NCT03195855

Foot and Ankle Mobilisation in Diabetic Peripheral Neuropathy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: University of Plymouth · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
OTHER	Manual therapy / joint mobilisations	Manual therapy is a common form of treatment employed usually by physiotherapists, in order to help increase range of motion of a specific joint region by restoring the arthrokinematic accessory gliding and rolling movement that is associated with normal joint movement. The hypothesised mechanism of action for this is that improvements of gliding and rolling will normalise osteokinematic rotation and consequently enable the normalisation of active movements. Another possible mechanism of action of mobilisations includes increasing the extensibility of the noncontractile capsular and ligamentous tissues. The effectiveness of passive accessory gliding techniques to increase joint ROM has been widely explored in the literature; with some studies revealing an increase in ankle dorsiflexion and others no change in ankle dorsiflexion. However, the subjects taking part in these studies were people without diabetes and mostly people with ankle sprains or ankle instability.

Timeline

• Start date: 2018-05-11
• Primary completion: 2019-04-04
• Completion: 2022-01-02
• First posted: 2017-06-22
• Last updated: 2022-05-24

Locations

1 site across 1 country: United Kingdom