A Preliminary Investigation Into The Effect Of Home Standing Programs On Lower Limb Spasticity, Spasm, Pain and Well-being For Individuals With Progressive Multiple Sclerosis (MS)
| ISRCTN | ISRCTN34844778 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34844778 |
| Protocol serial number | N0515143146 |
| Sponsor | Department of Health |
| Funder | North West London Hospitals NHS Trust (UK) - NHS R&D Support Funding |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 12/09/2013
- 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 of protocol
Not provided at time of registration
Contact information
Miss Karen Baker
Scientific
Scientific
Physical Disability Support Team
North West London Hospitals NHS Trust
P Block Northwick Park Hospital
Watford Road
Harrow
HA1 3UJ
United Kingdom
| Phone | +44 (0)20 8869 3636 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | The principal research questions are that daily standing in a frame will: 1. Decrease passive resistance to movement in lower limb (lower limb stiffness know as hyper tonicity) 2. Enhance range of motion at ankles. 3. Decrease frequency of lower limb spasms. 4. Lead to self-reported decrease in pain. 5. Lead to self-reported improvement in well-being. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Nervous System Diseases: Multiple sclerosis (MS) |
| Intervention | The study proposed to use a crossover design of a minimum of six participants with primary or secondary MS these participants will be randomly selected to either a three-week exercise group or a three week standing group. The participants in the standing group will stand daily in a Standing Frame for 30 minutes if able. These participants will be shown how to use and stand in the frame, given exercises to perform whilst standing and show how to correctly position themselves in the frame. Preliminary research results will be feedback to the participants at the end of the six week study period. They will also be informed that final results will be available from the researchers , and the local MS society will also be made aware of the results. Measurements will be taken at assessment, three and six weeks, with the groups crossing over after three weeks. |
| Intervention type | Other |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/05/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 6 |
| Key inclusion criteria | Participants are to be identified from clinical team members (physiotherapists) working in either Harrow PCT, Northwick Park Hospital or Harrow MS Therapy Centre. |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/05/2004 |
| Date of final enrolment | 01/05/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Physical Disability Support Team
Harrow
HA1 3UJ
United Kingdom
HA1 3UJ
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 |
