Developing better care for the elderly patients with walking disability due to degenerative lumbar spine stenosis
ISRCTN | ISRCTN35836727 |
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DOI | https://doi.org/10.1186/ISRCTN35836727 |
Secondary identifying numbers | N0626176966 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 06/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal 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 Christine Comer
Scientific
Scientific
Physiotherapy Department
Wharfedale Hospital
Newall Carr Road
Otley
LS21 2LY
United Kingdom
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Quality of life |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | Developing better care for the elderly patients with walking disability due to degenerative lumbar spine stenosis |
Study objectives | Not provided at time of registration |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Musculoskeletal Diseases: Degenerative lumbar spine stenosis |
Intervention | Walking tolerance will be measured with and without a stick. |
Intervention type | Other |
Primary outcome measure | Shuttle walking crossover test: difference in walking tolerance (measured in metres) between SWT with walking stick and SWT without walking stick. Each shuttle is 10 metres, thus the number of completed shuttles counted by the investigator will be multiplied by 10 to provide an outcome measure in metres. |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/01/2006 |
Completion date | 01/09/2008 |
Eligibility
Participant type(s) | Patient |
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Age group | Senior |
Sex | Both |
Target number of participants | 20 |
Key inclusion criteria | 1. Patients 65 and over 2. Unilateral or bilateral neurogenic claudication (NC), ie exercise induced leg pain on walking, relieved in sitting 3. Patient reported limitation of walking tolerance due to symptoms of NC |
Key exclusion criteria | 1. Cognitive impairment preventing full understanding or participation in the study 2. Evidence of medical conditions such as hip/leg pathology or peripheral vascular disease, which may mimic NC or prevent participation in a shuttle walking test 3. Severe or worsening neurological status 4. Signs/symptoms of cauda equina compression, inflammatory joint disease, signs/symptoms of sinister pathology (unexplained weight loss, unremitting/night-time pain, history of cancer), which may require urgent surgical opinion. This will be determined through subjective and objective examination of patients by the recruiting researcher at the point of screening 5. Exclusion criterion for Home Trial Pilot phase only: previous use of walking aid |
Date of first enrolment | 01/01/2006 |
Date of final enrolment | 01/09/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Wharfedale Hospital
Otley
LS21 2LY
United Kingdom
LS21 2LY
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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dhmail@doh.gsi.org.uk | |
Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Bradford South and West Primary Care Trust (UK), NHS R&D Support Funding
No information available
Results and Publications
Intention to publish date | |
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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 | 30/09/2013 | 06/01/2021 | Yes | No |
Editorial Notes
06/01/2021: Publication reference added.