Gait, HemiplegicNCT03104127
Effect of Using a Lower Limb Robotic Device for Patients With Chronic Stroke
A study testing Alter G Bionic Leg and Normal therapy (physiotherapy) in people with Gait, Hemiplegic and Quality of Life, run by University of Winchester at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gait, Hemiplegic, Quality of Life, Vascular Stiffness
- What is being tested?
- Alter G Bionic Leg and Normal therapy (physiotherapy)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Apr 2017to 1 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Unresolved deep vein thrombosis
- Unstable cardiovascular conditions
- Open wounds
- Active drug resistant infection
- Recent fractures of involved limb
- Peripheral arterial disease
Show all 9Show fewer
- Incontinence
- Severe osteoporosis
- Non weight bearing
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Winchester
Winchester, Hampshire, SO22 4NR
About this study
Official title: 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.
Read the 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
- Conditions
- Gait, Hemiplegic, Quality of Life, Vascular Stiffness, Stroke
- Being tested
- Alter G Bionic Leg, Normal therapy (physiotherapy)
- Keywords
- Lower-limb robotic device, Gait, Balance, Pressure, Chronic stroke, Blood pressure, Blood velocity, Aerobic fitness, Strength
- Medical subject headings
- Gait Disorders, Neurologic, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alter G Bionic LegDevice
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.
Normal therapy (physiotherapy)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Alter G Bionic Leg | Experimental | 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. Receives: Device: Alter G Bionic Leg; Other: Normal therapy (physiotherapy) |
| Normal therapy | Active comparator | Participants randomised to a group including normal therapy (physiotherapy) only. All participants have previously completed normal NHS therapy. Receives: Other: Normal therapy (physiotherapy) |
| Usual care | No intervention | Have completed normal NHS therapy and no longer (> 6 months) receive active physiotherapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: aseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. Each gait analysis assessment will take 30 minutes
Secondary outcomes (10)
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
Measured: 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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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).
Measured: Baseline, 10-week post-intervention, 3 month follow-up, 12 month follow-up. Each assessment will take 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study start24 Apr 2017
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gait, HemiplegicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Winchester
- Sponsor type
- University, hospital or other
- Collaborators
- Hobbs Rehabilitation, AlterG, University of Gloucestershire, University of Chester, University of Southampton, University of North Carolina, Chapel Hill
- Responsible party
- Sponsor
- Investigators
- James Faulkner, PhD, Principal investigator, University of Winchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03104127
- Sponsor's protocol ID
- RKE_2017_001
- Status last verified
- Jan 2020
- First submitted
- 2 Mar 2017
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Faulkner J, Wright A, Stone K, Fryer S, Martinelli L, Lambrick D, Paine E, Stoner L. Effect of home-based, overground robotic-assisted gait training on vascular health in people with chronic stroke. Front Neurol. 2023 Mar 10;14:1093008. doi: 10.3389/fneur.2023.1093008. eCollection 2023.
PubMed 36970545
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Community-based, Bionic Leg Rehabilitation Program on Biomechanical, Cardiovascular and Performance Outcomes in Patients With Chronic Stroke
- ClinicalTrials.gov ID
- NCT03104127
- Acronym / sponsor ID
- RKE_2017_001
- Conditions
- Gait, Hemiplegic, Quality of Life, Vascular Stiffness, Stroke
- Keywords
- Lower-limb robotic device, Gait, Balance, Pressure, Chronic stroke, Blood pressure, Blood velocity, Aerobic fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of WinchesterUniversity, hospital or other
- Collaborators
- Hobbs Rehabilitation, AlterG, University of Gloucestershire, University of Chester, University of Southampton, University of North Carolina, Chapel Hill
- Study start
- 24 Apr 2017 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 7 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alter G Bionic Leg | Experimental | Device: Alter G Bionic Leg, Other: 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 | Active comparator | Other: Normal therapy (physiotherapy)Participants randomised to a group including normal therapy (physiotherapy) only. All participants have previously completed normal NHS therapy. |
| Usual care | No intervention | –Have completed normal NHS therapy and no longer (> 6 months) receive active physiotherapy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (9 listed)
- Unresolved deep vein thrombosis
- Unstable cardiovascular conditions
- Open wounds
- Active drug resistant infection
- Recent fractures of involved limb
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alter G Bionic LegParticipants 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. | Device | Alter G Bionic Leg |
| 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. | Other | Alter G Bionic Leg, Normal therapy |
Primary outcome
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.
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.
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).
10 secondary outcomes
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
Ashworth scale
Time frame: Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. Each assessment will take 10 minutes
Body mass
Time frame: Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. Each assessment will take 5 minutes
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.
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.
Physical fitness
Time frame: Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. Each assessment will take 6 minutes.
Strength
Time frame: Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up. Each assessment will take 15 minutes.
7-day physical activity
Time frame: Baseline, 10-week post-intervention, 3-month follow-up, 12 month follow-up.
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
Manual Muscle Test
Time frame: Baseline, 10-week post-intervention, 3 month follow-up, 12 month follow-up. Each assessment will take 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Derived from this study: PubMed 36970545Faulkner J, Wright A, Stone K, Fryer S, Martinelli L, Lambrick D, Paine E, Stoner L. Effect of home-based, overground robotic-assisted gait training on vascular health in people with chronic stroke. Front Neurol. 2023 Mar 10;14:1093008. doi: 10.3389/fneur.2023.1093008. eCollection 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Faulkner, PhD principal investigator
University of Winchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alter G Bionic Leg and Normal therapy (physiotherapy) in people with Gait, Hemiplegic and Quality of Life, run by University of Winchester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03104127, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.