NCT04179292

Brief Summary

The aim of this study was to investigate the effectiveness of physiotherapy and rehabilitation program on hand involvement of patients with scleroderma and to compare the effects of home rehabilitation program and rehabilitation program under physiotherapist supervision. At the end of the study, the rehabilitation program under the supervision of physiotherapist and home exercise program will be compared with the effects of these applications on range of motion, grip strength, function and sensation. Since there are a limited number of randomized controlled studies in the literature on this subject and there is no randomized controlled clinical study on the superiority of physiotherapist supervision and home program, it will contribute to the information regarding the rehabilitation of scleroderma patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2019

Completed
15 days until next milestone

Study Start

First participant enrolled

November 21, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 27, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2021

Completed
Last Updated

January 28, 2021

Status Verified

January 1, 2021

Enrollment Period

1 year

First QC Date

November 6, 2019

Last Update Submit

January 26, 2021

Conditions

SclerodermaSystemic SclerosisHand RheumatismPhysiotherapyRehabilitation

Keywords

SclerodermaSystemic sclerosisHand therapy

Outcome Measures

Primary Outcomes (1)

  • Hand Mobility in Scleroderma (HAMIS)

    Hand Mobility in Scleroderma is a hand function test developed for adults who have systemic sclerosis. HAMIS consists of 9 items designed to measure all movements assessed in an ordinary range of motion-measured hand test. Each item is graded on a 0-3 scale, where 0 corresponds to normal function and 3 denotes that the individual is unable to perform the item. Each hand is assessed separately. The total score of HAMIS for each hand is 370 Sandqvist and Eklund Vol. 13, No. 6, December 2000 27, which represents a high degree of dysfunction.

    before treatment, at 8 weeks, 16 weeks, and 12 months change

Secondary Outcomes (6)

  • 9-Hole Peg Test

    before treatment, at 8 weeks, 16 weeks, and 12 months change

  • Duruöz Hand Index

    before treatment, at 8 weeks, 16 weeks, and 12 months change

  • Scleroderma Health Assessment Questionnaire (SHAQ)

    before treatment, at 8 weeks, 16 weeks, and 12 months change

  • Semmes Weinstein Monofilaman Test

    before treatment, at 8 weeks, 16 weeks, and 12 months change

  • Pittsburgh Sleep Quality Index (PSQI)

    before treatment, at 8 weeks, 16 weeks, and 12 months change

  • +1 more secondary outcomes

Study Arms (2)

Physiotherapy Program

EXPERIMENTAL

Stretching and strengthening exercises, functional exercises, massage techniques, sensory training and breathing exercises will be applied to the patients by physiotherapist for 3 sessions per week. On the other days, it will be implemented as an 8-week home program with 5 sessions per week.

Other: Hand Therapy by Physiotherapist

Home Program

EXPERIMENTAL

Stretching and strengthening exercises, functional exercises, massage techniques, sensory training and breathing exercises will be applied to the patients as home program. Motivation will be provided by contacting by phone / call once a week for follow-up.

Other: Hand Therapy as home program

Interventions

Hand Therapy by PhysiotherapistOTHER

stretching exercises; all finger joints, wrist and supination-pronation direction strengthening exercises; finger and wrist functional exercises retrograde massage; starting from the distal phalanx to the elbow sensory education; desentilation training (cotton…) breathing exercises 5 days / week, 8 weeks in total * 3 days / week with physiotherapist * 2 days / week as home program 30 minutes / day 12 repetitions

Also known as: Physiotherapy and Rehabilitation
Physiotherapy Program
Hand Therapy as home programOTHER

stretching exercises; all finger joints, wrist and supination-pronation direction strengthening exercises; finger and wrist functional exercises retrograde massage; starting from the distal phalanx to the elbow sensory education; desentilation training (cotton…) breathing exercises 5 days / week, 8 weeks in total * 3 days / week with physiotherapist * 2 days / week as home program 30 minutes / day 12 repetitions

