Ischemic StrokePhase 3NCT03554642
Walkbot Robotic Training for Improvement in Gait
A Phase 3 study testing Walkbot and Physical Therapy in people with Ischemic Stroke and Gait, Hemiplegic, run by Burke Medical Research Institute at 1 site in United States.
Trial summary
This clinical study will involve up to 30 ischemic stroke inpatients during their stay at Burke Rehabilitation Hospital. Participants will be randomized to receive 30 additional minutes of therapy every day, for a total of 2 weeks (14 days). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Ischemic Stroke, Gait, Hemiplegic
- What is being tested?
- Walkbot and Physical Therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Dec 2019
- Phase
- Phase 3
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cortical/subcortical ischemic stroke
- 1st time clinical stroke presentation, or prior stroke with no residual deficits affecting ambulation
- Ability to follow 2 step commands
- Fugl Meyer Sensory Score > 2
- Suitability for gait training as assessed clinically (ability to ambulate at least one step with a device/assistance)
- Height 132 cm- 200 cm; hip-knee joint length: 33 cm- 48 cm; knee joint-foot: 33 cm-48 cm
Who cannot join
- Cerebellar/brainstem stroke
- Body weight >135 kg
- Uncontrolled high blood pressure (stage 2) higher than 160 (systolic)/ 100 (diastolic)
- Cardiopulmonary system impairments affecting the ambulation test.
- Integumentary impairment: skin breakdown and bedsore around the loading area of the suspension belt
- No previous robotic intervention for ambulation training
Show all 15Show fewer
- Significant and persistent mental illness.
- A fixed contracture or deformity in lower extremity.
- Bone instability (non-consolidated fractures, unstable spinal column, severe osteoporosis necessitating treatment with bisphosphonates).
- Other neurodegenerative disorders (Amyotrophic lateral sclerosis, Parkinsonian disorder).
- Modified Ashworth scale >3 in affected leg.
- Significant back or leg pain that creates an inability to tolerate movement.
- Decreased sensation that will impair patient's ability to percept whether the device is properly fitted
- Aphasia of a degree that would prevent the patient from communicating discomfort.
- Inability to tolerate the Walkbot device or ambulation therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Burke Medical Research Institute
White Plains, New York, 10605
About this study
Official title: Walkbot Robotic Training for Improvement in Gait in Sub-Acute Stroke
This clinical study will involve up to 30 ischemic stroke inpatients during their stay at Burke Rehabilitation Hospital. Participants will be randomized to receive 30 additional minutes of therapy every day, for a total of 2 weeks (14 days). One group will receive 30 minutes of standard physical therapy focused on pre-gait or gait training activities, while the experimental group will receive 30 minutes of Walkbot with Augmented Reality. Both groups will receive the same time in therapy aimed at gait training.
Read the detailed description
This controlled clinical study will involve 30 ischemic stroke inpatients during their stay at Burke Rehabilitation Hospital (typical inpatient arrives 7 days post-stroke and is admitted for ~16 days).
Stroke inpatients will be sequentially randomized into one of two groups within the first week after admission. Both Groups will receive 30 additional minutes of therapy every day, for a total of 2 weeks (14 days). Group A will enroll 15 patients who will receive usual inpatient care including at least one 60-minute session of physical therapy per day, and an additional 30-minute session of standard physical therapy focused on pre-gait and/or gait training activities 5-days per week during the duration of their stay (14 days). Group B will enroll 15 patients who receive usual inpatient care that includes at least one 60-minute session of physical therapy and an additional 30-minute session of Walkbot with Augmented Reality 5-days per week during the duration of their stay (14 days). Both groups will receive the same time in therapy aimed at gait training. The extra therapy group will not exceed more than 15 minutes of pregait training before starting to walk the patient, and will spend at least 15 minutes doing active gait training per session. Patients in the treatment group will receive 30 minutes of total training on the Walkbot, excluding setup time. Primary and secondary outcomes will be collected, prior to the first therapy session. Follow up outcome measures will be collected within two days after the final interventional (study) therapy session. The amount of therapists needed for each session will be logged for every patient after Walkbot training or extra physical therapy. Borg rating of perceived exertion will be taken after each session from the patients, and NASA Task Load Index will be completed by the therapists (ie therapist load). Outcomes will be analyzed for significant differences.
- Conditions
- Ischemic Stroke, Gait, Hemiplegic
- Being tested
- Walkbot, Physical Therapy
- Medical subject headings
- Ischemic Stroke, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WalkbotDevice
Walkbot is a Robot Assisted Gait Training System. This system is designed to maximize muscle strength, range of joint motion, and gait function while participants engage in a virtual reality game.
