StrokeNCT02726204
Evaluation of a Wearable Exoskeleton for Functional Arm Training
A study testing Gravity Elimination Alone, Path Assistance Alone and Path Assistance and Gravity Elimination in people with Stroke and Post-Stroke Hemiparesis, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this study is to investigate how the cable-driven arm exoskeleton (CAREX) can assist task performance during 3D arm movement tasks under various experimental conditions in healthy individuals and patients with stroke. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Post-Stroke Hemiparesis
- What is being tested?
- Gravity Elimination Alone, Path Assistance Alone and Path Assistance and Gravity Elimination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2015to 5 May 2016
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Radiologically verified unilateral stroke at least 4 months previously.
- Right-handed subjects with or without right hemiparesis (as robot is built for right arm alone).
- Preserved passive range of motion at all upper limb joints.
- Spasticity <3 on the modified Ashworth Scale (MAS).
- Ability to follow study instructions and likely to complete the protocol; ability to comply with the protocol as assessed by the investigator; must be English speaking since the assessments are in English.
- No previous stroke or any other previous neurological injury.
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- Right-handed subjects without any weakness or hemiparesis (as robot is built for right arm alone).
- Preserved passive and active range of motion at all upper limb joints.
- No increase in muscle tone in response to passive range of motion. A score of zero on Ashworth Scale (MAS).
- Able to achieve full score on upper extremity Fugl-Meyer Scale (66/66)
- Ability to follow study instructions and likely to complete the protocol; ability to comply with the protocol as assessed by the investigator; must be English speaking since the assessments are in English.
Who cannot join
- History of surgery or other significant injury to either upper extremity causing mechanical limitations that preclude task performance.
- Previous neurological illness such as head trauma, prior stroke ( as we are recruiting subjects with first unilateral stroke), epilepsy, or demyelinating disease.
- Complicating medical problems such as uncontrolled hypertension, diabetes with signs of polyneuropathy, severe renal, cardiac or pulmonary disease, or evidence of other concurrent neurologic or orthopedic conditions precluding the subject from complying with the study protocol.
- Severe upper extremity spasticity suggested by an Ashworth score of >3 at any joint, or restriction of full passive range of motion.
- Evidence of alcohol, drug abuse or other relevant neuropsychiatric condition such as psychotic illness or severe depression.
- History of surgery or other significant injury to either upper extremity causing mechanical limitations that preclude task performance.
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- Previous neurological illness such as head trauma, prior stroke, epilepsy, or demyelinating disease.
- Complicating medical problems such as uncontrolled hypertension, diabetes with signs of polyneuropathy, severe renal, cardiac or pulmonary disease, or evidence of other concurrent neurologic or orthopedic conditions precluding the subject from complying with the study protocol.
- Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.
- Severe upper extremity spasticity suggested by an Ashworth score of >3 at any joint, or restriction of full passive range of motion.
- Evidence of alcohol, drug abuse or other relevant neuropsychiatric condition such as psychotic illness or severe depression.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: Evaluation of a Wearable Exoskeleton for Functional Arm Training (CAREX)
The purpose of this study is to investigate how the cable-driven arm exoskeleton (CAREX) can assist task performance during 3D arm movement tasks under various experimental conditions in healthy individuals and patients with stroke. This study is designed to test motor learning with the robotic rehabilitative device CAREX under three conditions in healthy subjects and subjects with post-stroke hemiparesis.
- Conditions
- Stroke, Post-Stroke Hemiparesis
- Being tested
- Gravity Elimination Alone, Path Assistance Alone, Path Assistance and Gravity Elimination
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gravity Elimination AloneOther
CAREX will compensate for the gravity of the subject's arm, i.e. subject can move their arm to a specific position and relax all the arm muscles, CAREX will hold the arm in that configuration
Path Assistance AloneOther
CAREX will push subject's arm to a pre-specified path. If the arm is not in the path, CAREX will generate some force that is proportional to the distance between the hand and the path. The subject will feel like having a spring connected between his hand and the path
Path Assistance and Gravity EliminationOther
| Study group | Role | What they receive |
|---|---|---|
| Healthy Subjects | Active comparator | Seven healthy patients will serve as controls based on preliminary data in healthy volunteers using CAREX with gravity elimination alone versus gravity elimination plus path assistance. Receives: Other: Gravity Elimination Alone; Other: Path Assistance Alone; Other: Path Assistance and Gravity Elimination |
| Chronic Post Stroke Right Side Hemiparesis | Active comparator | Radiologically verified unilateral stroke patients with at least 4 months previously. Receives: Other: Gravity Elimination Alone; Other: Path Assistance Alone; Other: Path Assistance and Gravity Elimination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Passive range of motion measured by goniometry
Measured: 1 Day
Active range of motion measured by goniometry
Measured: 1 Day
Upper extremity motor impairment measured by performance on the 33 tasks of the Fugl-Meyer Scale (FMS)
Measured: 1 Day
Spasticity measured by the Modified Ashworth Scale (MAS)
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2016 (estimated)
- Study start1 Jun 2015
- Primary completion5 May 2016
- Study completion5 May 2016
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.
