Effect of Using a Lower Limb Robotic Device for Patients With Chronic Stroke

Study Overview
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Brief Summary
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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
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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

Official Title
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Effect of a Community-based, Bionic Leg Rehabilitation Program on Biomechanical, Cardiovascular and Performance Outcomes in Patients With Chronic Stroke

Conditions
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Gait, Hemiplegic, Quality of Life, Vascular Stiffness, Stroke

Intervention / Treatment
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* Device: Alter G Bionic Leg
* Other: Normal therapy (physiotherapy)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alter G Bionic Leg<br>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. | Device: Alter G Bionic Leg<br>* Participants are randomized to a 10 week, community-based bionic leg programme. Participants must use the leg for a minimum of 1 hour per day and continue to have active physical therapy sessions.<br>Other: Normal therapy (physiotherapy)<br>* Participants are randomized to a normal therapy (physiotherapy) only program. Participants are also advised to undertake 1 hour a day of physical activity and have active physical therapy (physiotherapy) sessions.<br>|
| Active Comparator: Normal therapy<br>Participants randomised to a group including normal therapy (physiotherapy) only. All participants have previously completed normal NHS therapy. | Other: Normal therapy (physiotherapy)<br>* Participants are randomized to a normal therapy (physiotherapy) only program. Participants are also advised to undertake 1 hour a day of physical activity and have active physical therapy (physiotherapy) sessions.<br>|
| No Intervention: Usual care<br>Have completed normal NHS therapy and no longer (> 6 months) receive active physiotherapy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Gait analysis at 10-weeks post-intervention | 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. | Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. Each gait analysis assessment will take 30 minutes | 
| Change from baseline Gait analysis at 10-weeks post-intervention | The participants will be asked to walk for 6 meters, over a pressure mat (RSscan Footscan, Ipswitch, UK), for minimum of three trials in order to obtain walking gait patterns. | Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. Each gait analysis assessment will take 30 minutes | 
| Change from baseline Gait analysis at 10-weeks post-intervention | 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). | aseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. Each gait analysis assessment will take 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed-up-and-go | 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 | Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. The timed-up-and-go assessment will take 10 minutes | 
| Ashworth scale | 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. | Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. Each assessment will take 10 minutes | 
| Body mass | Body weight and body mass index will be measured | Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. Each assessment will take 5 minutes | 
| Central and peripheral blood pressures | 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. | Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. Each assessment will take 5 minutes following 20 minutes supine rest. | 
| Arterial stiffness and blood velocity of the carotid artery | 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. | Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. Each assessment will take 5 minutes following 20 minutes supine rest. | 
| Physical fitness | A 6-minute shuttle walk test will determine total distance walked. Participants' perception of exertion will be measured at 2, 4 and 6 minutes. | Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. Each assessment will take 6 minutes. | 
| Strength | 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. | Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. Each assessment will take 15 minutes. | 
| 7-day physical activity | 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. | Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. | 
| Postural Sway | 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 | Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. Each postural sway analysis assessment will take 20 minutes | 
| Manual Muscle Test | 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). | Baseline, 10-week post-intervention, 3 month follow-up, 12 month follow-up. Each assessment will take 5 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lower-limb robotic device, Gait, Balance, Pressure, Chronic stroke, Blood pressure, Blood velocity, Aerobic fitness, Strength