Physical TherapyBehavioural
30-minute session of standard physical therapy focused on pre-gait and/or gait training activities 5-days per week during the duration of their stay (14 days).
| Study group | Role | What they receive |
|---|---|---|
| Walkbot Training | Experimental | This group will receive usual inpatient care that includes at least one 60-minute session of physical therapy and an additional 30-minute session of Walkbot with Augmented Reality 5-days per week during the duration of their stay (14 days). Receives: Device: Walkbot |
| Physical Therapy | Active comparator | This group will receive usual inpatient care including at least one 60-minute session of physical therapy per day, and an additional 30-minute session of standard physical therapy focused on pre-gait and/or gait training activities 5-days per week during the duration of their stay (14 days). Receives: Behavioral: Physical Therapy |
| Usual Care Physical Therapy | No intervention | Participants in this group will receive usual inpatient care including at least one 60-minute session of physical therapy per day. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl Meyer Assessment
Lower extremity impairment measure
Measured: Discharge evaluation (within 2 days after last session)
Secondary outcomes (9)
NIH Stroke Scale
Quantitative measure of stroke-related neurological deficit; The scale is comprised of 11 items with a maximal score of 42 and minimum of 0. Higher scores indicate severe stroke.
Measured: Baseline assessment and discharge evaluation within 2 days after last session
Modified Ashworth Scale
Measure of spasticity; Each muscle assessed is scored between 0-4, with 4 indicating rigid limbs or very severely affected.
Measured: Baseline assessment and discharge evaluation within 2 days after last session
Functional Ambulation Classification
Clinical measure of mobility
Measured: Baseline assessment and discharge evaluation within 2 days after last session
6 Minute Walk Test
Measures the distance that a patient can walk on a flat, hard surface in a period of 6 minutes.
Measured: Baseline assessment and discharge evaluation within 2 days after last session
10 Meter Walk Test
Examines gait speed
Measured: Baseline assessment and discharge evaluation within 2 days after last session
Timed Up and Go
Assesses mobility in both static and dynamic balance
Measured: Baseline assessment and discharge evaluation within 2 days after last session
Berg Balance Scale
Assesses balance during a series of 14 tasks; higher scores indicate greater independence.
Measured: Baseline assessment and discharge evaluation within 2 days after last session
Burke Lateropulsion Scale
5 item scale measures lateropulsion or "Pusher Syndrome" by assessing reaction to change in postural position; 0 = no lateropulsion, 17= maximum score.
Measured: Baseline assessment and discharge evaluation within 2 days after last session
Beck Depression Inventory
21 question, multiple choice, self-report inventory to assess depression; score of 0= minimal depression, 63= severe depression.
Measured: Baseline assessment and discharge evaluation within 2 days after last session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2018
- Study startSep 2016
- Primary completionDec 2018
- Study completionDec 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 Ischemic 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Sequential randomization into one of two groups within first week after admission.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Burke Medical Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- P&S Mechanics Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Kathleen Friel, PhD, Principal investigator, Burke Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03554642
- Sponsor's protocol ID
- BRC532
- Status last verified
- Jan 2020
- First submitted
- 15 May 2018
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No plan to share individual participant data with other researchers at this time.
Publications
Park C, Oh-Park M, Bialek A, Friel K, Edwards D, You JSH. Abnormal synergistic gait mitigation in acute stroke using an innovative ankle-knee-hip interlimb humanoid robot: a preliminary randomized controlled trial. Sci Rep. 2021 Nov 24;11(1):22823. doi: 10.1038/s41598-021-01959-z.
PubMed 34819515
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Walkbot Robotic Training for Improvement in Gait in Sub-Acute Stroke
- ClinicalTrials.gov ID
- NCT03554642
- Acronym / sponsor ID
- BRC532
- Conditions
- Ischemic Stroke, Gait, Hemiplegic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Burke Medical Research InstituteUniversity, hospital or other
- Collaborators
- P&S Mechanics Co., Ltd.
- Study start
- Sep 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 13 Jun 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 clinical study will involve up to 30 ischemic stroke inpatients during their stay at Burke Rehabilitation Hospital. Participants will be randomized to receive 30 additional minutes of therapy every day, for a total of 2 weeks (14 days). One group will receive 30 minutes of standard physical therapy focused on pre-gait or gait training activities, while the experimental group will receive 30 minutes of Walkbot with Augmented Reality. Both groups will receive the same time in therapy aimed at gait training.
Detailed description
This controlled clinical study will involve 30 ischemic stroke inpatients during their stay at Burke Rehabilitation Hospital (typical inpatient arrives 7 days post-stroke and is admitted for ~16 days).
