ClinicalTrials.gg
Status unknownNCT03387449Updated Jan 10, 2022

Adaptive Arm Training for Children With Hemiplegia

An interventional study of Bimanual Arm Training in Cerebral Palsy, Hemiplegia and Hemiparesis, sponsored by Blythedale Children's Hospital. Status unknown at 1 site in United States. Open to participants aged 5 Years to 17 Years. Per ClinicalTrials.gov, last updated 2022-01-10.

Sponsored by Blythedale Children's Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2022), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
5 Years to 17 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 372 studies in Cerebral Palsy with a site in United States — 77 open to participants now, 106 under way, none of them phase 3. Cerebral Palsy · United States.

Planned enrollment
164th of 296
20 · median 25
Started
2017
with 13 others
No phase
218 of 372
49 open now
Registered
164th of 372
by date

Among the 372 studies in Cerebral Palsy with a site in United States, this one is the 164th largest by planned enrollment of the 296 interventional ones that give a count, is one of 14 that started in 2017, is one of 218 with no phase, and was the 164th registered.

Cerebral Palsy

1,936 studies on the registry are indexed under Cerebral Palsy; 458 are open to participants now.

This study's planned enrollment of 20 is below the median of 34 across 1,431 interventional studies indexed under Cerebral Palsy.

Browse Cerebral Palsy studies →

Open to participants now

77 of the 372 studies in Cerebral Palsy with a site in United States are open now, in 3 countries. Each count lists the studies.

All 77 open studies →

Who these studies take

Of the 270 Cerebral Palsy studies recruiting now, 27 (10%) set no upper age limit and 235 (87%) stop at 75 or younger; 255 take children under 18; 51 take healthy volunteers.

This study: 5 Years to 17 Years · all sexes · no healthy volunteers.

The full table on the hub →
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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 372 studies in Cerebral Palsy with a site in United States, or all of them as a file.
02

Study summary

The goal of this research is to provide limb training in children with hemiplegia using a bimanual-to-unimanual training approach. Twenty pediatric patients aged 5-17 years with acquired brain injury will receive training on the bimanual-to-unimanual device for a period of 9 weeks. During the training, children use both arms to operate robotic arms to play a video game. We will assess changes in hand impairment after the training.

03

Conditions studied

  • Cerebral Palsy
  • Hemiplegia
  • Hemiparesis
  • Acquired Brain Injury
04

Who can participate

Ages eligible
5 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Hemiplegia due to brain injury at least 3 months before study enrollment.

Exclusion criteria

Exclusion Criteria:

  • Any social or medical problem that precludes compliance with the protocol.
  • Treatment with botulinum toxin or intrathecal baclofen in the 3 months preceding enrollment.
  • Implanted neuromodulatory or electronic device or other complicating illness.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Bimanual Arm Training

    Children in the study will all receive the same treatment, which includes 9 weeks of training on the bimanual arm trainer robotic device.

    Device: Bimanual Arm Training

Interventions

  • DeviceBimanual Arm Training

    Device-based bimanual-to-unimanual training will be provided with the Bimanual Arm Trainer (BAT, Mirrored Motion Works, NC). The device provides bimanual-to-unimanual training of simultaneous shoulder external rotation and elbow extension, and independent training of pronation-supination and grasp and release of each hand. Range of motion and speed are recorded during training and feedback and motivation are provided through age-appropriate gaming modules.

06

What researchers measure

Primary outcomes

  1. Change in Assisting Hand Assessment

    The Assisting Hand Assessment evaluated how effectively children use their hands to complete bimanual tasks.

    Time frame: Before intervention compared to after intervention

  2. Change in Box and Box Test

    The Box and Blocks test measures how many blocks a child can move with one hand from one box to another in one minute with the impaired hand.

    Time frame: Before intervention compared to after intervention

  3. Change in range of motion

    The robotic device measures range of motion of the shoulder.

    Time frame: Before intervention compared to after intervention

07

Study locations

1 site
  • Kathleen M Friel
    Hartsdale, New York 10530, United States
08

References and documents

Individual participant data

Plan to share: Yes — We plan to share results with our collaborator Dr. Preeti Raghaven, at New York University. Dr. Raghavan created the robot we are using, has IRB approval to use the robot, and is a consultant on this study. Personal health information will not be shared.

Supporting information: Study protocol, Statistical analysis plan

Time frame: during the study

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2017 (actual). Primary completion is estimated for Dec 2022, 61 months after the start.

Of 902 non-industry interventional studies with no phase under Cerebral Palsy, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's planned 61 months is above that.

Counting every sponsor, half of 921 studies reached it within 12 months; a quarter within 5 and three quarters within 31.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 22, 2017
First posted
Jan 2, 2018
StartActual
Nov 7, 2017
Primary completionEst.
Dec 2022
CompletionEst.
Dec 2022
Last update
Jan 10, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03387449
Lead sponsor
Blythedale Children's Hospital
Responsible party
Sponsor
First posted
Jan 2, 2018
Start date
Nov 7, 2017
Primary completion
Dec 2022 (estimated)
Completion
Dec 2022 (estimated)
Last update
Jan 10, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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