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lack of enrollment and funding + Covid-19 pandemic
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bimanual-to-unimanual device home training program | Experimental |
| |
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 Weeks |
| Change From Baseline in Timed Performance of Standardized Manual Activities Measured by Hand Assessment Test | 6 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Renat Sukhov, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University Langone Medical Center | New York | New York | 10016 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Whole Population | Data reported under one arm, as randomization into arms has not occurred yet. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Whole Population | Data reported under one arm, as randomization into arms has not occurred yet. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Study terminated prior to complete data collection | Posted | 6 Weeks |
|
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6 weeks
Study terminated prior to complete data collection.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Whole Population | Data reported under one arm, as randomization into arms has not occurred yet. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Renat Sukhov, MD | NYU Langone Health | 347-377-5138 | Renat.Sukhov@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 25, 2019 | Feb 10, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006429 | Hemiplegia |
| ID | Term |
|---|---|
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Primary | Change From Baseline in Timed Performance of Standardized Manual Activities Measured by Hand Assessment Test | Study terminated prior to complete data collection | Posted | 6 Weeks |
|
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| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |