• shareshare
  • link
  • cite
  • add
auto_awesome_motion View all 7 versions
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

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: 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


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

41 references, page 1 of 5

Seibold J. Scleroderma. In: Harris ED, Budd RC, Firestein GS, et al, eds. Kelley's textbook of rheumatology. 7th ed. Philadelphia, PA: Elsevier 2005; 1279-1308.

In: Hochberg MC, Silman AJ, Smolen JS, et al., eds. Rheumatology. Philadelphia: Mosby 2003;1463-1480.

Bassel M, Hudson M, Taillefer SS, Schieir O, Baron M, Thombs BD. Frequency and impact of symptoms experienced by paitents with systemic sclerosis: results from a Canadian National Survey. Rheumatology (Oxford). 2011;50(4):762-767.

Thombs BD, van Lankveld W, Bassel M, et al. Psychological health and well-being in systemic sclerosis: State of the science and consensus research agenda. Arthritis Care Res (Hoboken). 2010;62(8):1181-1189.

5. Kwakkenbos L, Delisle VC, Fox RS, et al. Psychosocial aspects of scleroderma. Rheum Dis Clin North Am. 2015;41(3):519-528.

6. Jewet LR, Haythornthwaite JA, Thombs BD. Psychosocial issues and care for paetints with systemic sclerosis. In: Varga J, Denton CP, Wigley FM, eds. Scleroderma: from pathogenesis to comprehensive management. New York: Springer 2012;641-648.

7. Kowal-Bielecka O, Landewé R, Avouac J, et al. EUSTAR CoAuthors. EULAR recommendaotins for the treatment of systemic sclerosis: a report from the EULAR Scleroderma Trials and Research group (EUSTAR). Ann Rheum Dis. 2009;68(5):620-628.

8. Kwakkenbos L, Jewet LR, Baron M, et al. The Scleroderma Paeitnt-centered Intervenotin Network (SPIN) Cohort: protocol for a cohort mulptile randomised controlled trial (cmRCT) design to support trials of psychosocial and rehabilitaotin intervenoitns in a rare disease context. BMJ Open. 2013;3(8):e003563.

9. Kole A, Faurisson F. The voice of 12,000 patients: experiences and expectations of rare disease patients on diagnosis and care in Europe. Available from: pdf/voice_12000_patients/EURORDISCARE_FULLBOOKr.pdf. Accessed September 19, 2017.

10. Huyard C. What, if anything, is specific about having a rare dis - order? Patients judgements on being ill and being rare. Health Expect. 2009;12(4):361-370. [OpenAIRE]

Funded by
  • Funder: Canadian Institutes of Health Research (CIHR)
Download fromView all 6 sources
Europe PubMed Central
Other literature type . 2017
Providers: PubMed Central