Mental techniques and stretching in spasticity - A randomised controlled trial
| ISRCTN | ISRCTN91180703 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91180703 |
| Secondary identifying numbers | N0176189947 |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 13/07/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Derick T Wade
Scientific
Scientific
Oxford Centre for Enablement
Nuffield Orthopaedic Centre
Windmill Road
Oxford
OX3 7LD
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 1. Stiffness of limbs, with marked weakness is common in people with neurological disease. This can cause pain, discomfort, and significant difficulty in carrying out personal activities such as dressing (or having them done by a carer). Treatment using therapy and drugs is not very effective. The first treatment used is to stretch the affected muscle or joint. We wish to discover whether this can be made more effective, easier and less uncomfortable by asking the person to practice the movement in their mind (imagination) even though they cannot do it. We will compare 'mental practice' with simply relaxing. 2. If the technique does work with a therapist, to discover whether the person can continue to use it effectively with carers after the treatment phase. Also: to gain an estimate as to the size of any benefit so that a full trial can be undertaken if necessary and appropriate. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Nervous System Diseases: Spasticity |
| Intervention | 1. One group will be taught to relax using relaxation techniques such as breathing 2. The other group will be taught to practice mentally stretching the affected muscles |
| Intervention type | Other |
| Primary outcome measure | 1. The primary patient outcome measure will be the change in the numerical scale rating of pain/discomfort experienced during the passive stretch of the selected limb/muscle group, this rating being 0-11, this change being calculated from the baseline to the assessment at 9 weeks. 2. The primary external outcome measure will be the change in the numerical scale rating of the difficulty of undertaking the stretch of the selected limb/muscle group, this rating being 0-11, this change being calculated from the baseline to the assessment at 9 weeks. |
| Secondary outcome measures | Change from baseline to 9 and 12 weeks in: 1. Modified Ashworth Scale measure of spasticity applied to the selected joint 2. Degrees of stretch achieved measured using a goniometer 3. Time taken to achieve 30 degrees of change in joint angle measured in seconds |
| Overall study start date | 01/08/2006 |
| Completion date | 01/08/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 20 |
| Key inclusion criteria | Participants will be recruited from consultant neurologists if they have a neurological condition, are aged 18 years and over and have a stiff muscle group that needs regular stretching to prevent deterioration and /or to reduce existing problems (such as difficulty in being dressed). |
| Key exclusion criteria | No specific exclusion criteria. |
| Date of first enrolment | 01/08/2006 |
| Date of final enrolment | 01/08/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Oxford Centre for Enablement
Oxford
OX3 7LD
United Kingdom
OX3 7LD
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
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.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Oxford Radcliffe Hospitals NHS Trust (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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | pilot study results | 01/02/2009 | Yes | No |
