Condition category
Skin and Connective Tissue Diseases
Date applied
04/05/2020
Date assigned
22/05/2020
Last edited
22/05/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
Systemic sclerosis is characterized by stiffness and contraction of tissues such as the skin, caused by the dominant pathologic feature called fibrosis, which leads to decreased tissue function and to a limitation in the execution of daily activities. The aim the our study was to investigate the impact of a specialized physiotherapy/occupational therapy program focused on the function of the hands and face and quality of life.

Who can participate?
Adults over 18 years, with systemic sclerosis and skin involvement at least of the fingers/hands and the face.

What does the study involve?
Participants will be randomly allocated to receive either treatment as usual or an additional six month program twice a week consisting of supervised physiotherapy (1 hour) and occupational therapy (0.5 hour) focused on the function of hands and face.

What are the possible benefits and risks of participating?
None

Where is the study run from?
Institute of Rheumatology (Czech Republic)

When is the study starting and how long is it expected to run for?
January 2015 to June 2017

Who is funding the study?
Ministry of Health Czech Republic

Who is the main contact?
Dr Michal Tomcik, tomcik@revma.cz

Trial website

Contact information

Type

Scientific

Primary contact

Dr Michal Tomcik

ORCID ID

http://orcid.org/0000-0002-8616-7850

Contact details

Institute of Rheumatology
Na Slupi 4
Prague
12850
Czech Republic
+420 (0)234075101
tomcik@revma.cz

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Effectiveness of specialized hand/face physical-occupational therapy in patients with systemic sclerosis

Acronym

RHB-SSc

Study hypothesis

Our specialized, long-term, tailored, physiotherapy/occupational therapy program focused on hand and face involvement in systemic sclerosis patients improves the function of hands/face, disability, quality of life (compared to controls treated with the standard of care).

Ethics approval

Approved 29/07/2014, Ethics Committee of the Institute of Rheumatology Prague (Ethics Committee of Institute of Rheumatology Prague, Na Slupi 4, 128 50 Praha 2, Czech Republic; +420 234075244; putova@revma.cz), ref: 1446/2014

Study design

interventional single-centre prospective non-randomized controlled study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Systemic sclerosis/scleroderma

Intervention

Control group: standard of care (i.e. standard pharmacological treatment according to the EULAR/ACR recommendations on the management of systemic sclerosis, education, and materials for regular daily home exercise)
Intervention group: standard of care (as described above) + 6 months of specialized intervention program twice a week consisting of supervised physiotherapy (1 hour) and occupational therapy (0.5 hour) focused on the function of hands and face

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Measured at baseline, week 12, week 24, week 48:
1. Function of the hands assessed by:
- HAMIS test (Hand Mobility in Scleroderma)
- delta finger to palm distance
- hand grip strength measured by dynamometry
- CHFS questionnaire (Cochin Hand Function Scale)
2. Function of the face:
- inter-lip and inter-incisor distance
- MHISS questionnaire (Mouth Handicap in Systemic Sclerosis)

Secondary outcome measures

Measured at baseline, week 12, week 24, week 48:
1. Assessment of health/disability:
- HAQ questionnaire (Health Assessment Questionnaire)
- SHAQ questionnaire (Scleroderma Health Assessment Questionnaire)
2. Quality of life:
- SF-36 questionnaire (Medical Outcomes Short Form-36)

Overall trial start date

01/05/2014

Overall trial end date

30/06/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Informed consent form signed and dated
2. Reliable and capable of adhering to the protocol and visit schedule
3. At least 18 years of age
4. Fulfilled the 2013 EULAR/ACR classification criteria for systemic sclerosis
5. Skin involvement at least of the fingers/hands and the face
6. Regularly followed at our out-patient department and adheres to the standard-of-care pharmacological therapy indicated by his treating rheumatologist
7. Willing to participate in the study and undergo all planned examinations

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

25 patients in the intervention group and 25 patients in the control group

Total final enrolment

59

Participant exclusion criteria

Subject has any other condition, including medical or psychiatric, which in the investigator's judgment would make the subject unsuitable for inclusion in the study

Recruitment start date

01/01/2015

Recruitment end date

01/04/2016

Locations

Countries of recruitment

Czech Republic

Trial participating centre

Institute of Rheumatology
Na Slupi 4
Prague
12850
Czech Republic

Sponsor information

Organisation

Revmatologický ústav

Sponsor details

(Institute of Rheumatology)
Na Slupi 4
Prague
12850
Czech Republic
+420 (0)234075244
pavelka@revma.cz

Sponsor type

Hospital/treatment centre

Website

http://www.revma.cz/en

Funders

Funder type

Government

Funder name

Ministry of Health Czech Republic grant nr. 16-33574A

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Project for Conceptual Development for the institution of Ministry of Health Czech Republic—Institute of Rheumatology (number 023728)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planning to publish the results in a rheumatology-oriented peer-reviewed journal with impact factor.

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date.

Intention to publish date

31/12/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

05/05/2020: Trial’s existence confirmed by Ethics Committee of the Institute of Rheumatology Prague.