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

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ClinicalTrials.gov Identifier: NCT03104127
Recruitment Status : Active, not recruiting
First Posted : April 7, 2017
Last Update Posted : January 11, 2019
Sponsor:
Collaborators:
Hobbs Rehabilitation
AlterG
University of Gloucestershire
University of Chester
University of Southampton
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Gait, Hemiplegic Quality of Life Vascular Stiffness Stroke Device: Alter G Bionic Leg Other: Normal therapy (physiotherapy) Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Effect of a Community-based, Bionic Leg Rehabilitation Program on Biomechanical, Cardiovascular and Performance Outcomes in Patients With Chronic Stroke
Actual Study Start Date : April 24, 2017
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : May 1, 2019

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.



Primary Outcome Measures :
  1. Change from baseline Gait analysis at 10-weeks post-intervention [ Time Frame: 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.

  2. Change from baseline Gait analysis at 10-weeks post-intervention [ Time Frame: Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. Each gait analysis assessment will take 30 minutes ]
    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.

  3. Change from baseline Gait analysis at 10-weeks post-intervention [ Time Frame: 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 :
  1. Timed-up-and-go [ Time Frame: 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

  2. Ashworth scale [ Time Frame: 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.

  3. Body mass [ Time Frame: 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

  4. Central and peripheral blood pressures [ Time Frame: 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.

  5. Arterial stiffness and blood velocity of the carotid artery [ Time Frame: 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.

  6. Physical fitness [ Time Frame: 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.

  7. Strength [ Time Frame: 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.

  8. 7-day physical activity [ Time Frame: 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.

  9. Postural Sway [ Time Frame: 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

  10. Manual Muscle Test [ Time Frame: 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).


Other Outcome Measures:
  1. Dynamic gait index [ Time Frame: Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up ]
    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).

  2. Berg Balance [ Time Frame: Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up ]
    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).

  3. Balance Confidence Scale [ Time Frame: Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up ]
    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).

  4. Walking Ability Questionnaire [ Time Frame: Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up ]
    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).

  5. Functional Ambulation Classification [ Time Frame: Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up ]
    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

  6. International Physical Activity Questionnaire [ Time Frame: Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up ]
    Collects information on the time spent (number of days and average time per day) spent being physically active.

  7. Older Peoples Quality of Life Questionnaire [ Time Frame: Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up ]
    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.

  8. Trail Making [ Time Frame: Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03104127


Locations
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United Kingdom
University of Winchester
Winchester, Hampshire, United Kingdom, SO22 4NR
Sponsors and Collaborators
University of Winchester
Hobbs Rehabilitation
AlterG
University of Gloucestershire
University of Chester
University of Southampton
University of North Carolina, Chapel Hill
Investigators
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Principal Investigator: James Faulkner, PhD University of Winchester

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Responsible Party: University of Winchester
ClinicalTrials.gov Identifier: NCT03104127     History of Changes
Other Study ID Numbers: RKE_2017_001
First Posted: April 7, 2017    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by University of Winchester:
Lower-limb robotic device
Gait
Balance
Pressure
Chronic stroke
Blood pressure
Blood velocity
Aerobic fitness
Strength
Additional relevant MeSH terms:
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Stroke
Gait Disorders, Neurologic
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Signs and Symptoms