Randomised Crossover Study With Nested Qualitative Component Investigating the Clinical Efficacy and Acceptability of Unloading Shoes in Patients With Intermittent Claudication Due to Peripheral Arterial Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Total distance walked during 6-minute walk test
研究概览
简要总结
Some people experience a cramp-like leg pain during walking that is relieved only by rest. This is called intermittent claudication (IC) and it is a common symptom of peripheral arterial disease. Patients with IC struggle to walk, which in turn lowers their quality of life.
The intensity of IC pain experienced during walking depends on several factors, including the type of footwear worn. For example, non-supportive shoes may make the calf muscles work harder during walking, leading to earlier and more-severe symptoms of IC.
A member of the research team has developed a shoe that reduces the work done by the lower-leg muscles during walking. Preliminary data indicate that, when wearing these "unloading shoes", people with IC were able to walk further without pain as compared with when wearing a normal pair of shoes. The current project aims to provide further information on the usefulness and acceptability of these shoes.
Forty people with IC will complete a set of three walking tests on two separate occasions; once whilst wearing the unloading shoes, and once whilst wearing some normal shoes. The participants will then be given a pair of unloading or normal shoes to wear for two weeks, after which we will collect information on how acceptable the shoes were to wear via a survey of all participants and one-to-one interviews with a subset of participants.
详细描述
Study design This is a single-centre, randomised crossover study with a qualitative component. Forty patients will be recruited from York Hospital. Participants will be asked to perform walking assessments on two week days within a maximum period of two weeks. Participants will be randomly assigned to complete walking assessments whilst wearing unloading shoes on day 1, followed by walking assessments whilst wearing control shoes on day 2, or vice versa. All participants will then be given the unloading or control shoes to wear for two weeks, after which they will complete a survey about how acceptable the shoes were to wear. A sub-sample of participants will also be interviewed about the acceptability of the shoes.
Study setting Recruitment for this study will take place at York Hospital, York, United Kingdom. Study assessments will take place at York St John University.
Unloading shoe The design of the "unloading" shoe to be used in this research will be a modern style of trainer-type shoe with a cosmetically-shaped rocker sole incorporated. The rocker sole will comprise of three circular curves whose arc centres are positioned at the anatomical ankle, hip and knee respectively; assuming a vertical lower limb. This is designed to influence the line of action of the ground reaction force to pass close to the anatomical joint centres and so reduce the moments needed to be generated for ambulation by the muscles acting across those joints in the lower limb. Additionally it is designed to place the ankle into a relatively plantarflexed position where the ankle plantarflexors use less energy than for instance when placed in dorsiflexion. This is in order to unload the calf muscles by providing a simultaneous reduction in ankle range of motion in relative plantarflexion but still moving with a near-normal trajectory. This also optimises the lever arm between the Achilles tendon and the ankle joint so making propulsion, and therefore calf muscle power generation, more efficient. Participants will be provided with a pair of appropriately-sized shoes, which will be produced for this study by an established shoe manufacturer - Chaneco (www.chaneco.co.uk). To allow participants to habituate to wearing the shoes before assessment, they will be allowed to walk around in the shoes at a self-selected pace for at least 5 minutes.
Control shoe During the control condition assessments, participants will wear a pair of appropriately-sized shoes, which are similar in appearance to the unloading shoes, but do not contain the altered sole. Again, these will be provided by Chaneco, and a minimum of 5 minutes walking will be allowed for habituation.
Outcome measures Primary outcome measure
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥16 years with intermittent claudication due to peripheral arterial disease
- •Resting ankle-brachial index ≤0.9 and/or imaging evidence of peripheral arterial disease
- •Stable symptoms for at least 3 months (assessed via self-report)
- •Pain-free walking distance <250 m on 6-minute walk test
- •Ambulation that is limited primarily by calf claudication on 6-minute walk test
- •Able to provide written informed consent
- •Able to read and speak English
排除标准
- •Absolute contraindications to exercise testing as defined by the American College of Sports Medicine
- •Critical limb ischemia
- •Function is uniquely impaired, e.g. vascular amputees
- •Co-morbidities that limit walking to a greater extent than intermittent claudication (e.g. severe arthritis)
- •Ambulation limited by claudication in regions other than the calf
- •Current or previous (within 6 months) use of shoe inserts, knee or ankle braces or customised shoes prescribed by a health professional
- •Ankle/foot pathology/pain on either side
- •"High-risk" foot (e.g. significant peripheral neuropathy, foot deformity, history of foot ulceration), assessed by a vascular specialist (Registrar or Consultant) or podiatrist
研究组 & 干预措施
Unloading shoes
The unloading shoe will be a trainer-type shoe with a cosmetically-shaped rocker sole. The sole will have three circular curves whose arc centres are positioned at the anatomical ankle, hip and knee respectively; assuming a vertical lower limb. This is designed to influence the line of action of the ground reaction force to pass close to the anatomical joint centres and so reduce the moments needed to be generated for ambulation by the muscles acting across those joints in the lower limb. Additionally it is designed to place the ankle into a relatively plantarflexed position where the ankle plantarflexors use less energy than for instance when placed in dorsiflexion.
干预措施: Unloading shoes (Device)
Unloading shoes
The unloading shoe will be a trainer-type shoe with a cosmetically-shaped rocker sole. The sole will have three circular curves whose arc centres are positioned at the anatomical ankle, hip and knee respectively; assuming a vertical lower limb. This is designed to influence the line of action of the ground reaction force to pass close to the anatomical joint centres and so reduce the moments needed to be generated for ambulation by the muscles acting across those joints in the lower limb. Additionally it is designed to place the ankle into a relatively plantarflexed position where the ankle plantarflexors use less energy than for instance when placed in dorsiflexion.
干预措施: Unadapted control shoe (Device)
Unadapted control shoes
The control shoes will be similar in appearance to the unloading shoes, but they will not contain the altered sole.
干预措施: Unloading shoes (Device)
Unadapted control shoes
The control shoes will be similar in appearance to the unloading shoes, but they will not contain the altered sole.
干预措施: Unadapted control shoe (Device)
结局指标
主要结局
Total distance walked during 6-minute walk test
时间窗: Measured 40 minutes after putting on the intervention or control shoes
Following a rest period of at least 20 minutes, participants will complete a 6-minute walk test in which they will be instructed to walk as far as possible within 6 minutes. A straight 30-m course will be used and the distance walked recorded.
次要结局
- Muscle activation(Measured 60 minutes after putting on the intervention or control shoes)
- Walking speed(Measured 60 minutes after putting on the intervention or control shoes)
- Pain-free walking distance during usual-pace walking(Measured 20 minutes after putting on the intervention or control shoes)
- Step length(Measured 60 minutes after putting on the intervention or control shoes)
- Joint moments(Measured 60 minutes after putting on the intervention or control shoes)
- Step cadence(Measured 60 minutes after putting on the intervention or control shoes)