Condition category
Nervous System Diseases
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
13/07/2009
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

Prof Derick T Wade

ORCID ID

Contact details

Oxford Centre for Enablement
Nuffield Orthopaedic Centre
Windmill Road
Oxford
OX3 7LD
United Kingdom

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 measures

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

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

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

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

Results - basic reporting

Publication summary

2009 pilot study results in http://www.ncbi.nlm.nih.gov/pubmed/19164401

Publication citations

  1. 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.

Additional files

Editorial Notes