Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0259142786
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised single blind placebo controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Other
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
01/08/2004
Overall trial end date
01/06/2006
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
44 (added 09/09/09)
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/08/2004
Recruitment end date
01/06/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Walton Centre for Neurology and Neurosurgery
Liverpool
L9 7LJ
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
The Walton Centre for Neurology and Neurosurgery NHS Trust (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
Basic results (scientific)
Publication list
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19293292
Publication citations
-
Results
Haworth J, Young C, Thornton E, The effects of an 'exercise and education' programme on exercise self-efficacy and levels of independent activity in adults with acquired neurological pathologies: an exploratory, randomized study., Clin Rehabil, 2009, 23, 4, 371-383, doi: 10.1177/0269215508101728.