Mental techniques and stretching in spasticity - A randomised controlled trial
| ISRCTN | ISRCTN91180703 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91180703 |
| Protocol serial number | N0176189947 |
| Sponsor | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Funder | Oxford Radcliffe Hospitals NHS Trust (UK) |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Oxford Centre for Enablement
Nuffield Orthopaedic Centre
Windmill Road
Oxford
OX3 7LD
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
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. |
| Key secondary outcome measure(s) |
Change from baseline to 9 and 12 weeks in: |
| Completion date | 01/08/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
OX3 7LD
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
