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
Secondary identifying numbers	N0515143146

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

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

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
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	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/05/2004
Completion date	01/05/2005

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	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

England
United Kingdom

Study participating centre

Physical Disability Support Team

Harrow
HA1 3UJ
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

North West London Hospitals NHS Trust (UK) - NHS R&D Support Funding

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