Clinical trial NCT03195855: Foot and Ankle Mobilisation in Diabetic Peripheral Neuropathy
Official title: The Effects of Foot and Ankle Joint Mobilisation Combined With a Home Programme of Ankle Stretches on Joint Range of Motion and Forefoot Peak Plantar Pressures in People With Diabetic Peripheral Neuropathy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Peripheral Neuropathy
Limited Joint Mobility Syndrome
Ankle Joint Range of Motion
Forefoot Peak Plantar Pressure
Foot and Ankle Mobilisations
Home Exercise Programme / Stretches
Lead sponsor: University of Plymouth
Sponsor class: OTHER
First posted: 2017-06-22
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Diabetes can affect the blood supply to the nerves in the legs. When this occurs a peripheral neuropathy can occur when the nerves carrying sensory information are affected. People with diabetic peripheral neuropathy have a high risk of foot ulceration and amputation which affects function and associated with high NHS and social care costs. People with diabetes can also have reduced movement at joints caused by increased stiffness in connective tissue. Reductions in ankle and big toe movement leads to increases in the pressure over the sole on the front part of the foot (the forefoot) when walking; this is a risk factor for ulceration.

The study will to assess whether ankle and big toe joint mobilisations and home program of stretches in people with diabetic peripheral neuropathy improves joint range of motion and reduces forefoot peak pressures.

Fifty eight people with diabetic peripheral neuropathy and a moderate risk of plantar ulceration will be recruited from a local podiatry clinic. They will be randomly assigned to an intervention (29 people) or control group (29 people). We will control for between-group differences in age using a minimization process. The intervention will consist of a 6 week program of ankle and big toe joint mobilisation by a physiotherapist and home stretches. The control group will consist of usual care including podiatry interventions.

Outcome measures will be taken at baseline, post intervention and at 3 month follow up by an assessor who does not know the group allocation. Primary outcome will be ankle range while walking with secondary outcomes including big toe joint range, forefoot pressure while walking and balance.

Changes over time between the groups will be compared statistically and the relationship between ankle range of motion and peak plantar pressure will be analysed using linear regression.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of type I or II diabetes with a moderate risk of foot ulceration as defined by i. Detection in less than \<8/10 sites on the plantar aspect of the foot using a 10 g monofilament ii. Foot deformity defined and graded using a foot deformity score previously developed for people with diabetes (54) (Attached)
* Peripheral Neuropathy- This is defined according to NICE CG19 guidelines. Here, the ability to detect a 10g monofilament (Owen Mumford "neuropen", UK) at 5 sites per foot on the plantar aspect of the toes (1,3 and 5) and metatarsophalangeal joints (1 and 5) is tested. No feeling in less than 8 sites indicates increased risk of foot ulceration (55)
* Ankle joint stiffness: Static, non-weight bearing ankle dorsiflexion will be measured using goniometry (56). Ankle joint stiffness will be defined as 0 or less ankle dorsiflexion (14, 57) due to recent evidence that these patients are more likely to exhibit limited ankle dorsiflexion of \<10 degrees during gait (58).
* Hallux joint stiffness (hallux limitus): Hallux dorsiflexion will be measured using goniometry and will be defined as \<10 degrees of available dorsiflexion at the hallux during weight bearing (59, 60).
* Able to walk for 10 meters with or without using a walking aid
* Able to attend 6 sessions over a 6 week period
* Age \>18 yrs

Exclusion Criteria:

* Plantar Ulceration: People with a current ulceration will be excluded from the study.
* Rheumatoid arthritis, ankle and 1st MTP osteoarthritis or Dupuytren's contractures as determined from medical notes and participants subjective response.
* Excessive distal lower limb oedema preventing mobilisation rated visually according to criteria (63). People with \>+2 pitting oedema in whom it is not possible to palpate the joint line will also be excluded from the study.
* History of lower limb injury in the past three months, or leg fracture/surgery in last year
* Osteoporosis as determined by the medical notes
* Prolonged (\>1 yr.) history of steroid use
* Major amputation of lower limb
* Minor foot digits amputation
* Charcot arthropathy - both stages of acute (determined by the clinical signs of unilateral swelling, elevated skin temperature, erythema and joint effusion in the foot or ankle (61)) and chronic.
* Additional neurological or oncological conditions affecting the lower limb

