Developing stroke care for adults in the community: rehabilitation through conductive education
| ISRCTN | ISRCTN84064492 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84064492 |
| Secondary identifying numbers | N/A |
- Submission date
- 12/05/2010
- Registration date
- 04/03/2011
- Last edited
- 09/11/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Melanie Brown
Scientific
Scientific
National Institute of Conductive Education
Cannon Hill House
Russell Road
Birmingham
B13 8RD
United Kingdom
| melanie@conductive-education.org.uk |
Study information
| Study design | Single-centre interventional randomised waiting list controlled cross-over trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
| Scientific title | Conductive education as a method of post-stroke rehabilitation: a randomised controlled trial |
| Study objectives | 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(s) | Birmingham City Council Research Governance Advisory Committee, 02/02/2010 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/04/2010 |
| Completion date | 31/07/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | 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. |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/04/2010 |
| Date of final enrolment | 31/07/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
National Institute of Conductive Education
Birmingham
B13 8RD
United Kingdom
B13 8RD
United Kingdom
Sponsor information
Birmingham City Council (UK) - Adults and Communities
Government
Government
Birmingham Social Services
Level 5, Louisa Ryland House
44 Newhall Street
Birmingham
B3 3PL
United Kingdom
"ROR" |
https://ror.org/04dm6ed68 |
|---|
Funders
Funder type
Government
Birmingham City Council (UK) - Department of Health Stroke Care Grant (May 2009)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2016 | Yes | No |
Editorial Notes
09/11/2017: Publication reference added.
