Condition category
Nervous System Diseases
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
12/09/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss Karen Baker

ORCID ID

Contact details

Physical Disability Support Team
North West London Hospitals NHS Trust
P Block Northwick Park Hospital
Watford Road
Harrow
HA1 3UJ
United Kingdom
+44 (0)20 8869 3636

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 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes