The effect of abdominal massage on the bowel habit of adults with cerebral palsy
| ISRCTN | ISRCTN01372570 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN01372570 |
| Secondary identifying numbers | PCC106X |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 24/10/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Ms Marian Emly
Scientific
Scientific
Meanwood Park Hospital
Physiotherapy Department
Tongue Lane
Leeds
LS6 4QB
United Kingdom
| Phone | +44 (0)113 275 8721 |
|---|---|
| abc@email.com |
Study information
| Study design | Randomised cross-over design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | The effect of abdominal massage on the bowel habit of adults with cerebral palsy |
| Study hypothesis | Adults with complex physical and learning disabilities frequently experience chronic constipation. The standard treatment is a combination of laxative and enema use. This does not always prove a satisfactory form of management and the inappropriate use of these drugs can cause colonic atony and other side effects. It has been suggested that abdominal massage, a safe and non-invasive technique, may provide an effective alternative. This study will measure gastro-intestinal transit time in this population and assess the relative effect on it of both massage and laxatives. Stool consistency, the requirement for enemas and patient well-being will also be assessed in order to evaluate the comparative merits of each treatment. The study population of approximately 36 adults will be drawn from residents of Meanwood Park Hospital who have cerebral palsy/abnormal muscle tone and who have been on regular laxative medication for over 12 months. Although the study group will vary in age, sex, level of mobility and drug management, a randomised cross-over design has been chosen to take account of patient heterogeneity by using intra-subject comparisons. If clinically proven, abdominal massage has the potential to contribute to safer and more effective practice in bowel management. Other benefits could include increased patient well-being, enhanced by the greater staff/carer involvement in their management, and the possible reduction in the requirement for laxatives. The value of this therapy could extend beyond the client group to be studied, and benefit a variety of patients who present with chronic constipation. |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Nervous system diseases: cerebral palsy |
| Intervention | 1. Abdominal massage 2. Regular laxative treatment |
| Intervention type | Other |
| Primary outcome measure | Bowel management and patient well-being |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 18/09/1995 |
| Overall study end date | 05/10/1996 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 36 |
| Participant inclusion criteria | Residential patients with cerebral palsy/abnormal muscle tone and who have been on regular laxative medication for over 12 months. |
| Participant exclusion criteria | Not provided at time of registration |
| Recruitment start date | 18/09/1995 |
| Recruitment end date | 05/10/1996 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Meanwood Park Hospital
Leeds
LS6 4QB
United Kingdom
LS6 4QB
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive Northern and Yorkshire (UK)
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 |
Editorial Notes
24/10/2019: No publications found. All search options exhausted.
