StrokeNCT03588663
Effect of Using a Bionic Leg on Physiological and Biomechanical Measures in Stroke Patients
A study testing Baseline Bionic Leg Assessment, Training and Follow-up Assessment in people with Stroke and Physical Activity, run by University of Winchester at 1 site in United Kingdom.
Trial summary
This study will assess the effect of wearing a wearable bionic leg, on the physiological cost index and biomechanical measures in patients with stroke. Patients will be tested during a range of activities (sit-to-stand, walking) with and without the Bionic Leg, and following a 30-min training program. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke, Physical Activity, Gait, Hemiplegic
- What is being tested?
- Baseline Bionic Leg Assessment, Training and Follow-up Assessment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Aug 2018to 8 Oct 2018
- 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 a diagnosis of stroke within 3 months to 5 years of study start date.
- Community patients who are medically stable and are either (1) currently receiving physical therapy from a neurophysiotherapy practice or (2) attending a community-based stroke support group and do not actively receive physical therapy.
- Individuals who are able to stand and step with an aid or assistance
- Patients who are cognitively aware to undertake rehabilitation exercises, physical therapy and activity.
- Patients whose height is 1.58-1.92m
- Patients whose weight is less than 159kg.
Who cannot join
- Unresolved deep-vein thrombosis
- Unstable cardiovascular conditions
- Open wounds
- Active drug resistant infections
- 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.
About this study
Official title: The Acute Effect of Using a Bionic Leg on Physiological Cost Index and Biomechanical Measures in Chronic Stroke Patients
This study will assess the effect of wearing a wearable bionic leg, on the physiological cost index and biomechanical measures in patients with stroke. Patients will be tested during a range of activities (sit-to-stand, walking) with and without the Bionic Leg, and following a 30-min training program.
Read the detailed description
The aim of this study is to investigate the acute effect of wearing a Bionic Leg on:
- The Physiological Cost Index (PCI) and Biomechanical measures (gait, postural sway) of stroke patients compared to when they do not wear a Bionic Leg.
- Whether after wearing a Bionic Leg for 30-minutes during a training session influences the Physiological Cost Index (PCI) and any Biomechanical measures (gait, postural sway) of stroke patients
Individuals who volunteer to participate in the present study will be asked to engage in 4 sessions in the laboratory. Firstly, participants will be asked to take part in two familiarisation sessions, which will be delivered on two separate occasions. These sessions will last one-hour each and will allow participants (stroke patients) to become accustomed to wearing and using the Bionic Leg. Sessions will consist of sit to stand, walking and stairs exercises, which will allow individuals to become familiarised with the Bionic Leg device. They will then be asked to complete 6x 10m walks to identify their self-selected walking pace. In session 3, individuals will be randomly assigned to either use the Bionic Leg, or not. Participants will initially be asked to stay seated and rested for 5 minutes so a resting heart rate can be taken. If participants are assigned to the Bionic Leg condition first, they will conduct all the following tests with the Bionic leg on, however, if not, they will perform all the tests without wearing the Bionic Leg. They will then partake in a 3-minute walk test, which will include walking at their self-selected pace (found in session 1) for 3 minutes. Following this a 15-minute rest period will be taken, and 3 x timed-up and go tests will be conducted (see outcome measures). Next, participants will be asked to take part in a balance test, and then a 6-minute walk test (see outcome measures). Following a 15-minute rest, participants will complete 10 x sit-to-stands.
During the testing session where participants are not wearing the Bionic Leg, once they have finished all of the above testing, participants will engage in further testing during this session. Following a 15-minute recovery period participants will take -part in a 30-minute training session whilst wearing the Bionic Leg. The training programme will ask participants to engage in a variety of walking, balance and stair exercises. Following this, individuals will be given a further 15-min rest period, and the original tests (PCI, TUG, postural sway, 6-min walk, sit-to-stand) which were detailed above, would be re-assessed. These tests will be undertaken whilst not wearing the Bionic Leg. It is anticipated that this session will last approximately 2 hours.
