Effect of Using a Lower Limb Robotic Device for Patients With Chronic Stroke
- Conditions
- Gait, HemiplegicVascular StiffnessStrokeQuality of Life
- Interventions
- Device: Alter G Bionic LegOther: Normal therapy (physiotherapy)
- Registration Number
- NCT03104127
- Lead Sponsor
- University of Winchester
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Alter G Bionic Leg Normal therapy (physiotherapy) 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. Normal therapy Normal therapy (physiotherapy) Participants randomised to a group including normal therapy (physiotherapy) only. All participants have previously completed normal NHS therapy. Alter G Bionic Leg 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.
- Primary Outcome Measures
Name Time Method Change from baseline Gait analysis at 10-weeks post-intervention 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).
- Secondary Outcome Measures
Name Time Method 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. Pulse wave analysis (PWA) will investigate central blood pressures, augmentation index and arterial stiffness following 20 minutes supine rest. Pulse wave velocity (PWV) will also be recorded between the carotid (right and left) and femoral artery.
Ashworth scale Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. Each assessment will take 10 minutes An adapted Modified Ashworth Scale will be used to assess muscle function. This will include the assessment of; Hip flexion, extension, abduction, adduction; Knee flexion, extension; Ankle dorsiflexion, plantar flexion. Each movement will be graded from 0-5.
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 A BTS G-walk system will be used to collect Timed-Up-and-Go data. From a seated position, participants will stand, walk to a cone 3 m away, walk around the cone, and walk back to the chair sit back down. Participants will complete two familiarisation trials prior to the actual test itself. A minimum of three trials will be performed
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. Following 20 minutes supine rest, local arterial stiffness of the right and left carotid arteries will be imaged 1-2 cm proximal to the bifurcation using B-mode ultrasound.Doppler ultrasonography will be used to calculate bilaterally volumetric blood flow in the carotid artery. Blood flow will be recorded using a Doppler spectral trace for 1 minute during supine rest.
Body mass Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. Each assessment will take 5 minutes Body weight and body mass index will be measured
7-day physical activity Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. An ActivPal physical activity monitor will be used for 7 days at baseline, 5 weeks into the intervention, and on completion of the 10 week intervention to assess participants daily physical activity. Measures include; time seated, time standing, ambulation, number of steps, number of sit to stands, and energy expenditure.
Postural Sway Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. Each postural sway analysis assessment will take 20 minutes Postural sway parameters will be calculated on the basis of centre of pressure. Time series will be acquired by means of a pressure mat mounted on top of a Kistler force platform (Kistler, Winterthur, Swizerland). Participants will stand on the pressure mat, unaided if possible, and trials will consist of eyes open shoes on, eyes closed shoes on, eyes open shoes off, eyes closed shoes off. A minimum of three trials will be performed for each condition, each lasting 10s
Physical fitness Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. Each assessment will take 6 minutes. A 6-minute shuttle walk test will determine total distance walked. Participants' perception of exertion will be measured at 2, 4 and 6 minutes.
Manual Muscle Test Baseline, 10-week post-intervention, 3 month follow-up, 12 month follow-up. Each assessment will take 5 minutes This will include the assessment of; Hip flexion, extension, abduction, adduction; Knee flexion, extension; Ankle dorsiflexion, plantar flexion on a 5-point scale. The function of the muscle will be graded from 0 (no contractions felt in the muscle) to 5 (holds test position against strong pressure).
Strength Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. Each assessment will take 15 minutes. Lower Limb muscle strength will be assessed using a Lafayette hand held dynamometer (Lafayette, USA). Measures will include; Hip abduction, adduction, flexion; Knee flexion, extension;. Ankle dorsiflexion, plantar flexion. Participants will be on a massage bed and perform up to three maximal trials for each measure with a minimum of one minutes rest between each measure.
Trial Locations
- Locations (1)
University of Winchester
đŸ‡¬đŸ‡§Winchester, Hampshire, United Kingdom