Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0176189947
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measure
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.
2. The primary external outcome measure will be the change in the numerical scale rating of the difficulty of undertaking the 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.
Secondary outcome measures
Change from baseline to 9 and 12 weeks in:
1. Modified Ashworth Scale measure of spasticity applied to the selected joint
2. Degrees of stretch achieved measured using a goniometer
3. Time taken to achieve 30 degrees of change in joint angle measured in seconds
Overall trial start date
01/08/2006
Overall trial end date
01/08/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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).
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
20
Participant exclusion criteria
No specific exclusion criteria.
Recruitment start date
01/08/2006
Recruitment end date
01/08/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Oxford Centre for Enablement
Oxford
OX3 7LD
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Oxford Radcliffe Hospitals NHS Trust (UK)
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
Basic results (scientific)
Publication list
2009 pilot study results in http://www.ncbi.nlm.nih.gov/pubmed/19164401
Publication citations
-
Pilot study results
Bovend'Eerdt TJ, Dawes H, Sackley C, Izadi H, Wade DT, Mental techniques during manual stretching in spasticity--a pilot randomized controlled trial., Clin Rehabil, 2009, 23, 2, 137-145, doi: 10.1177/0269215508097298.