- Conditions
- Stroke, Physical Activity, Gait, Hemiplegic
- Being tested
- Baseline Bionic Leg Assessment, Baseline Control Condition Assessment, Training, Follow-up Assessment
- Keywords
- Robotics, Walking, Balance
- Medical subject headings
- Stroke, Motor Activity, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baseline Bionic Leg AssessmentDevice
The 'Bionic Leg' (BL) [Alter G, Fremont, CA, USA; approved by the Food and Drug Administration (FDA) in 2014], is an externally-wearable, battery-operated robotic device that assists patients and therapists during rehabilitation by providing adjustable and progressive functional mobility training. A patient or therapist can programme the BL to provide motor assistance during sit-to-stand exercises, over-ground walking, and stair climbing, with either more or less robotic-assistance, as desired by the therapist. As the BL increases stability and actively engages the affected leg during functional tasks, it enables patients to undertake more repetitions of specific tasks than when not wearing a BL.
Baseline Control Condition AssessmentOther
Participants will complete identical tasks as that undertaken with the Bionic Leg, but will complete the tasks without wearing the Bionic Leg.
TrainingOther
Participants will take -part in a 30-minute training session whilst wearing the Bionic Leg. The training programme will ask participants to engage in a variety of walking, balance and stair exercises. The training programme will include a 15-minute rest period after completion of the 30 minutes of exercises. This will take 45 minutes in total.
Follow-up AssessmentOther
45 minutes after the baseline assessment, immediately following the Training programme, the following tests (PCI, TUG, postural sway, 6-min walk, sit-to-stand) will be completed. These tests will be undertaken whilst not wearing the Bionic Leg. It is anticipated that this session will last approximately 2 hours.
| Study group | Role | What they receive |
|---|---|---|
| Bionic Leg | Experimental | Participants will wear the Bionic Leg during a series of different activities including a timed-up-and-go, balance tests, 6-min walk test and sit-to-stand exercises. Receives: Device: Baseline Bionic Leg Assessment |
| Control | Active comparator | Participants will complete a series of different activities including a timed-up-and-go, balance tests, 6-min walk test and sit-to-stand exercises without wearing the bionic leg (control condition). Receives: Other: Baseline Control Condition Assessment; Other: Training; Other: Follow-up Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Physiological Cost Index between baseline and follow-up
Physiological Cost Index is a measure of energy expenditure. The Physiological Cost Index is collected from a 3-min walking test. Prior to the test, participants remain seated for 5-mins so a resting heart rate can be recorded. It is anticipated the resting heart rate will be between 40 and 80 beats per minute. Lower heart rates are considered better than higher heart rates at rest. Thereafter, participants will walk for 3 minutes at a self-selected walking pace. Heart rate will be recorded throughout. It is anticipated that the heart rate at the end of 3 minutes will be between 80 and 120 beats per minute. Lower heart rates will be seen to be better than higher heart rates. Physiological Cost Index is calculated by (Heart rate during steady state exercise - heart rate at rest)/walking speed. The smaller change in heart rate between rest and the end of the 3 minute test, the better the Physiological Cost Index.
Measured: Baseline Bionic Leg Assessment; Baseline Control Condition Assessment; Follow-up Assessment (2 hours post-baseline)
Secondary outcomes (5)
Change in Timed-Up-and-Go between baseline and follow-up
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 and sit back down. Participants will complete 2 familiarization trials prior to the actual test itself. A minimum of 3 trials will be performed.
Measured: Baseline Bionic Leg Assessment; Baseline Control Condition Assessment; Follow-up Assessment (2 hours post-baseline)
Change in Postural Sway between baseline and follow-up
Postural sway parameters of maximal anterior-posterior and mediolateral sway will be calculated on the basis of the center of pressure. Time series will be acquired by means of a pressure mat mounted on top of a Kistler force platform (Kistler,Winterthur, Switzerland). 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; and eyes closed, shoes off. A minimum of 3 trials will be performed for each condition, each lasting 10 s. Participants will complete this test either or with or without the Bionic Leg
Measured: Baseline Bionic Leg Assessment; Baseline Control Condition Assessment; Follow-up Assessment (2 hours post-baseline)
Change in Gait analysis between baseline and follow-up
The participants will be asked to walk for 6 m, over a pressure mat (RSscan Footscan, Ipswitch, UK), for a minimum of 3 trials in order to obtain walking gait patterns. A BTS G-Walk (Brooklyn, NewYork) sensor will also be worn by the participants to collect additional spatiotemporal gait parameters (cadence, speed, stride/step length, stance/swing phase duration, single/double support duration, and pelvic girdle angles). Participants will complete this test either or with or without the Bionic Leg
Measured: Baseline Bionic Leg Assessment; Baseline Control Condition Assessment; Post-Training Program Assessment
Change in 6-min walk test between baseline and follow-up
Participants will walk around two cones placed 9 m apart. Participants will walk as far as possible in 6 minutes. Participants will complete this test either or with or without the Bionic Leg.