Stroke inpatients will be sequentially randomized into one of two groups within the first week after admission. Both Groups will receive 30 additional minutes of therapy every day, for a total of 2 weeks (14 days). Group A will enroll 15 patients who will receive usual inpatient care including at least one 60-minute session of physical therapy per day, and an additional 30-minute session of standard physical therapy focused on pre-gait and/or gait training activities 5-days per week during the duration of their stay (14 days). Group B will enroll 15 patients who receive usual inpatient care that includes at least one 60-minute session of physical therapy and an additional 30-minute session of Walkbot with Augmented Reality 5-days per week during the duration of their stay (14 days). Both groups will receive the same time in therapy aimed at gait training. The extra therapy group will not exceed more than 15 minutes of pregait training before starting to walk the patient, and will spend at least 15 minutes doing active gait training per session. Patients in the treatment group will receive 30 minutes of total training on the Walkbot, excluding setup time. Primary and secondary outcomes will be collected, prior to the first therapy session. Follow up outcome measures will be collected within two days after the final interventional (study) therapy session. The amount of therapists needed for each session will be logged for every patient after Walkbot training or extra physical therapy. Borg rating of perceived exertion will be taken after each session from the patients, and NASA Task Load Index will be completed by the therapists (ie therapist load). Outcomes will be analyzed for significant differences.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Sequential randomization into one of two groups within first week after admission.
| Arm | Type | Receives |
|---|---|---|
| Walkbot Training | Experimental | Device: WalkbotThis group will receive usual inpatient care that includes at least one 60-minute session of physical therapy and an additional 30-minute session of Walkbot with Augmented Reality 5-days per week during the duration of their stay (14 days). |
| Physical Therapy | Active comparator | Behavioral: Physical TherapyThis group will receive usual inpatient care including at least one 60-minute session of physical therapy per day, and an additional 30-minute session of standard physical therapy focused on pre-gait and/or gait training activities 5-days per week during the duration of their stay (14 days). |
| Usual Care Physical Therapy | No intervention | –Participants in this group will receive usual inpatient care including at least one 60-minute session of physical therapy per day. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Cortical/subcortical ischemic stroke
- 1st time clinical stroke presentation, or prior stroke with no residual deficits affecting ambulation
- Ability to follow 2 step commands
- Fugl Meyer Sensory Score > 2
- Suitability for gait training as assessed clinically (ability to ambulate at least one step with a device/assistance)
Key exclusion criteria (15 listed)
- Cerebellar/brainstem stroke
- Body weight >135 kg
- Uncontrolled high blood pressure (stage 2) higher than 160 (systolic)/ 100 (diastolic)
- Cardiopulmonary system impairments affecting the ambulation test.
- Integumentary impairment: skin breakdown and bedsore around the loading area of the suspension belt
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 |
|---|---|---|
| WalkbotWalkbot is a Robot Assisted Gait Training System. This system is designed to maximize muscle strength, range of joint motion, and gait function while participants engage in a virtual reality game. | Device | Walkbot Training |
| Physical Therapy30-minute session of standard physical therapy focused on pre-gait and/or gait training activities 5-days per week during the duration of their stay (14 days). | Behavioural | Physical Therapy |
Primary outcome
Fugl Meyer Assessment
Time frame: Discharge evaluation (within 2 days after last session)
Lower extremity impairment measure
9 secondary outcomes
NIH Stroke Scale
Time frame: Baseline assessment and discharge evaluation within 2 days after last session
Modified Ashworth Scale
Time frame: Baseline assessment and discharge evaluation within 2 days after last session
Functional Ambulation Classification
Time frame: Baseline assessment and discharge evaluation within 2 days after last session
6 Minute Walk Test
Time frame: Baseline assessment and discharge evaluation within 2 days after last session
10 Meter Walk Test
Time frame: Baseline assessment and discharge evaluation within 2 days after last session
Timed Up and Go
Time frame: Baseline assessment and discharge evaluation within 2 days after last session
Berg Balance Scale
Time frame: Baseline assessment and discharge evaluation within 2 days after last session
Burke Lateropulsion Scale
Time frame: Baseline assessment and discharge evaluation within 2 days after last session
Beck Depression Inventory
Time frame: Baseline assessment and discharge evaluation within 2 days after last session
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 14 Jan 2020.
- Derived from this study: PubMed 34819515Park C, Oh-Park M, Bialek A, Friel K, Edwards D, You JSH. Abnormal synergistic gait mitigation in acute stroke using an innovative ankle-knee-hip interlimb humanoid robot: a preliminary randomized controlled trial. Sci Rep. 2021 Nov 24;11(1):22823. doi: 10.1038/s41598-021-01959-z.
- Individual participant dataSharing planned: No. No plan to share individual participant data with other researchers at this time.
Related trials for Ischemic Stroke
Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingPhase 3
Probucol for Symptomatic Intracranial and Extracranial Artery Stenosis
Ischemic Stroke, TIA
Recruiting
MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
Paralysis; Quadriplegic, Quadraplegia
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.
Kathleen Friel, PhD principal investigator
Burke Medical Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Walkbot and Physical Therapy in people with Ischemic Stroke and Gait, Hemiplegic, run by Burke Medical Research Institute at 1 site in United States.
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 15 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 14 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 States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Fugl Meyer Assessment (time frame: Discharge evaluation (within 2 days after last session)). 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 NCT03554642, 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 14 Jan 2020.