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

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Quality of Life; Vascular Stiffness; Gait, Hemiplegic
• Intervention / Treatment: Device: Alter G Bionic Leg; Other: Normal therapy (physiotherapy)

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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Hampshire
    • Winchester, Hampshire, United Kingdom, SO22 4NR
      • University of Winchester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Alter G Bionic Leg; 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.; Other: Normal therapy (physiotherapy); 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.
Active Comparator: Normal therapy; Participants randomised to a group including normal therapy (physiotherapy) only. All participants have previously completed normal NHS therapy.	Other: Normal therapy (physiotherapy); 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.
No Intervention: Usual care; Have completed normal NHS therapy and no longer (> 6 months) receive active physiotherapy.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dynamic gait index	8-item test that assesses dynamic balance and gait ability. Scored by rating the participants performance; walking on a level surface, changing speed while walking, turning the head from side to side and up and down while walking, sudden turns, obstacle negotiation, and stair negotiation. The dynamic gate index has excellent reliability (ICC > 0.94; Lin et al., 2010) and validity (r = 0.83; Jonsdottir & Cattaneo, 2007).	Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up
Berg Balance	14-item test that assesses static and dynamic balance ability and fall risk in adult populations. Each activity is scored from 0-4, determined by the ability to perform the assessed activity with an overall maximum score of 56. The Berg Balance scale has excellent reliability (ICC > 0.95) and strong correlations with the Fugl-Meyer and Postural Assessment Scale for Stroke patients (r > 0.90).	Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up
Balance Confidence Scale	16-item self-report measure in which patients rate their balance confidence when performing various ambulatory activities. Rated from 0-100. This scale has excellent test-retest reliability (ICC = 0.85) within the Stroke population and adequate correlations with the Functional Gait Assessment (r = 0.53) in community dwelling elderly (Winsley & Kumar, 2010).	Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up
Walking Ability Questionnaire	19-item questionnaire to assess the participant's social limitations resulting from decreased walking ability. Mobility is classified as independent, supervised, assisted, wheelchair or unable for 19 ambulatory activities commonly performed in the home (8) and community (11).	Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up
Functional Ambulation Classification	Assesses functional ambulation in participants undergoing physical therapy. Ranges from non-functional walking to independent walking outside with a scale for 0-5 respectively. The Functional Ambulation Classification has excellent validity with the 6 minute walking test in acute Stroke patients	Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up
International Physical Activity Questionnaire	Collects information on the time spent (number of days and average time per day) spent being physically active.	Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up
Older Peoples Quality of Life Questionnaire	36-item questionnaire that assesses quality of life. Each question is rated from 0-5 from very bad to very good respectively. Previously this has shown to have excellent test-retest reliability (ICC = 0.92) and has features that made it a more suitable outcome measure of QOL in older people compared with the frequently used measure, the SF-12. 36-item questionnaire that assesses quality of life. Each question is rated from 0-5 from very bad to very good respectively. Previously this has shown to have excellent test-retest reliability (ICC = 0.92) and has features that made it a more suitable outcome measure of QOL in older people compared with the frequently used measure, the SF-12. 36-item questionnaire that assesses quality of life. Each question is rated from 0-5 from very bad to very good respectively.	Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up
Trail Making	A neuropsychological test of visual attention and task switching. Consists of two tests, including: i) a test in which the participant is instructed to connect 25 numerical dots in order, and ii) a test in which the participant is instructed to connect 25 numerical and alphabetical dots in order.	Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up

Collaborators and Investigators

• Sponsor: University of Winchester
• Collaborators: University of Southampton; University of North Carolina, Chapel Hill; AlterG; University of Gloucestershire; University of Chester; Hobbs Rehabilitation

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2017
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: March 2, 2017
• First Submitted That Met QC Criteria: March 31, 2017
• First Posted (Actual): April 7, 2017

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 16, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Balance; Gait; Blood pressure; Strength; Chronic stroke; Lower-limb robotic device; Pressure; Blood velocity; Aerobic fitness
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Stroke; Gait Disorders, Neurologic
• Other Study ID Numbers: RKE_2017_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes