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
Protocol serial number	N/A
Sponsor	University of Florence (Italy)
Funder	University of Florence (Italy) - Department of Medicine

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

Villa Monna Tessa
Viale Pieraccini 18
Florence
50139
Italy

Study information

Primary study design	Interventional
Study design	Single-centre randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	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)
Key secondary outcome measure(s)	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)
Completion date	10/01/2008

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan