The rehabilitation of facial involvement in systemic sclerosis: efficacy of the combination of Kabat's technique, connective tissue massage and kinesitherapy
| ISRCTN | ISRCTN43633950 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43633950 |
| Secondary identifying numbers | N/A |
- Submission date
- 12/12/2008
- 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
Villa Monna Tessa
Viale Pieraccini 18
Florence
50139
Italy
Study information
| Study design | Single-centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | The rehabilitation of facial involvement in systemic sclerosis: efficacy of the combination of Kabat's technique, connective tissue massage and kinesitherapy - a randomised controlled trial |
| Study objectives | Systemic sclerosis is a connective tissue disease characterised by induration of the skin and internal organs, by joint modifications and muscle impairment. Skin fibrosis leads to tissue retraction and atrophy, and consequently to disability and reduction of patients' quality of life. This trial aims to assess the efficacy of a rehabilitation programme based on the combination of Kabat's technique, connective massage and kinesitherapy specifically conceived for the face of systemic sclerosis patients. |
| Ethics approval(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | Systemic sclerosis |
| Intervention | Intervention group: 20 patients treated for 9 weeks (twice a week, 1 hour per session) with a combined face rehabilitation programme (Kabat's technique, connective tissue massage, kinesitherapy and home exercise programme) Control group: 20 patients were assigned only to home exercise programme. All patients were assessed at baseline, end of treatment (after 9 weeks) and after 9 weeks of follow-up. |
| Intervention type | Other |
| Primary outcome measure | The following were assessed at baseline, end of treatment (after 9 weeks) and after 9 weeks of follow-up: 1. Improvement of facial skin score (modified Rodnan Skin Score) 2. Mouth opening (distance in centimetres between the tips of upper and lower right incisive teeth) |
| Secondary outcome measures | The following were assessed at baseline, end of treatment (after 9 weeks) and after 9 weeks of follow-up: 1. Facial systemic sclerosis disability, assessed by the Mouth Handicap In Systemic Sclerosis (MHISS) scale 2. Quality of life, assessed by the 36-item Short Form (SF-36) Health Survey and Health Assessment Questionnaire (HAQ) |
| Overall study start date | 15/02/2007 |
| Completion date | 10/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 40 |
| Key inclusion criteria | 1. Both males and females, no age limits 2. Systemic sclerosis patients fulfilling the American College of Rheumatology (ACR) criteria with facial involvement assessed by a Rodnan skin score greater than or equal to 1 |
| Key exclusion criteria | Does not meet the inclusion criteria |
| Date of first enrolment | 15/02/2007 |
| Date of final enrolment | 10/01/2008 |
Locations
Countries of recruitment
- Italy
Study participating centre
Villa Monna Tessa
Florence
50139
Italy
50139
Italy
Sponsor information
University of Florence (Italy)
University/education
University/education
Department of Medicine
Viale Morgagni, 85
Florence
50134
Italy
| Website | http://www.unifi.it/ |
|---|---|
"ROR" |
https://ror.org/04jr1s763 |
Funders
Funder type
University/education
University of Florence (Italy) - Department of Medicine
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 |