Measured: Baseline Bionic Leg Assessment; Baseline Control Condition Assessment; Follow-up Assessment (2 hours post-baseline)
Change in Sit-to-Stand between baseline and follow-up
10 x sit-to-stand exercises will be performed on a pressure mat
Measured: Baseline Bionic Leg Assessment; Baseline Control Condition Assessment; Follow-up Assessment (2 hours post-baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start10 Aug 2018
- Primary completion8 Oct 2018
- Study completion8 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Winchester
- Sponsor type
- University, hospital or other
- Collaborators
- University College Dublin
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03588663
- Sponsor's protocol ID
- Wright_BL_Acute_2018
- Status last verified
- Oct 2018
- First submitted
- 11 Jun 2018
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no intention to share individual participant data
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effect of Using a Bionic Leg on Physiological Cost Index and Biomechanical Measures in Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT03588663
- Acronym / sponsor ID
- Wright_BL_Acute_2018
- Conditions
- Stroke, Physical Activity, Gait, Hemiplegic
- Keywords
- Robotics, Walking, Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of WinchesterUniversity, hospital or other
- Collaborators
- University College Dublin
- Study start
- 10 Aug 2018 (actual)
- Primary completion
- 8 Oct 2018 (actual)
- Study completion
- 8 Oct 2018 (actual)
- First posted
- 17 Jul 2018 (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 assess the effect of wearing a wearable bionic leg, on the physiological cost index and biomechanical measures in patients with stroke. Patients will be tested during a range of activities (sit-to-stand, walking) with and without the Bionic Leg, and following a 30-min training program.
Detailed description
The aim of this study is to investigate the acute effect of wearing a Bionic Leg on:
- The Physiological Cost Index (PCI) and Biomechanical measures (gait, postural sway) of stroke patients compared to when they do not wear a Bionic Leg.
- Whether after wearing a Bionic Leg for 30-minutes during a training session influences the Physiological Cost Index (PCI) and any Biomechanical measures (gait, postural sway) of stroke patients
Individuals who volunteer to participate in the present study will be asked to engage in 4 sessions in the laboratory. Firstly, participants will be asked to take part in two familiarisation sessions, which will be delivered on two separate occasions. These sessions will last one-hour each and will allow participants (stroke patients) to become accustomed to wearing and using the Bionic Leg. Sessions will consist of sit to stand, walking and stairs exercises, which will allow individuals to become familiarised with the Bionic Leg device. They will then be asked to complete 6x 10m walks to identify their self-selected walking pace. In session 3, individuals will be randomly assigned to either use the Bionic Leg, or not. Participants will initially be asked to stay seated and rested for 5 minutes so a resting heart rate can be taken. If participants are assigned to the Bionic Leg condition first, they will conduct all the following tests with the Bionic leg on, however, if not, they will perform all the tests without wearing the Bionic Leg. They will then partake in a 3-minute walk test, which will include walking at their self-selected pace (found in session 1) for 3 minutes. Following this a 15-minute rest period will be taken, and 3 x timed-up and go tests will be conducted (see outcome measures). Next, participants will be asked to take part in a balance test, and then a 6-minute walk test (see outcome measures). Following a 15-minute rest, participants will complete 10 x sit-to-stands.
During the testing session where participants are not wearing the Bionic Leg, once they have finished all of the above testing, participants will engage in further testing during this session. Following a 15-minute recovery period participants will take -part in a 30-minute training session whilst wearing the Bionic Leg. The training programme will ask participants to engage in a variety of walking, balance and stair exercises. Following this, individuals will be given a further 15-min rest period, and the original tests (PCI, TUG, postural sway, 6-min walk, sit-to-stand) which were detailed above, would be re-assessed. These tests will be undertaken whilst not wearing the Bionic Leg. It is anticipated that this session will last approximately 2 hours.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bionic Leg | Experimental | Device: Baseline Bionic Leg AssessmentParticipants will wear the Bionic Leg during a series of different activities including a timed-up-and-go, balance tests, 6-min walk test and sit-to-stand exercises. |
| Control | Active comparator | Other: Baseline Control Condition Assessment, Other: Training, Other: Follow-up AssessmentParticipants will complete a series of different activities including a timed-up-and-go, balance tests, 6-min walk test and sit-to-stand exercises without wearing the bionic leg (control condition). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with a diagnosis of stroke within 3 months to 5 years of study start date.
