Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0515143146
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/05/2004
Overall trial end date
01/05/2005
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
6
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/05/2004
Recruitment end date
01/05/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Physical Disability Support Team
Harrow
HA1 3UJ
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
North West London Hospitals NHS Trust (UK) - NHS R&D Support Funding
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