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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Change in maximum ankle range of dorsiflexion in stance phase when both feet are in contact with the ground (double support phase).
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in maximum ankle range of dorsiflexion in stance phase when both feet are in contact with the ground (double support phase).
时间窗: The change of maximum dorsiflexion between immediate treatment effects (week 6) and at 3-months post intervention follow-up period (week 18).
次要结局
- Change in maximum ankle dorsiflexion during swing phase of walking as measured by 3D motion analysis.(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).)
- Walking forefoot peak plantar pressures will be measured using an in-shoe system (F Scan UK)(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).)
- Change in total ankle range of motion during the stance phase of walking as measured by 3D motion analysis(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).)
- Walking speed -maximal walking speed over 10 m(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).)
- Stride length(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).)
- Change in postural sway(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).)
- Change in functional reach test(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).)
- Change in maximum static ankle dorsiflexion range(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).)
- Change in maximum 1st MTP dorsiflexion range in quiet standing(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).)
- Walking ability(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).)
研究者
Mr Vasileios Lepesis
Podiatry Lecturer and part-time PhD student
University of Plymouth