- More trials run by NYU Langone HealthThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Preeti Raghavan, MD, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02726204
- Sponsor's protocol ID
- 15-00402
- Status last verified
- Dec 2018
- First submitted
- 17 Mar 2016
- Last updated
- 24 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Wearable Exoskeleton for Functional Arm Training (CAREX)
- ClinicalTrials.gov ID
- NCT02726204
- Acronym / sponsor ID
- 15-00402
- Conditions
- Stroke, Post-Stroke Hemiparesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 5 May 2016 (actual)
- Study completion
- 5 May 2016 (actual)
- First posted
- 1 Apr 2016 (estimated)
- 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 purpose of this study is to investigate how the cable-driven arm exoskeleton (CAREX) can assist task performance during 3D arm movement tasks under various experimental conditions in healthy individuals and patients with stroke. This study is designed to test motor learning with the robotic rehabilitative device CAREX under three conditions in healthy subjects and subjects with post-stroke hemiparesis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Subjects | Active comparator | Other: Gravity Elimination Alone, Other: Path Assistance Alone, Other: Path Assistance and Gravity EliminationSeven healthy patients will serve as controls based on preliminary data in healthy volunteers using CAREX with gravity elimination alone versus gravity elimination plus path assistance. |
| Chronic Post Stroke Right Side Hemiparesis | Active comparator | Other: Gravity Elimination Alone, Other: Path Assistance Alone, Other: Path Assistance and Gravity EliminationRadiologically verified unilateral stroke patients with at least 4 months previously. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Radiologically verified unilateral stroke at least 4 months previously.
- Right-handed subjects with or without right hemiparesis (as robot is built for right arm alone).
- Preserved passive range of motion at all upper limb joints.
- Spasticity <3 on the modified Ashworth Scale (MAS).
- Ability to follow study instructions and likely to complete the protocol; ability to comply with the protocol as assessed by the investigator; must be English speaking since the assessments are in English.
Key exclusion criteria (11 listed)
- History of surgery or other significant injury to either upper extremity causing mechanical limitations that preclude task performance.
- Previous neurological illness such as head trauma, prior stroke ( as we are recruiting subjects with first unilateral stroke), epilepsy, or demyelinating disease.
- Complicating medical problems such as uncontrolled hypertension, diabetes with signs of polyneuropathy, severe renal, cardiac or pulmonary disease, or evidence of other concurrent neurologic or orthopedic conditions precluding the subject from complying with the study protocol.
- Severe upper extremity spasticity suggested by an Ashworth score of >3 at any joint, or restriction of full passive range of motion.
- Evidence of alcohol, drug abuse or other relevant neuropsychiatric condition such as psychotic illness or severe depression.
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 |
|---|---|---|
| Gravity Elimination AloneCAREX will compensate for the gravity of the subject's arm, i.e. subject can move their arm to a specific position and relax all the arm muscles, CAREX will hold the arm in that configuration | Other | Chronic Post Stroke Right Side Hemiparesis, Healthy Subjects |
| Path Assistance AloneCAREX will push subject's arm to a pre-specified path. If the arm is not in the path, CAREX will generate some force that is proportional to the distance between the hand and the path. The subject will feel like having a spring connected between his hand and the path | Other | Chronic Post Stroke Right Side Hemiparesis, Healthy Subjects |
| Path Assistance and Gravity Elimination | Other | Chronic Post Stroke Right Side Hemiparesis, Healthy Subjects |
Primary outcome
Passive range of motion measured by goniometry
Time frame: 1 Day
Active range of motion measured by goniometry
Time frame: 1 Day
Upper extremity motor impairment measured by performance on the 33 tasks of the Fugl-Meyer Scale (FMS)
Time frame: 1 Day
Spasticity measured by the Modified Ashworth Scale (MAS)
Time frame: 1 Day
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 24 Dec 2018.
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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.
Preeti Raghavan, MD principal investigator
New York University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gravity Elimination Alone, Path Assistance Alone and Path Assistance and Gravity Elimination in people with Stroke and Post-Stroke Hemiparesis, run by NYU Langone Health 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 11 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 24 Dec 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 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?
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?
Passive range of motion measured by goniometry (time frame: 1 Day). The study lists 4 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 24 Dec 2018; AzTrials last refreshed its copy on 6 Nov 2026.