Condition category
Musculoskeletal Diseases
Date applied
15/12/2008
Date assigned
23/12/2008
Last edited
23/12/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Susanna Maddali Bongi

ORCID ID

Contact details

Viale Pieraccini 18
Florence
50139
Italy

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The rehabilitation of systemic sclerosis: efficacy of the association of district specific and global rehabilitative techniques - a randomised controlled trial

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled single centre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/04/2007

Overall trial end date

20/04/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

20

Participant exclusion criteria

Does not meet the inclusion criteria

Recruitment start date

01/04/2007

Recruitment end date

20/04/2008

Locations

Countries of recruitment

Italy

Trial participating centre

Viale Pieraccini 18
Florence
50139
Italy

Sponsor information

Organisation

Italian Association for the Study of Systemic Sclerosis and Fibrotic Diseases (ASSMaF) (Italy)

Sponsor details

Viale Pieraccini 18
Florence
50139
Italy

Sponsor type

Research organisation

Website

http://www.assmaf.org

Funders

Funder type

Research organisation

Funder name

Italian Association for the Study of Systemic Sclerosis and Fibrotic Diseases (ASSMaF) (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes