Clinical trial NCT06593886: Promoting Upright Mobility in Infants With Cerebral Palsy Using a Robotic Unweighting System
Official title: Promoting Upright Mobility in Infants With Cerebral Palsy Using a Robotic Unweighting System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Cerebral Palsy
Physical Therapy Modalities
Brain Injuries
Keywords: Mobility
INFANTS
Robotic Unweighting System
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2024-09-19
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: BabyG is a soft harness attached to a robotic system mounted overhead. While wearing the harness, the infant is free to move around a 10-by-10-foot play area with a padded floor. The harness helps support the infant s weight; it also slows any falls and catches the body before it hits the floor. BabyG can be adjusted to support 5% to 50% of the infant s weight.

Participants will be in the study for 24 weeks, including 12 weeks with BabyG training and 12 weeks without. Training will be 90 minutes per week: either two 45-minute sessions or three 30-minute sessions.

All participants will undergo tests during the 24 weeks such as:

A test to measure an infant s ability to perform tasks such as rolling, sitting, crawling, and walking.

A test to assess nerve function, movements, reflexes, posture, and muscle tone.

A test of brain activity while moving. The infant will be fitted with a snug cap with 64 electrodes. Then the infant will be placed in the BabyG harness and encouraged to take steps on a motorized treadmill. Their movements will be filmed.

Detailed description: Study Description:

This phase IIb randomized crossover trial will evaluate the effects of 12 weeks of mobility training while in a computer-controlled (robotic) unweighting system (BabyG) on motor development rate in infants diagnosed with or at high risk for cerebral palsy (CP) who are less than 18 months old at enrollment compared to a 12-week period when they are not participating in training.

Objectives:

* Primary 1: Evaluate the effects of mobility training with the BabyG robotic unweighting system on motor developmental rate in infants from 5 -18 months compared to an equivalent amount of time when they are not doing the training.
* Primary 2: Evaluate the effects of BabyG mobility training on EEG brain activation patterns during treadmill stepping with the least amount of support needed in infants 5 -18 months, as compared to an equivalent amount of time when they are not doing the training.
* Secondary 1: Evaluate changes in muscle size of the rectus femoris and gastrocnemius muscles as assessed by muscle ultrasound before and after training and compared across training and no-training periods.
* Secondary 2: Relate the age at which the infant starts and their compliance with the BabyG training (total training time) with their

post-training outcomes.

Endpoints:

* Primary Endpoint 1: Compare change in the Bayley IV age equivalents and the GMFM-66 during the training and no-training periods.
* Primary Endpoint 2: Changes in EEG brain activity during supported stepping on an infant treadmill as a result of training. We will quantify and compare changes in the magnitude of activation in multiple EEG frequency bands in motor-related brain regions after

training and no-training periods.

* Secondary Endpoint 1: Changes in brain activation will be correlated w/ changes in Bayley IV and GMFM-66
* Secondary Endpoint 2: The absolute and percent change in muscle size of two muscle groups as a result of training.
* Secondary Endpoint 3: The infant age in months and the total training time in minutes will be correlated with the pre-post change scores on motor, EEG and muscle outcomes

Eligibility criteria: * INCLUSION CRITERIA

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. At least 5 months (adjusted for prematurity for those 37 weeks of gestation or less and is based on their due date) and no more than 18 months of age at enrollment
2. A diagnosis of CP or high risk of CP
3. Ability to push up on extended arms in prone for at least 10 seconds or demonstrates an interest in moving from one place to another by rolling, scooting or other means
4. Availability to return to NIH CC with parent or caregiver for training and assessment sessions.

EXCLUSION CRITERIA

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Secondary orthopedic, neuromuscular or cardiovascular conditions unrelated to CP that would impede mobility such as hip dysplasia, clubfeet, uncorrected heart defect that affects exertion levels, brachial plexus palsy, among others
2. History of surgery to the upper or lower extremities in the past 6 months
3. Seizure disorder that is not controlled by medication
4. Currently taking baclofen to reduce hypertonia
5. Enrolled in another clinical trial during the study period that involves motor training or other intervention that could influence the outcomes of this study
6. Walk independently for 10 steps on a consistent basis with or without handheld assistive devices.

Primary outcomes:
measure: Change in the Bayley IV age equivalents and the GMFM-66
timeFrame: 48 months
measure: Changes in EEG brain activity
timeFrame: 48 months
Secondary outcomes:
measure: Changes in brain activation
timeFrame: 48 months
measure: The absolute and percent change in muscle size of two muscle groups as a result of training
timeFrame: 48 months
measure: Infant age in months and the total training time in minutes
timeFrame: 48 months
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Institutes of Health Clinical Center (CC)
name: Diane L Damiano, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: