Post-stroke HemiparesisNCT02749500
Early Independent Adaptive Arm and Hand Rehab
A study testing Conventional Occupational Therapy (OT) and m2 BAT in people with Post-stroke Hemiparesis, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this study is to test the hypothesis that early independent adaptive bimanual-to-unimanual training of arm and hand movements, assisted with specially designed mechanical devices: the mirrored motion bimanual arm trainer (m2 BAT), will improve motor control and function in patients with post-stroke… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Post-stroke Hemiparesis
- What is being tested?
- Conventional Occupational Therapy (OT) and m2 BAT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2017to 19 Jan 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to follow study instructions
- Ability to likely complete all required visits
- Ability to comply with the therapy protocol as assessed by the investigator
- Must be English speaking
- Subjects must have had a unilateral stroke
Who cannot join
- 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.
- 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.
- 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, 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.
- Patients who are cognitively impaired.
- Patients who lack capacity to consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University Langone Medical Center
New York, New York, 10016
About this study
Official title: Early Independent Adaptive Arm and Hand Rehabilitation Post Stroke
The purpose of this study is to test the hypothesis that early independent adaptive bimanual-to-unimanual training of arm and hand movements, assisted with specially designed mechanical devices: the mirrored motion bimanual arm trainer (m2 BAT), will improve motor control and function in patients with post-stroke hemiparesis.
Read the detailed description
This study will randomly assign individuals admitted to the inpatient stroke rehabilitation unit to receive either conventional occupational therapy (OT) or conventional OT plus 1 hour additional bimanual-to-unimanual device-assisted therapy.
- Conditions
- Post-stroke Hemiparesis
- Being tested
- Conventional Occupational Therapy (OT), m2 BAT
- Keywords
- Motor control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Occupational Therapy (OT)Other
Standard of care occupational therapy for stroke recovery
m2 BATDevice
Conventional OT plus 1 hour additional bimanual-to-unimanual device-assisted therapy.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Occupational Therapy (OT) | Active comparator | Standard of care occupational therapy for stroke recovery Receives: Other: Conventional Occupational Therapy (OT) |
| OT + Device-assisted therapy | Experimental | Conventional OT plus 1 hour additional bimanual-to-unimanual device-assisted therapy. The m2 BAT will enable repeated movement of the affected body part without the help of a therapist, providing the opportunity to maintain range-of motion in the affected limb to limit spasticity, contracture and the ensuing deformity, a major goal of rehabilitation therapy and produces movement in the affected limb from activating the patient's own brain, rather than from being acted on by an external powered source such as a robot. Receives: Other: Conventional Occupational Therapy (OT); Device: m2 BAT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance tasks of the Fugl-Meyer Scale (FMS)
This measurement will be on a 3-point ordinal scale, ranging from 0-2 with a maximum score of 66.
Measured: 12 Weeks
Upper extremity functional ability measured with Modified Rankin Scale
Measured: 12 Weeks
Stroke-related quality of life measured with the Stroke Impact Scale
Measured: 12 Weeks
Spasticity measured using the Modified Ashworth Scale
Measured: 12 Weeks
Range of motion will be measured using video
Active/passive range of motion for shoulder flexion, extension, abduction, internal and external rotation, elbow flexion and extension, pronation and supination, wrist flexion and extension, radial and ulnar deviation will be measured for affected and unaffected arms.
Measured: 12 Weeks
Upper extremity functional ability measured using the Wolf Motor Function Test
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study start1 Jun 2017
- Primary completion19 Jan 2018
- Study completion19 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-stroke HemiparesisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Tafurt, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02749500
- Sponsor's protocol ID
- 15-01460
- Status last verified
- Mar 2019
- First submitted
- 15 Apr 2016
- Last updated
- 25 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Independent Adaptive Arm and Hand Rehabilitation Post Stroke
- ClinicalTrials.gov ID
- NCT02749500
- Acronym / sponsor ID
- 15-01460
- Conditions
- Post-stroke Hemiparesis
- Keywords
- Motor control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 19 Jan 2018 (actual)
- Study completion
- 19 Jan 2019 (actual)
- First posted
- 25 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 test the hypothesis that early independent adaptive bimanual-to-unimanual training of arm and hand movements, assisted with specially designed mechanical devices: the mirrored motion bimanual arm trainer (m2 BAT), will improve motor control and function in patients with post-stroke hemiparesis.
Detailed description
This study will randomly assign individuals admitted to the inpatient stroke rehabilitation unit to receive either conventional occupational therapy (OT) or conventional OT plus 1 hour additional bimanual-to-unimanual device-assisted therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Occupational Therapy (OT) | Active comparator | Other: Conventional Occupational Therapy (OT)Standard of care occupational therapy for stroke recovery |
| OT + Device-assisted therapy | Experimental | Other: Conventional Occupational Therapy (OT), Device: m2 BATConventional OT plus 1 hour additional bimanual-to-unimanual device-assisted therapy. The m2 BAT will enable repeated movement of the affected body part without the help of a therapist, providing the opportunity to maintain range-of motion in the affected limb to limit spasticity, contracture and the ensuing deformity, a major goal of rehabilitation therapy and produces movement in the affected limb from activating the patient's own brain, rather than from being acted on by an external powered source such as a robot. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ability to follow study instructions
- Ability to likely complete all required visits
- Ability to comply with the therapy protocol as assessed by the investigator
- Must be English speaking
- Subjects must have had a unilateral stroke
Key exclusion criteria (8 listed)
- 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.
- 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.
- 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, epilepsy, or demyelinating disease.
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 |
|---|---|---|
| Conventional Occupational Therapy (OT)Standard of care occupational therapy for stroke recovery | Other | Conventional Occupational Therapy (OT), OT + Device-assisted therapy |
| m2 BATConventional OT plus 1 hour additional bimanual-to-unimanual device-assisted therapy. | Device | OT + Device-assisted therapy |
Primary outcome
Performance tasks of the Fugl-Meyer Scale (FMS)
Time frame: 12 Weeks
This measurement will be on a 3-point ordinal scale, ranging from 0-2 with a maximum score of 66.
Upper extremity functional ability measured with Modified Rankin Scale
Time frame: 12 Weeks
Stroke-related quality of life measured with the Stroke Impact Scale
Time frame: 12 Weeks
Spasticity measured using the Modified Ashworth Scale
Time frame: 12 Weeks
Range of motion will be measured using video
Time frame: 12 Weeks
Active/passive range of motion for shoulder flexion, extension, abduction, internal and external rotation, elbow flexion and extension, pronation and supination, wrist flexion and extension, radial and ulnar deviation will be measured for affected and unaffected arms.
Upper extremity functional ability measured using the Wolf Motor Function Test
Time frame: 12 Weeks
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 25 Mar 2019.
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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.
Maria Tafurt, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Occupational Therapy (OT) and m2 BAT in people with 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 5 inclusion and 8 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 25 Mar 2019. 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?
Performance tasks of the Fugl-Meyer Scale (FMS) (time frame: 12 Weeks). The study lists 6 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 25 Mar 2019.