Home Based Adaptive Arm Training for Children

• Sponsor: NYU Langone Health (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02751502
• Collaborator: (none)
• Enrollment: 4
• Location: 1
• Arms: 2
• Duration (Months): 49.3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hemiplegia	Device: m2 Bimanual Arm Trainer (BAT)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 4 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Home Based Adaptive Arm Training for Children With Hemiplegia
• Study Start Date: Jan 1, 2017
• Actual Primary Completion Date: Feb 9, 2021
• Actual Study Completion Date: Feb 9, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bimanual-to-unimanual device home training program	Device: 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
No Intervention: Conventional non-device home training program 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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. Change From Baseline in Timed Performance of Standardized Manual Activities Measured by Hand Assessment Test [6 Weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York University Langone Medical Center	New York	New York	United States	10016

Sponsors and Collaborators

• NYU Langone Health

Investigators

• Principal Investigator: Renat Sukhov, MD, NYU Langone Health

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 25, 2019

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT02751502
• Other Study ID Numbers: 15-01326
• First Posted: Apr 26, 2016
• Last Update Posted: Feb 11, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by NYU Langone Health: Children; Pediatrics; Arm; Upper limb; bimanual training; physical training
• Additional relevant MeSH terms: Hemiplegia

Study Results

Participant Flow

Arm/Group Title	Whole Population
Arm/Group Description	Data reported under one arm, as randomization into arms has not occurred yet.
Period Title: Overall Study
STARTED	4
COMPLETED	0
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	Whole Population
Arm/Group Description	Data reported under one arm, as randomization into arms has not occurred yet.
Overall Participants	4
Age (Count of Participants)
<=18 years	4 100%
Between 18 and 65 years	0 0%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	4 100%
Male	0 0%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	4 100%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Quality of Bimanual Hand Measured by Fugl-Meyer Scale
Description	Measure of impairments in motor functioning and recovery in children post hemiplegia.
Time Frame	6 Weeks

Outcome Measure Data

Analysis Population Description

Study terminated prior to complete data collection

Arm/Group Title	Whole Population
Arm/Group Description	Data reported under one arm, as randomization into arms has not occurred yet.
Measure Participants	0

2. Primary Outcome

Title	Change From Baseline in Timed Performance of Standardized Manual Activities Measured by Hand Assessment Test
Time Frame	6 Weeks

Outcome Measure Data

Analysis Population Description

Study terminated prior to complete data collection

Arm/Group Title	Whole Population
Arm/Group Description	Data reported under one arm, as randomization into arms has not occurred yet.
Measure Participants	0

Adverse Events

Time Frame	6 weeks
Adverse Event Reporting Description	Study terminated prior to complete data collection.
Arm/Group Title	Whole Population
Arm/Group Description	Data reported under one arm, as randomization into arms has not occurred yet.
All Cause Mortality
	Whole Population
	Affected / at Risk (%)	# Events
Total	0/4 (0%)
Serious Adverse Events
	Whole Population
	Affected / at Risk (%)	# Events
Total	0/4 (0%)
Other (Not Including Serious) Adverse Events
	Whole Population
	Affected / at Risk (%)	# Events
Total	0/4 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.