Also known as: Physiotherapy and Rehabilitation
Home Program

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having been diagnosed with scleroderma
  • Stability of medical treatments
  • To be able to adapt to the exercises

You may not qualify if:

  • The patient has a history of neurological disease or trauma that may affect his symptoms
  • Systemic involvement that affects the treatment process
  • Being in the active phase of the disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tugba Civi Karaaslan

Istanbul, Buyukcekmece, Turkey (Türkiye)

Location

Related Publications (8)

  • Distler O, Cozzio A. Systemic sclerosis and localized scleroderma--current concepts and novel targets for therapy. Semin Immunopathol. 2016 Jan;38(1):87-95. doi: 10.1007/s00281-015-0551-z. Epub 2015 Nov 17.

    PMID: 26577237BACKGROUND

  • Vehe RK, Riskalla MM. Collagen Vascular Diseases: SLE, Dermatomyositis, Scleroderma, and MCTD. Pediatr Rev. 2018 Oct;39(10):501-515. doi: 10.1542/pir.2017-0262. No abstract available.

    PMID: 30275033BACKGROUND

  • Landim SF, Bertolo MB, Marcatto de Abreu MF, Del Rio AP, Mazon CC, Marques-Neto JF, Poole JL, de Paiva Magalhaes E. The evaluation of a home-based program for hands in patients with systemic sclerosis. J Hand Ther. 2019 Jul-Sep;32(3):313-321. doi: 10.1016/j.jht.2017.10.013. Epub 2017 Dec 1.

    PMID: 29198478BACKGROUND

  • Antonioli CM, Bua G, Frige A, Prandini K, Radici S, Scarsi M, Danieli E, Malvicini A, Airo P. An individualized rehabilitation program in patients with systemic sclerosis may improve quality of life and hand mobility. Clin Rheumatol. 2009 Feb;28(2):159-65. doi: 10.1007/s10067-008-1006-x. Epub 2008 Sep 16.

    PMID: 18795394BACKGROUND

  • Lopes AJ, Justo AC, Ferreira AS, Guimaraes FS. Systemic sclerosis: Association between physical function, handgrip strength and pulmonary function. J Bodyw Mov Ther. 2017 Oct;21(4):972-977. doi: 10.1016/j.jbmt.2017.03.018. Epub 2017 Mar 29.

    PMID: 29037654BACKGROUND

  • Mancuso T, Poole JL. The effect of paraffin and exercise on hand function in persons with scleroderma: a series of single case studies. J Hand Ther. 2009 Jan-Mar;22(1):71-7; quiz 78. doi: 10.1016/j.jht.2008.06.009. Epub 2008 Aug 30.

    PMID: 18950987BACKGROUND

  • Rannou F, Boutron I, Mouthon L, Sanchez K, Tiffreau V, Hachulla E, Thoumie P, Cabane J, Chatelus E, Sibilia J, Roren A, Berezne A, Baron G, Porcher R, Guillevin L, Ravaud P, Poiraudeau S. Personalized Physical Therapy Versus Usual Care for Patients With Systemic Sclerosis: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2017 Jul;69(7):1050-1059. doi: 10.1002/acr.23098. Epub 2017 Jun 7.

    PMID: 27696703BACKGROUND

  • Schapira AH, Holt IJ, Sweeney M, Harding AE, Jenner P, Marsden CD. Mitochondrial DNA analysis in Parkinson's disease. Mov Disord. 1990;5(4):294-7. doi: 10.1002/mds.870050406.

    PMID: 1979656BACKGROUND

MeSH Terms

Conditions

Scleroderma, DiffuseScleroderma, Systemic

Interventions

Physical Therapy ModalitiesRehabilitation

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsAftercareContinuity of Patient CarePatient CareHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • TUGBA CIVI KARAASLAN, MSc

    Research Assistant

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Clinical Study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

November 6, 2019

First Posted

November 27, 2019

Study Start

November 21, 2019

Primary Completion

November 21, 2020

Study Completion

January 27, 2021

Last Updated

January 28, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)