- Community patients who are medically stable and are either (1) currently receiving physical therapy from a neurophysiotherapy practice or (2) attending a community-based stroke support group and do not actively receive physical therapy.
- Individuals who are able to stand and step with an aid or assistance
- Patients who are cognitively aware to undertake rehabilitation exercises, physical therapy and activity.
- Patients whose height is 1.58-1.92m
Key exclusion criteria (9 listed)
- Unresolved deep-vein thrombosis
- Unstable cardiovascular conditions
- Open wounds
- Active drug resistant infections
- 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 |
|---|---|---|
| Baseline Bionic Leg AssessmentThe 'Bionic Leg' (BL) [Alter G, Fremont, CA, USA; approved by the Food and Drug Administration (FDA) in 2014], is an externally-wearable, battery-operated robotic device that assists patients and therapists during rehabilitation by providing adjustable and progressive functional mobility training. A patient or therapist can programme the BL to provide motor assistance during sit-to-stand exercises, over-ground walking, and stair climbing, with either more or less robotic-assistance, as desired by the therapist. As the BL increases stability and actively engages the affected leg during functional tasks, it enables patients to undertake more repetitions of specific tasks than when not wearing a BL. | Device | Bionic Leg |
| Baseline Control Condition AssessmentParticipants will complete identical tasks as that undertaken with the Bionic Leg, but will complete the tasks without wearing the Bionic Leg. | Other | Control |
| TrainingParticipants will take -part in a 30-minute training session whilst wearing the Bionic Leg. The training programme will ask participants to engage in a variety of walking, balance and stair exercises. The training programme will include a 15-minute rest period after completion of the 30 minutes of exercises. This will take 45 minutes in total. | Other | Control |
| Follow-up Assessment45 minutes after the baseline assessment, immediately following the Training programme, the following tests (PCI, TUG, postural sway, 6-min walk, sit-to-stand) will be completed. These tests will be undertaken whilst not wearing the Bionic Leg. It is anticipated that this session will last approximately 2 hours. | Other | Control |
Primary outcome
Change in Physiological Cost Index between baseline and follow-up
Time frame: Baseline Bionic Leg Assessment; Baseline Control Condition Assessment; Follow-up Assessment (2 hours post-baseline)
Physiological Cost Index is a measure of energy expenditure. The Physiological Cost Index is collected from a 3-min walking test. Prior to the test, participants remain seated for 5-mins so a resting heart rate can be recorded. It is anticipated the resting heart rate will be between 40 and 80 beats per minute. Lower heart rates are considered better than higher heart rates at rest. Thereafter, participants will walk for 3 minutes at a self-selected walking pace. Heart rate will be recorded throughout. It is anticipated that the heart rate at the end of 3 minutes will be between 80 and 120 beats per minute. Lower heart rates will be seen to be better than higher heart rates. Physiological Cost Index is calculated by (Heart rate during steady state exercise - heart rate at rest)/walking speed. The smaller change in heart rate between rest and the end of the 3 minute test, the better the Physiological Cost Index.
5 secondary outcomes
Change in Timed-Up-and-Go between baseline and follow-up
Time frame: Baseline Bionic Leg Assessment; Baseline Control Condition Assessment; Follow-up Assessment (2 hours post-baseline)
Change in Postural Sway between baseline and follow-up
Time frame: Baseline Bionic Leg Assessment; Baseline Control Condition Assessment; Follow-up Assessment (2 hours post-baseline)
Change in Gait analysis between baseline and follow-up
Time frame: Baseline Bionic Leg Assessment; Baseline Control Condition Assessment; Post-Training Program Assessment
Change in 6-min walk test between baseline and follow-up
Time frame: Baseline Bionic Leg Assessment; Baseline Control Condition Assessment; Follow-up Assessment (2 hours post-baseline)
Change in Sit-to-Stand between baseline and follow-up
Time frame: Baseline Bionic Leg Assessment; Baseline Control Condition Assessment; Follow-up Assessment (2 hours post-baseline)
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 11 Oct 2018.
- Individual participant dataSharing planned: No. There is no intention to share individual participant data
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baseline Bionic Leg Assessment, Training and Follow-up Assessment in people with Stroke and Physical Activity, 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 11 Oct 2018. 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 in Physiological Cost Index between baseline and follow-up (time frame: Baseline Bionic Leg Assessment; Baseline Control Condition Assessment; Follow-up Assessment (2 hours post-baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Oct 2018.