A rehabilitation programme for individuals who have suffered a stroke
| ISRCTN | ISRCTN52813039 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52813039 |
| Secondary identifying numbers | 2.0 |
- Submission date
- 14/01/2014
- Registration date
- 29/01/2014
- Last edited
- 09/02/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Physiotherapy-led rehabilitation support is beneficial for people who have had a stroke. However, people require a longer duration of rehabilitation than is provided by an NHS hospital. This study will consider a specialist physiotherapy-led exercise program for people in the community who have had a stroke. The aim of this study is to find out if a specialist physiotherapy-led exercise program for people who have had a stroke is beneficial for their physical and psychological well-being.
Who can participate?
People living in the Birmingham area who have had a stroke.
What does the study involve?
An independent physiotherapist will allocate the participants to either a specialist-supported exercise program or to a control group. The exercise group will be supported by physiotherapy students who will guide them through an exercise program devised by a specialist neurological physiotherapist. The individuals in the control group will not receive any treatment. However, once the study is completed the individuals in the control group will be offered the chance to participate in the same exercise program.
What are the possible benefits and risks of participating?
Participants will likely benefit in many ways from improved psychological and physical well-being.
The risks are considered to be minimal.
Where is the study run from?
We hope to recruit around 70 people who have had a stroke from the Birmingham and Solihull boroughs. This will provisionally be from the Stroke Association Centres in Birmingham.
When is the study starting and how long is it expected to run for?
The study will begin in January 2014 and is expected to run for a year.
Who is funding the study?
The charity Action After Stroke, UK.
Who is the main contact?
Dr A Soundy
Contact information
Scientific
School of Sport, Exercise and Rehabilaition Sciences
University of Birmingham
Birmingham
B15 2TT
United Kingdom
Study information
| Study design | Quasi-experimental controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The psychosocial Benefits of an Innovative Community-university Rehabilitation programme for Individuals who have suffered a Stroke: a controlled trial |
| Study acronym | BICRIS |
| Study objectives | The specialist supported rehabilitation setting will provide greater improvements in an individuals self-efficacy. |
| Ethics approval(s) | University of Birmingham Ethics Committee, 02/12/2013, ref.: ERN_13-1091 |
| Health condition(s) or problem(s) studied | Stroke |
| Intervention | An independent physiotherapist provides study details and assigns individuals to groups. This study is non-randomised due to resource limitations and access. Control group: no treatment Experimental group: the experimental group will take place within the University of Birmingham, in accordance with our earlier work (Soundy et al., 2013) and supported by the charity Action After Stroke. This gives individuals with a stroke access to a private hall space, a private fitness suite and when they are ready transitions them to the Inclusive Fitness Facility (IFI) Gym at the University of Birmingham (see http://www.efds.co.uk/inclusive_fitness/ifi_gyms). This gym has been used in our previous research for individuals with neurological disorders (Meek et al., 2012; Elsworth et al., 2011). |
| Intervention type | Other |
| Primary outcome measure | Stroke self-efficacy (Jones et al., 2008), questionnaire measured by a blind assessor at two time points (at baseline and at 11 and 22 weeks). |
| Secondary outcome measures | 1. Social identification measure (Postmes et al., 2013). 2. A 7-item falls efficacy questionnaire (Kempen et al., 2007) 3. 10-meter walk and reach and grasp Outcomes will be measured by a blind assessor at two time points (at baseline and at 11 and 22 weeks). |
| Overall study start date | 15/01/2014 |
| Completion date | 15/01/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | Both |
| Target number of participants | 72 |
| Key inclusion criteria | Participants: Seventy two (36 in each group) individuals from the community that have been diagnosed as having a stroke will be included. Individuals will be selected from a sample within the Birmingham area including South Birmingham and Solihull borough. Individuals will be referred to the study by different charities including the Stroke Association, Different Strokes Charity, conductive education or referred by another related charitable organisation and local stroke support groups. We will not recruit from NHS sources. Inclusion Criteria 1. Individuals must have been diagnosed with a stroke (DOH, 2010). 2. Either gender, age range 18-100 years old |
| Key exclusion criteria | 1. Individuals who are experiencing acute mental health symptoms or that are medically unstable will also be excluded 2. Individuals who are currently involved in a physical activity, behavioural or nutritional research trial 3. Individuals who are currently undertaking exercise within a group or within the community on more than one day a week. |
| Date of first enrolment | 15/01/2014 |
| Date of final enrolment | 15/01/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Birmingham
Birmingham
B15 2TT
United Kingdom
Sponsor information
University/education
C/O Dr A Soundy
Director Action After Stroke
School of Sport, Exercise and Rehabiliation Sciences
Birmingham
B15 2TT
England
United Kingdom
"ROR" |
https://ror.org/03angcq70 |
|---|
Funders
Funder type
Charity
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 | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Andrew Soundy A.A.Soundy@bham.ac.uk |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2016 | Yes | No |
Editorial Notes
09/02/2017: Publication reference added.