Primary outcomes:
measure: Change in maximum ankle range of dorsiflexion in stance phase when both feet are in contact with the ground (double support phase).
timeFrame: The change of maximum dorsiflexion between immediate treatment effects (week 6) and at 3-months post intervention follow-up period (week 18).
Secondary outcomes:
measure: Change in maximum ankle dorsiflexion during swing phase of walking as measured by 3D motion analysis.
timeFrame: The following measure will be taken at across two time periods: i) immediate effects after the intervention (change between week 0-6) and ii) 3-month post intervention follow up period (change between week 0-18).
measure: Change in total ankle range of motion during the stance phase of walking as measured by 3D motion analysis
timeFrame: The following measure will be taken at across two time periods: i) immediate effects after the intervention (change between week 0-6) and ii) 3-month post intervention follow up period (change between week 0-18).
measure: Walking forefoot peak plantar pressures will be measured using an in-shoe system (F Scan UK)
timeFrame: The following measure will be taken at across two time periods: i) immediate effects after the intervention (change between week 0-6) and ii) 3-month post intervention follow up period (change between week 0-18).
measure: Change in maximum static ankle dorsiflexion range
timeFrame: The following measure will be taken at across two time periods: i) immediate effects after the intervention (change between week 0-6) and ii) 3-month post intervention follow up period (change between week 0-18).
measure: Change in maximum 1st MTP dorsiflexion range in quiet standing
timeFrame: The following measure will be taken at across two time periods: i) immediate effects after the intervention (change between week 0-6) and ii) 3-month post intervention follow up period (change between week 0-18).
measure: Walking speed -maximal walking speed over 10 m
timeFrame: The following measure will be taken at across two time periods: i) immediate effects after the intervention (change between week 0-6) and ii) 3-month post intervention follow up period (change between week 0-18).
measure: Stride length
timeFrame: The following measure will be taken at across two time periods: i) immediate effects after the intervention (change between week 0-6) and ii) 3-month post intervention follow up period (change between week 0-18).
measure: Walking ability
timeFrame: The following measure will be taken at across two time periods: i) immediate effects after the intervention (change between week 0-6) and ii) 3-month post intervention follow up period (change between week 0-18).
measure: Change in postural sway
timeFrame: The following measure will be taken at across two time periods: i) immediate effects after the intervention (change between week 0-6) and ii) 3-month post intervention follow up period (change between week 0-18).
measure: Change in functional reach test
timeFrame: The following measure will be taken at across two time periods: i) immediate effects after the intervention (change between week 0-6) and ii) 3-month post intervention follow up period (change between week 0-18).
Other outcomes:
measure: To investigate the relationship between changes in static and dynamic ankle ROM
timeFrame: The following measures will be taken at across two time periods: i) immediate effects after the intervention (change between week 0-6) and ii) 3-month post intervention follow up period (change between week 0-18
measure: To investigate the relationship between changes in ankle ROM and balance
timeFrame: The following measures will be taken at across two time periods: i) immediate effects after the intervention (change between week 0-6) and ii) 3-month post intervention follow up period (change between week 0-18)
measure: To investigate the compliance/adherence rates of the home exercise programme
timeFrame: The following measure will be taken at across two time periods: i) immediate effects after the intervention (change between week 0-6) and ii) 3-month post intervention follow up period (change between week 0-18).
Locations:
city: Plymouth
country: United Kingdom
facility: Livewell Southwest
Study officials:
affiliation: Plymouth University
name: Vasileios Lepesis
role: PRINCIPAL_INVESTIGATOR
References: