Cerebral PalsyNCT03387449
Adaptive Arm Training for Children With Hemiplegia
A study testing Bimanual Arm Training in people with Cerebral Palsy and Hemiplegia, run by Blythedale Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Cerebral Palsy, Hemiplegia, Hemiparesis
- What is being tested?
- Bimanual Arm Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2017to Dec 2022
- 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 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Hemiplegia due to brain injury at least 3 months before study enrollment.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Cerebral Palsy, Hemiplegia, Hemiparesis, Acquired Brain Injury
- Being tested
- Bimanual Arm Training
- Medical subject headings
- Cerebral Palsy, Hemiplegia, Paresis, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bimanual Arm TrainingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Bimanual Arm Training | Experimental | Children in the study will all receive the same treatment, which includes 9 weeks of training on the bimanual arm trainer robotic device. Receives: Device: Bimanual Arm Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Assisting Hand Assessment
The Assisting Hand Assessment evaluated how effectively children use their hands to complete bimanual tasks.
Measured: Before intervention compared to after intervention
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.
Measured: Before intervention compared to after intervention
Change in range of motion
The robotic device measures range of motion of the shoulder.
Measured: Before intervention compared to after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2018
- Study start7 Nov 2017
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Blythedale Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03387449
- Sponsor's protocol ID
- BAT_Friel
- Status last verified
- Jan 2022
- First submitted
- 22 Dec 2017
- Last updated
- 10 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Arm Training for Children With Hemiplegia
- ClinicalTrials.gov ID
- NCT03387449
- Acronym / sponsor ID
- BAT_Friel
- Conditions
- Cerebral Palsy, Hemiplegia, Hemiparesis, Acquired Brain Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Blythedale Children's HospitalUniversity, hospital or other
- Study start
- 7 Nov 2017 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 2 Jan 2018 (actual)
- 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bimanual Arm Training | Experimental | Device: Bimanual Arm TrainingChildren in the study will all receive the same treatment, which includes 9 weeks of training on the bimanual arm trainer robotic device. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Hemiplegia due to brain injury at least 3 months before study enrollment.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Bimanual Arm TrainingDevice-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. | Device | Bimanual Arm Training |
Primary outcome
Change in Assisting Hand Assessment
Time frame: Before intervention compared to after intervention
The Assisting Hand Assessment evaluated how effectively children use their hands to complete bimanual tasks.
Change in Box and Box Test
Time frame: Before intervention compared to after intervention
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.
Change in range of motion
Time frame: Before intervention compared to after intervention
The robotic device measures range of motion of the shoulder.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2022.
- Individual participant dataSharing planned: 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bimanual Arm Training in people with Cerebral Palsy and Hemiplegia, run by Blythedale Children's Hospital 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 10 Jan 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?
Results are not available in the source record.
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 in Assisting Hand Assessment (time frame: Before intervention compared to after intervention). The study lists 3 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 10 Jan 2022.