Stroke, AcuteRERCNCT04775693
Robotic Exoskeleton Gait Training During Acute Stroke Rehabilitation
A study testing RE (Robotic Exoskeleton) in people with Stroke, Acute, run by Kessler Foundation at 1 site in United States.
Trial summary
The objective of this RCT is to explore the clinical, functional and neurophysiological effectiveness of RE-assisted (Robotic Exoskeleton) early intervention gait therapy in stroke patients during inpatient and outpatient stroke rehabilitation as compared to traditional gait training in three groups: 1) RE; 2)… Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- RE (Robotic Exoskeleton)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2017to Dec 2022
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stroke survivors < 4 weeks from most recent stroke.
- Age: 21- 80 years
- Unilateral hemiparesis
- Medical clearance by a Kessler Institute for Rehabilitation physician.
- Be able to physically fit into the exoskeleton device.
- Be able to tolerate upright standing for 30 minutes.
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- Have joint range of motion within normal functional limits for ambulation.
- Have sufficient strength to use the hemiwalker, bilateral canes or walker while wearing the RE.
- Have stable blood pressure; no diagnosis of persistent orthostatic hypotension (blood pressure drop of more than 30 millimeters of Mercury in body weight support system).
- Patient cognitive status and ability to communicate in English must be at a level consistent with that required to participate in standard motor rehabilitation, e.g. can follow directions as determined by a Kessler Institute for Rehabilitation physician or physical therapist.
- No history of injury or pathology to the unaffected limb.
Who cannot join
- Unable to physically fit within the RE: Height below 60" or above 76" and weight above 220 lbs.
- Joint contracture or spasticity of any limb that limits normal ROM during ambulation with assistive devices.
- Any medical issue that precludes full weight bearing and ambulation (e.g. orthopedic injuries, pain, severe spasticity).
- Skin issues that would prevent wearing the device.
- Pressure sore stage 2 or higher located in an area that would negatively affect weight bearing, harness fit, or therapist assistance.
- Pre-existing condition that caused exercise intolerance.(Documented uncontrolled hypertension, coronary artery disease, cardiac arrhythmia, or congestive heart failure)
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- Hospitalization for heart attack, heart surgery or acute heart failure within 3 months of enrollment in study.
- Severe cognitive or psychiatric problems as well as incontinence might be contraindications to start training with a RE.
- History of severe cardiac disease such as myocardial infarction, congestive heart failure.
- Uncontrolled seizure disorder.
- Uncontrolled spasticity that would interfere with walking in the RENeuromuscular or neurological pathologies (e.g., Parkinson's disease, spinal cord injury, or traumatic brain injury with evidence of motor weakness and multiple sclerosis) that will interfere with neuromuscular function, ambulation, or limit the range of motion of the lower limbs
- Orthopedic pathologies or history that will interfere with ambulation or limit the range of motion of the lower limbs (e.g., knee replacement, fixed contractures, inflammation)
- Pregnant as confirmed by pregnancy test.
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this RCT is to explore the clinical, functional and neurophysiological effectiveness of RE-assisted (Robotic Exoskeleton) early intervention gait therapy in stroke patients during inpatient and outpatient stroke rehabilitation as compared to traditional gait training in three groups: 1) RE; 2) RE-Standard of Care (SOC) and 3) SOC. We will evaluate the short and long-term effects on functional mobility, clinical, neurophysiological, community participation and quality of life.
- Conditions
- Stroke, Acute
- Being tested
- RE (Robotic Exoskeleton), SOC (standard of care)
- Keywords
- hemiplegia, robotic, exoskeleton, gait
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RE (Robotic Exoskeleton)Device
Participants will continue to receive their prescribed standard of care physical therapy/gait training. They will also utilize the robotic exoskeleton twice a week during their inpatient stay and 3 times a week for 5 weeks as an outpatient (for outpatient, only if in the RE group). The Robotic Exoskeleton is a device that will be strapped to the chest and legs and worn over the shoulders like a backpack that will assist in walking. It uses sensors and participant motion to move. A licensed physical therapist will be assisting participants as they use the device.
SOC (standard of care)Other
Traditional physical therapist driven gait training.
| Study group | Role | What they receive |
|---|---|---|
| RE | Experimental | Participants use the robotic exoskeleton (RE) in addition to their standard of care gait training as both an inpatient (2 days a week RE) and an outpatient (3 days a week RE). Receives: Device: RE (Robotic Exoskeleton) |
| SOC | Active comparator | Participants receive standard of care gait training only as both an inpatient (at least 2 days a week) and an outpatient (at least 3 days a week). Receives: Other: SOC (standard of care) |
| RE/SOC | Experimental | Participants use the robotic exoskeleton (RE) in addition to their standard of care gait training as an inpatient (2 days a week RE) and standard of care only as an outpatient (at least 3 days a week). Receives: Device: RE (Robotic Exoskeleton) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Independence Measure (FIM)
a conventional assessment measure of motor function
Measured: 6 months
TUG
time up and go (TUG) test
Measured: 6 months
BBA
Berg Balance Assessment (BBA)
Measured: 6 months
ROM
range of motion (ROM)- conventional assessment performed by a physical therapist
Measured: 6 months
strength
conventional assessment performed by a physical therapist
Measured: 6 months
temporal spatial parameters
collected though motion capture camera system
Measured: 6 months
plantar loading
use of shoe insoles to gather information about foot pressure
Measured: 6 months
electromyography (EMG)
a measure of muscle activation (EMG signal) at different phases of gait cycle (swing versus double support).
