Developing better care for the elderly patients with walking disability due to degenerative lumbar spine stenosis

ISRCTN	ISRCTN35836727
DOI	https://doi.org/10.1186/ISRCTN35836727
Protocol serial number	N0626176966
Sponsor	Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Funder	Bradford South and West Primary Care Trust (UK), NHS R&D Support Funding

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Miss Christine Comer
Scientific

Physiotherapy Department
Wharfedale Hospital
Newall Carr Road
Otley
LS21 2LY
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/09/2008

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	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

Wharfedale Hospital

Otley
LS21 2LY
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	30/09/2013	06/01/2021	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

06/01/2021: Publication reference added.