HemiplegiaNCT02751502
Home Based Adaptive Arm Training for Children
A study testing m2 Bimanual Arm Trainer (BAT) in people with Hemiplegia, run by NYU Langone Health at 1 site in United States.
Trial summary
Twenty pediatric patients aged 5-17 years with Acquired Brain Injuries (ABI) will be randomized to receive either a bimanual-to-unimanual device home training program (10 subjects) or a conventional non-device home training program (10 subjects) for a period of 6 weeks. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Hemiplegia
- What is being tested?
- m2 Bimanual Arm Trainer (BAT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to 9 Feb 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Acquired Brain Injury at least 3 months prior to enrollment.
- Unilateral hemiparesis
- History of compliance with home exercise programs in the past.
Who cannot join
- Any social or medical problem that precludes compliance with the protocol
- Comorbid seizure disorder or other neurological disease
- Treatment with botulinum toxin or intrathecal baclofen in the 3 months preceding enrollment
- Implanted neuromodulatory or electronic device or other complicating illness
- Lack of 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: Home Based Adaptive Arm Training for Children With Hemiplegia
Twenty pediatric patients aged 5-17 years with Acquired Brain Injuries (ABI) will be randomized to receive either a bimanual-to-unimanual device home training program (10 subjects) or a conventional non-device home training program (10 subjects) for a period of 6 weeks.
The specific aims of this proposal are to:
Read more
Aim 1: Introduce home-based targeted upper limb training in children with hemiplegia from ABI (Acquired Brain Injuries) using a bimanual-to-unimanual training approach It is hypothesized that child-friendly home-based upper limb bimanual-to-unimanual training will lead to greater compliance and improved motor outcome on the Fugl Myer Scale compared to a conventional home training program.
Aim 2: Improve the understanding of the pattern of recovery of isolated joint movements in the pediatric population with hemiplegia following ABI.
It is hypothesized that individuals receiving device-based bimanual-to-unimanual training will show improvement in active range of motion across upper limb joints compared with a conventional home training program.
- Conditions
- Hemiplegia
- Being tested
- m2 Bimanual Arm Trainer (BAT)
- Keywords
- Children, Pediatrics, Arm, Upper limb, bimanual training, physical training
- Medical subject headings
- Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
m2 Bimanual Arm Trainer (BAT)Device
Patients in the device group will be asked to train specific movements repeatedly with the device for 45 minutes five days a week for 6 weeks and compliance will be monitored through training logs and remotely
| Study group | Role | What they receive |
|---|---|---|
| Bimanual-to-unimanual device home training program | Experimental | Not described Receives: Device: m2 Bimanual Arm Trainer (BAT) |
| Conventional non-device home training program | No intervention | Subjects receive 6 weeks of ongoing usual and customary care schedule of home physical and occupational therapy as usual and customary care independent of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Quality of Bimanual Hand Measured by Fugl-Meyer Scale
Measure of impairments in motor functioning and recovery in children post hemiplegia.
Measured: 6 Weeks
Change From Baseline in Timed Performance of Standardized Manual Activities Measured by Hand Assessment Test
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study startJan 2017
- Primary completion9 Feb 2021
- Study completion9 Feb 2021
Why it stopped: lack of enrollment and funding + Covid-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HemiplegiaStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Renat Sukhov, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02751502
- Sponsor's protocol ID
- 15-01326
- Status last verified
- Feb 2022
- First submitted
- 19 Apr 2016
- Last updated
- 11 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Based Adaptive Arm Training for Children With Hemiplegia
- ClinicalTrials.gov ID
- NCT02751502
- Acronym / sponsor ID
- 15-01326
- Conditions
- Hemiplegia
- Keywords
- Children, Pediatrics, Arm, Upper limb, bimanual training, physical training
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of enrollment and funding + Covid-19 pandemic
- Enrolment
- 4 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- 9 Feb 2021 (actual)
- Study completion
- 9 Feb 2021 (actual)
- First posted
- 26 Apr 2016 (estimated)
- Results
- Posted 11 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Twenty pediatric patients aged 5-17 years with Acquired Brain Injuries (ABI) will be randomized to receive either a bimanual-to-unimanual device home training program (10 subjects) or a conventional non-device home training program (10 subjects) for a period of 6 weeks.
The specific aims of this proposal are to:
Aim 1: Introduce home-based targeted upper limb training in children with hemiplegia from ABI (Acquired Brain Injuries) using a bimanual-to-unimanual training approach It is hypothesized that child-friendly home-based upper limb bimanual-to-unimanual training will lead to greater compliance and improved motor outcome on the Fugl Myer Scale compared to a conventional home training program.
Aim 2: Improve the understanding of the pattern of recovery of isolated joint movements in the pediatric population with hemiplegia following ABI.
It is hypothesized that individuals receiving device-based bimanual-to-unimanual training will show improvement in active range of motion across upper limb joints compared with a conventional home training program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bimanual-to-unimanual device home training program | Experimental | Device: m2 Bimanual Arm Trainer (BAT) |
| Conventional non-device home training program | No intervention | –Subjects receive 6 weeks of ongoing usual and customary care schedule of home physical and occupational therapy as usual and customary care independent of the study. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Acquired Brain Injury at least 3 months prior to enrollment.
- Unilateral hemiparesis
- History of compliance with home exercise programs in the past.
Key exclusion criteria (5 listed)
- Any social or medical problem that precludes compliance with the protocol
- Comorbid seizure disorder or other neurological disease
- Treatment with botulinum toxin or intrathecal baclofen in the 3 months preceding enrollment
- Implanted neuromodulatory or electronic device or other complicating illness
- Lack of capacity to consent
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 |
|---|---|---|
| m2 Bimanual Arm Trainer (BAT)Patients in the device group will be asked to train specific movements repeatedly with the device for 45 minutes five days a week for 6 weeks and compliance will be monitored through training logs and remotely | Device | Bimanual-to-unimanual device home training program |
Primary outcome
Change From Baseline in Quality of Bimanual Hand Measured by Fugl-Meyer Scale
Time frame: 6 Weeks
Measure of impairments in motor functioning and recovery in children post hemiplegia.
Change From Baseline in Timed Performance of Standardized Manual Activities Measured by Hand Assessment Test
Time frame: 6 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Hemiplegia
RecruitingObservational study
Functional Benefits of Multisite Upper Limb Surgery in Children With Unilateral Cerebral Palsy (RETRO-CHIRc)
Cerebral Palsy, Hemiplegia
Not yet recruitingObservational study
Post-Stroke Apraxia, Motor Function, Balance, and Gait
Stroke, Ideomotor Apraxia
Not yet recruitingObservational study
Ideomotor Apraxia and Robotic Gait Rehabilitation Outcomes After Stroke
Stroke, Ideomotor Apraxia
Enrolling by invitationObservational study
Evaluation of a Voice-Activated Call Light System for Clients With Limited Upper-Extremity Mobility
Spinal Cord Injury (=3 Years), Traumatic Brain Injury (TBI) Patients
Active, not recruiting
Visual and Auditory Electromyography Biofeedback Among Stroke Patients
Stroke, Hemiplegia
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.
Renat Sukhov, 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 m2 Bimanual Arm Trainer (BAT) in people with Hemiplegia, 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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 11 Feb 2022. 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?
Yes. Results are posted in the registry (first posted 11 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 From Baseline in Quality of Bimanual Hand Measured by Fugl-Meyer Scale (time frame: 6 Weeks). The study lists 2 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 11 Feb 2022.