Hemiplegia
Conditions
Keywords
Children, Pediatrics, Arm, Upper limb, bimanual training, physical training
Brief 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. 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.
Interventions
DEVICEm2 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
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Acquired Brain Injury at least 3 months prior to enrollment. * Unilateral hemiparesis * History of compliance with home exercise programs in the past.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Quality of Bimanual Hand Measured by Fugl-Meyer Scale | 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 | 6 Weeks | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Whole Population Data reported under one arm, as randomization into arms has not occurred yet. | 4 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of funding | 4 |
Baseline characteristics
| Characteristic | Whole Population | — |
|---|---|---|
| Age, Categorical <=18 years | 4 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 0 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 4 participants | — |
| Sex: Female, Male Female | 4 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 4 |
| other Total, other adverse events | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
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.
Time frame: 6 Weeks
Population: Study terminated prior to complete data collection
Primary
Change From Baseline in Timed Performance of Standardized Manual Activities Measured by Hand Assessment Test
Time frame: 6 Weeks
Population: Study terminated prior to complete data collection