Condition category
Circulatory System
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
07/04/2010
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

Dr A J Turton

ORCID ID

Contact details

Burden Neurological Institute
North Bristol NHS Trust
Frenchay Hospital
Bristol
BS16 1ND
United Kingdom
+44 (0)117 970 1212
ailee@elecdesn.demon.co.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0234077966

Study information

Scientific title

Acronym

Study hypothesis

1. To evaluate the effectiveness of a daily stretch regime in the prevention of muscle stiffness and contracture in the affected arm of patients following stroke
2. To evaluate the acceptability and compliance of a new ward based stretch regime
3. To gain a better understanding of the natural history of the development of muscle stiffness and its relation to reflex hyperexcitability

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

Stroke

Intervention

Randomised controlled trial:
1. To evaluate the effectiveness of a daily stretch regime in the prevention of muscle stiffness and contracture in the affected arm of patients following stroke
2. To evaluate the acceptability and compliance of a new ward based stretch regime
3. To gain a better understanding of the natural history of the development of muscle stiffness and its relation to reflex hyperexcitability

In addition to usual care, subjects in the experimental group were prescribed two 30-min stretches for wrist and finger flexors and two 30-min stretches targeting shoulder adductors and internal rotators, per day for up to 12 weeks post stroke. Stretches were carried out by therapists and nursing staff.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Measured at four, eight and twelve weeks after stroke:
1. Range of movement
2. Resistance to passive movement
3. Pain
4. Motor recovery
5. Activities of Daily Living (ADL)

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/01/2001

Overall trial end date

31/12/2003

Reason abandoned

Eligibility

Participant inclusion criteria

200 adults over 18, mostly elderly.

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

200

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/2001

Recruitment end date

31/12/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Burden Neurological Institute
Bristol
BS16 1ND
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 Bristol 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

2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16180595

Publication citations

  1. Results

    Turton AJ, Britton E, A pilot randomized controlled trial of a daily muscle stretch regime to prevent contractures in the arm after stroke., Clin Rehabil, 2005, 19, 6, 600-612.

Additional files

Editorial Notes