Effect of a Community-based, Bionic Leg Rehabilitation Program on Biomechanical, Cardiovascular and Performance Outcomes in Patients With Chronic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change from baseline Gait analysis at 10-weeks post-intervention
研究概览
简要总结
This study will investigate if a lower limb robotic device can be used in a community setting to increase the amount of physical activity that individuals undertake following stroke and consequently improve biomechanical, physiological and health outcomes, in patients with stroke.
详细描述
Recent advances in technology have helped to develop robotic devices to aid gait training in order to develop more normal movement patterns, strengthen the quadriceps and improve quality of gait. Lower limb robotic devices have been shown to increase functional mobility, walking speed, step length, balance and endurance within a clinical setting. The purpose of this study is to see if a lower limb robotic device leg can be used in a community setting to improve biomechanical (gait, balance, lower-limb strength), physiological (vascular health) and performance outcomes (aerobic fitness, strength) in patients with chronic stroke
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with diagnosis of stroke within 3-60 months
- •Community patients that are medically stable and currently receiving therapeutic input from Hobbs Rehabilitation
- •Individuals who are able to stand and step with an aid or assistance
- •Cognitively aware of task demands
- •Height: 5ft 2-6ft 3 (158-192 cm)
- •Weight: <25 stone (< 159kg)
排除标准
- •Unresolved deep vein thrombosis
- •Unstable cardiovascular conditions
- •Open wounds
- •Active drug resistant infection
- •Recent fractures of involved limb
- •Peripheral arterial disease
- •Incontinence
- •Severe osteoporosis
- •Non weight bearing
研究组 & 干预措施
Alter G Bionic Leg
Participants randomised to a group including normal therapy (physiotherapy) and the use of a Alter G robotic bionic leg. All participants have previously completed normal NHS therapy.
干预措施: Alter G Bionic Leg (Device)
Alter G Bionic Leg
Participants randomised to a group including normal therapy (physiotherapy) and the use of a Alter G robotic bionic leg. All participants have previously completed normal NHS therapy.
干预措施: Normal therapy (physiotherapy) (Other)
Normal therapy
Participants randomised to a group including normal therapy (physiotherapy) only. All participants have previously completed normal NHS therapy.
干预措施: Normal therapy (physiotherapy) (Other)
Usual care
Have completed normal NHS therapy and no longer (> 6 months) receive active physiotherapy.
结局指标
主要结局
Change from baseline Gait analysis at 10-weeks post-intervention
时间窗: aseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. Each gait analysis assessment will take 30 minutes
A BTS G-Walk (Brooklyn, New York) sensor will also be worn by the participants to collect additional spatio-temporal gait parameters(cadence, speed, stride/step length, stance/swing phase duration, single/double support duration and pelvic girdle angles).
Change from baseline Gait analysis at 10-weeks post-intervention
时间窗: Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. Each gait analysis assessment will take 30 minutes
Eight Qualisys cameras (six Oqus 3+, two Oqus 5+, Goteborg, Sweden) will be used to measure joint angles, rotations, hip obliquity, segment accelerations and velocities. Six Degrees or Fredom 6DoF 27 point marker set will be used and joint centres identified through palpation. The participants will be asked to walk for 6 meters for minimum of three trials in order to obtain walking gait patterns.
次要结局
- Central and peripheral blood pressures(Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. Each assessment will take 5 minutes following 20 minutes supine rest.)
- Body mass(Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. Each assessment will take 5 minutes)
- Ashworth scale(Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. Each assessment will take 10 minutes)
- Timed-up-and-go(Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. The timed-up-and-go assessment will take 10 minutes)
- Arterial stiffness and blood velocity of the carotid artery(Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. Each assessment will take 5 minutes following 20 minutes supine rest.)
- 7-day physical activity(Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up.)
- Postural Sway(Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. Each postural sway analysis assessment will take 20 minutes)
- Physical fitness(Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. Each assessment will take 6 minutes.)
- Manual Muscle Test(Baseline, 10-week post-intervention, 3 month follow-up, 12 month follow-up. Each assessment will take 5 minutes)
- Strength(Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. Each assessment will take 15 minutes.)