A study to investigate whether provision of a short term, exercise and education programme for adults with acquired brain and spinal cord pathology will lead to an increase in levels of independent activity and self efficacy for exercise behaviours.

ISRCTN	ISRCTN95746400
DOI	https://doi.org/10.1186/ISRCTN95746400
Secondary identifying numbers	N0259142786

Submission date: 30/09/2005
Registration date: 30/09/2005
Last edited: 09/09/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Miss Joanne Haworth
Scientific

The Walton Centre for Neurology and Neurosurgery
Lower Lane
Fazakerley
Liverpool
L9 7LJ
United Kingdom

Study information

Study design	Randomised single blind placebo controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Other
Scientific title
Study objectives	To examine whether undertaking a physiotherapy led exercise and education programme will increase confidence to carry out exercise independently and improve levels of daily activity in those patients with acquired brain and spinal cord pathologies.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Brain diseases
Intervention	The study will be randomised, single blind, placebo controlled experimental trial. Appropriate participants will be subject to random sampling following consent and then assigned to either a treatment group or control group. The intervention to be examined includes a short, exercise and education programme undertaken immediately on discharge from hospital. The development of this programme followed discussions with various in patients receiving rehabilitation following brain and spinal cord injury surrounding their concerns for ongoing exercise and activity when they are at home. Both the treatment and control groups will undertake the standard discharge procedures of follow-up clinic reviews and referral to out patient physiotherapy as appropriate. The treatment group will also receive the intervention. Validation outcome measures will be utilised to measure the effects of the intervention. Following data collection, the information will be subject to statistical analysis and the results reported. A pilot study will be undertaken to review the appropriateness of the chosen methodology.
Intervention type	Other
Primary outcome measure	1. Exercise Self Efficacy Measure - Paper containing measure on order from library. 2. Human Activity Profile - Questionnaire on activity levels.
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/08/2004
Completion date	01/06/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	44 (added 09/09/09)
Key inclusion criteria	1. Disorder of movement caused by brain or spinal cord pathology. 2. Ability to carry out independent exercise. 3. Physical level which includes independent sitting balance and transfer ability. 4. Able to exercise safely without constant supervision. 5. Age 16-65.
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	01/08/2004
Date of final enrolment	01/06/2006

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

The Walton Centre for Neurology and Neurosurgery

Liverpool
L9 7LJ
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

The Walton Centre for Neurology and Neurosurgery NHS Trust (UK)

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	01/04/2009		Yes	No