Condition category
Nervous System Diseases
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
09/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss Joanne Haworth

ORCID ID

Contact details

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

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 measures

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

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

http://www.dh.gov.uk/Home/fs/en

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

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19293292

Publication citations

  1. 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.

Additional files

Editorial Notes