with SSc. The SPIN-HAND feasibility trial will ensure that trial methodology is robust, feasible, and consistent with trial participant expectations. The results will guide adjustments that need to be implemented before undertaking a full-scale RCT of the SPIN-HAND program. Trial registration: ClinicalTrials.gov Identifier: NCT03092024.

Canadian Institutes of Health Research(undefined)

Subjects by Vocabulary

Microsoft Academic Graph classification: Physical medicine and rehabilitation medicine.medical_specialty medicine Scleroderma medicine.disease Functional impairment Patient centered business.industry business Exercise program Protocol (science) Hand function Intervention (counseling) Hand exercises Physical therapy

Subjects

Immunology, Rheumatology, Immunology and Allergy, Clinical Trial, Feasibility studies, Scleroderma, Systemic, Tele-rehabilitation, Trial protocols, Feasibility studies, Scleroderma, Systemic, Tele-rehabilitation, Trial protocols

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