Measured: 6 months
SIS
stroke impact scale (SIS). questionnaire about quality of life post-stroke
Measured: 6 months
LIFE-H
assessment of life habits (LIFE-H). questionnaire about quality of life post-stroke
Measured: 6 months
SSQoL
stroke specific quality of life scale (SSQoL). questionnaire about quality of life post-stroke
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start12 May 2017
- Primary completionDec 2021 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Kessler FoundationThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen J Nolan, PhD, Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04775693
- Sponsor's protocol ID
- R-911-16
- Acronym
- RERC
- Status last verified
- Feb 2021
- First submitted
- 3 Feb 2021
- Last updated
- 1 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Exoskeleton Gait Training During Acute Stroke Rehabilitation
- ClinicalTrials.gov ID
- NCT04775693
- Acronym / sponsor ID
- RERC / R-911-16
- Conditions
- Stroke, Acute
- Keywords
- hemiplegia, robotic, exoskeleton, gait
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- 12 May 2017 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 1 Mar 2021 (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.
The objective of this RCT is to explore the clinical, functional and neurophysiological effectiveness of RE-assisted (Robotic Exoskeleton) early intervention gait therapy in stroke patients during inpatient and outpatient stroke rehabilitation as compared to traditional gait training in three groups: 1) RE; 2) RE-Standard of Care (SOC) and 3) SOC. We will evaluate the short and long-term effects on functional mobility, clinical, neurophysiological, community participation and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RE | Experimental | Device: RE (Robotic Exoskeleton)Participants use the robotic exoskeleton (RE) in addition to their standard of care gait training as both an inpatient (2 days a week RE) and an outpatient (3 days a week RE). |
| SOC | Active comparator | Other: SOC (standard of care)Participants receive standard of care gait training only as both an inpatient (at least 2 days a week) and an outpatient (at least 3 days a week). |
| RE/SOC | Experimental | Device: RE (Robotic Exoskeleton)Participants use the robotic exoskeleton (RE) in addition to their standard of care gait training as an inpatient (2 days a week RE) and standard of care only as an outpatient (at least 3 days a week). |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Stroke survivors < 4 weeks from most recent stroke.
- Age: 21- 80 years
- Unilateral hemiparesis
- Medical clearance by a Kessler Institute for Rehabilitation physician.
- Be able to physically fit into the exoskeleton device.
Key exclusion criteria (13 listed)
- Unable to physically fit within the RE: Height below 60" or above 76" and weight above 220 lbs.
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 |
|---|---|---|
| RE (Robotic Exoskeleton)Participants will continue to receive their prescribed standard of care physical therapy/gait training. They will also utilize the robotic exoskeleton twice a week during their inpatient stay and 3 times a week for 5 weeks as an outpatient (for outpatient, only if in the RE group). The Robotic Exoskeleton is a device that will be strapped to the chest and legs and worn over the shoulders like a backpack that will assist in walking. It uses sensors and participant motion to move. A licensed physical therapist will be assisting participants as they use the device. | Device | RE, RE/SOC |
| SOC (standard of care)Traditional physical therapist driven gait training. | Other | SOC |
Primary outcome
Functional Independence Measure (FIM)
Time frame: 6 months
a conventional assessment measure of motor function
TUG
Time frame: 6 months
time up and go (TUG) test
BBA
Time frame: 6 months
Berg Balance Assessment (BBA)
ROM
Time frame: 6 months
range of motion (ROM)- conventional assessment performed by a physical therapist
strength
Time frame: 6 months
conventional assessment performed by a physical therapist
temporal spatial parameters
Time frame: 6 months
collected though motion capture camera system
plantar loading
Time frame: 6 months
use of shoe insoles to gather information about foot pressure
electromyography (EMG)
Time frame: 6 months
a measure of muscle activation (EMG signal) at different phases of gait cycle (swing versus double support).
SIS
Time frame: 6 months
stroke impact scale (SIS). questionnaire about quality of life post-stroke
LIFE-H
Time frame: 6 months
assessment of life habits (LIFE-H). questionnaire about quality of life post-stroke
SSQoL
Time frame: 6 months
stroke specific quality of life scale (SSQoL). questionnaire about quality of life post-stroke
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
- 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.
Karen J Nolan, PhD principal investigator
Kessler Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RE (Robotic Exoskeleton) in people with Stroke, Acute, run by Kessler Foundation 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 11 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 1 Mar 2021. 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.
Are results available for this study?
Results are not available in the source record.
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?
Functional Independence Measure (FIM) (time frame: 6 months). The study lists 11 primary outcomes in all. 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 1 Mar 2021.