Condition category
Circulatory System
Date applied
14/01/2014
Date assigned
29/01/2014
Last edited
29/01/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Andrew Soundy

ORCID ID

Contact details

School of Sport
Exercise and Rehabilaition Sciences
University of Birmingham
Birmingham
B15 2TT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2.0

Study information

Scientific title

The psychosocial Benefits of an Innovative Community-university Rehabilitation programme for Individuals who have suffered a Stroke: a controlled trial

Acronym

BICRIS

Study hypothesis

The specialist supported rehabilitation setting will provide greater improvements in an individual’s self-efficacy.

Ethics approval

University of Birmingham Ethics Committee, 02/12/2013, ref.: ERN_13-1091

Study design

Quasi-experimental controlled trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

15/01/2014

Overall trial end date

15/01/2015

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

72

Participant 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.

Recruitment start date

15/01/2014

Recruitment end date

15/01/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Sport, Exercise and Rehabilaition Sciences
Birmingham
B15 2TT
United Kingdom

Sponsor information

Organisation

University of Birmingham (UK)

Sponsor details

C/O Dr A Soundy
Director Action After Stroke
School of Sport
Exercise and Rehabiliation Sciences
Birmingham
B15 2TT
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Action After Stroke (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

Publication citations

Additional files

Editorial Notes