Condition category
Circulatory System
Date applied
12/05/2010
Date assigned
04/03/2011
Last edited
19/06/2015
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 Melanie Brown

ORCID ID

Contact details

National Institute of Conductive Education
Cannon Hill House
Russell Road
Birmingham
B13 8RD
United Kingdom
-
melanie@conductive-education.org.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Conductive education as a method of post-stroke rehabilitation: a randomised controlled trial

Acronym

Study hypothesis

Conductive Education (CE) is a specialised rehabilitation system developed in Hungary in the late 1940s by András Petö. The CE approach is used with adults and children with motor disorders subsequent to neurological damage. CE aims to help stroke survivors to maintain and/or increase range and control of movement, teaching components of everyday skills and strategies that each individual can apply to their daily activities. Functional tasks are broken down into a series of components that are repeatedly and rhythmically practiced with verbal reinforcement ('rhythmical intention'). Task series are designed to allow participants to develop an increased awareness of their own movement and to learn the basic rules of movement solutions which can then be applied through regular daily activity.

Previous research has shown some improvements in stroke survivor's activities of daily living and well-being (Brittle et al., 2008), as well as a reduction in carer burden (Laver & Brown, 1995) following CE intervention. However, no previous study has examined CE outcomes for stroke participants in comparison with a control group. We are therefore examining a broad range of quality of life outcomes across physical, cognitive and psychological domains using a randomised design. We are also measuring carer well-being in relation to CE.

Ethics approval

Birmingham City Council Research Governance Advisory Committee, 02/02/2010

Study design

Single-centre interventional randomised waiting list controlled cross-over trial

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

Stroke rehabilitation

Intervention

The conductive education intervention will be administered as a 1.5 hour session once per week for 10 weeks. Intervention takes place in a small group setting (maximum of 5 participants) led by two conductors. Control (waiting list) participants will attend two introductory sessions during the wait period in which they will receive standard written and visual materials.

All participants will be followed up 3 months after completion of the conductive education programme.

Participants in the waiting list group will be offered intervention after 3 months.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Mobility will be assessed using a timed up and go test and a 10 metre walking test:
The timed up and go test requires participants to stand from a chair, walk forward 3 metres, turn around, return to the chair and sit down. Completion time (in seconds) is recorded. The 10 metre walking test requires the participant to walk forwards 10m at their normal pace, and completion time (seconds) is recorded.
2. Activities of daily living will be measured using the Barthel Index:
A 10 item questionnaire examining activities such as walking and dressing. Higher scores represent greater functional independence.
3. Quality of life will be measured using the Stroke Impact Scale:
A 59-item stroke-specific questionnaire covering 8 domains of well-being. Higher scores indicate better well-being.
4. Participants are also asked to complete the EQ-5D quality of life scale for use in an economic evaluation linked to the study

All measures are taken at baseline (before commencing the intervention/wait period), after 3 months (on completion of the intervention/waiting list period) and at follow up 3 months after intervention. Waiting list participants are also assessed on completion of the CE course.

Secondary outcome measures

1. Cognitive performance will be measured using the following:
1.1. Test of Everyday Attention, which tests selective, sustained and divided attention
2. Wisconsin Card Sorting Test (WCST-64 version), a measure of planning, problem solving and cognitive flexibility.
2. Anxiety and depression will be measured using the Hospital Anxiety and Depression Scale (HADS):
A 14-item questionnaire. Higher scores indicate higher levels of anxiety and depression.
3. Carers will be asked to complete the following at each assessment point:
3.1. SF-36, a general health-related quality of life measure
3.2. HADS

All measures are taken at baseline (before commencing the intervention/wait period), after 3 months (on completion of the intervention/waiting list period) and at follow up 3 months after intervention. Waiting list participants are also assessed on completion of the CE course.

Overall trial start date

01/04/2010

Overall trial end date

31/07/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Individuals who have suffered a stroke and are in the post-acute stage of recovery
2. Participants should be medically well enough to follow the programme and be capable of giving informed consent.
3. Male or female, age ≥ 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

The total target sample size is 120. Participants will be recruited in cohorts of 20; 10 of each cohort will be allocated to immediate intervention and 10 to the waiting list control group.

Participant exclusion criteria

1. Individuals who are medically unfit to participate or unable to give informed consent
2. Participants must not be receiving regular physiotherapy input

Recruitment start date

01/04/2010

Recruitment end date

31/07/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

National Institute of Conductive Education
Birmingham
B13 8RD
United Kingdom

Sponsor information

Organisation

Birmingham City Council (UK) - Adults and Communities

Sponsor details

Birmingham Social Services
Level 5
Louisa Ryland House
44 Newhall Street
Birmingham
B3 3PL
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Birmingham City Council (UK) - Department of Health Stroke Care Grant (May 2009)

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