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
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