Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0203121474
Study information
Scientific title
Acronym
Study hypothesis
As limited joint movement does not affect the joints directly but rather the soft tissues surrounding them, we hypothesise that mobilisation techniques may prevent some of the destructive, pathomechanical forces initiated by joint limitation.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Nutritional, Metabolic, Endocrine: Diabetes
Intervention
A pilot pragmatic, randomised control trial will be undertaken to assess the effect of teaching stretching exercises to patients with limited joint movement. The primary outcomes will be the improvement in the range of movement and a reduction in the peak plantar pressure.
Measurement of range of movement and plantar pressure will be taken monthly; 50% of recruits will be required to follow a set exercise programme twice weekly, for a total of 12 weeks.
Patients will be contacted fortnightly to monitor progress.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
This is a pilot study that aims to provide preliminary data to test the hypothesis that regular stretching exercises of the foot and ankle will reduce the risk of ulceration in diabetic, neuropathic feet by improving the range of movement of the ankle and hence lower peak plantar pressures. We will evaluate using a randomised control study of a home treatment plan where diabetic patients with neuropathy and limited joint mobility are taught to use regular stretching exercises.
Study endpoints: To assess if this treatment (compared to no treatment):
1. Increases the range of movement at the ankle joint
2. Reduces peak plantar pressure
Secondary outcome measures
Not provided at time of registration
Overall trial start date
27/01/2003
Overall trial end date
31/10/2003
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Diabetic subjects attending the Diabetes and Vascular Centre and local chiropody clinics will be considered for the trial
2. Over 35 years of age
3. Diabetes mellitus
4. Peripheral sensory neuropathy
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
1. Arthritic conditions (e.g., osteo/rheumatoid)
2. Partial amputation
3. Previous severe trauma (fracture/tendon rupture/charcots)
4. Excessive scar tissue
5. Surgical intervention
6. Severe gait disturbance
7. Peripheral vascular disease (PVD)
8. Known collagen disorders
Recruitment start date
27/01/2003
Recruitment end date
31/10/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Devon & Exeter Hospital (Wonford)
Exeter
EX2 5BW
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Royal Devon and Exeter 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