Efficacy of the association of district specific and global rehabilitative techniques tailored for systemic sclerosis (SSc) patients
| ISRCTN | ISRCTN54093934 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54093934 |
| Secondary identifying numbers | N/A |
- Submission date
- 15/12/2008
- Registration date
- 23/12/2008
- Last edited
- 23/12/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Susanna Maddali Bongi
Scientific
Scientific
Viale Pieraccini 18
Florence
50139
Italy
Study information
| Study design | Randomised controlled single centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | The rehabilitation of systemic sclerosis: efficacy of the association of district specific and global rehabilitative techniques - a randomised controlled trial |
| Study objectives | Systemic sclerosis (SSc) is a systemic disease affecting the microvascular system and the connective tissue, causing important alterations of skin and internal organs and impairing the function of the heart, lung, kidney and peripheral nervous system. In SSc, the most important rehabilitative problems arise from skin induration and joint and muscle involvement often insufficiently responsive to a merely pharmacological approach. In fact, involvement of skin with progressive tissue fibrosis and retraction is a major condition of disability. This trial aims to assess the short- and mid-term efficacy of an individualised rehabilitation programme specifically conceived and tailored for SSc and to set the basis of a specific rehabilitative approach to this chronic disease. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Systemic sclerosis (SSc) |
| Intervention | 20 SSc patients were enrolled and randomly assigned to Group A or Group B: Group A (10 patients) was treated for a 9-week period (twice a week, 1 hour per session) with an individualised rehabilitation program whose composition partially differed from patient to patient on the basis of involved districts and patient's expectations. All patients were treated with hand and face rehabilitation. Hand lymphatic drainage and global methods such as aquatic and land-based global rehabilitation, also comprising respiratory exercises, and Rességuier method were added when necessary. Group B (10 patients) was the observational group, provided with education advices and medical information about SSc. |
| Intervention type | Other |
| Primary outcome measure | Improvement in disability and quality of life, assessed by the 36-item Short Form (SF-36) Health Survey and the Health Assessment Questionnaire (HAQ). |
| Secondary outcome measures | Hand and face involvement: 1. Hand Mobility in Scleroderma (HAMIS) test 2. Cochin Functional Hand Scale 3. Water Volumetric Test 4. Mouth functionality 5. Hand range of motion |
| Overall study start date | 01/04/2007 |
| Completion date | 20/04/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 20 |
| Key inclusion criteria | 1. Diagnosis of systemic sclerosis according to the American College of Rheumatology (ACR) criteria 2. Facial skin score greater than 1 3. SSc hand involvement 4. No age limits |
| Key exclusion criteria | Does not meet the inclusion criteria |
| Date of first enrolment | 01/04/2007 |
| Date of final enrolment | 20/04/2008 |
Locations
Countries of recruitment
- Italy
Study participating centre
Viale Pieraccini 18
Florence
50139
Italy
50139
Italy
Sponsor information
Italian Association for the Study of Systemic Sclerosis and Fibrotic Diseases (ASSMaF) (Italy)
Research organisation
Research organisation
Viale Pieraccini 18
Florence
50139
Italy
| Website | http://www.assmaf.org |
|---|---|
"ROR" |
https://ror.org/00feyy410 |
Funders
Funder type
Research organisation
Italian Association for the Study of Systemic Sclerosis and Fibrotic Diseases (ASSMaF) (Italy)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
