Ignite Creation Date:
2025-12-24 @ 11:05 PM
Ignite Modification Date:
2025-12-25 @ 8:36 PM
Study NCT ID:
NCT06156969
Status:
COMPLETED
Last Update Posted:
2024-03-19
First Post:
2023-11-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Muscle Synergies During Gait in Children With Cerebral Palsy Undergoing Robot-assisted Gait Therapy
Sponsor:
Spaulding Rehabilitation Hospital
Organization:
Study Overview
Official Title:
Muscle Synergies During Gait in Children With Cerebral Palsy Undergoing Robot-assisted Gait Therapy
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single-arm longitudinal study for children with cerebral palsy with gait impairments that involves robot-assisted gait training (RGT) and includes pre and post-data collection visits. The study aims to evaluate changes in muscle synergies in children with Cerebral Palsy (CP) in response to RGT. Additionally, the study aims to investigate the relationship between muscle synergies and the clinical outcomes of RGT.
Detailed Description:
Participants will be assessed 2 times - before and after training with the robot. All the testing and training sessions will be carried out at Spaulding Rehabilitation Hospital and will include:
Clinical tests:
* A test to evaluate gross motor function
* A test to assess walking speed
* A test to assess endurance
Muscle activity tests:
* A test to derive detailed measures of how well participant walk using a camera-based motion capture system.
* Special sensors (called electromyographic - EMG - sensors) will be used to determine when and how muscles are recruited to generate movements.
Training with the Robot:
Study participants will undergo 18 sessions of robot-assisted gait training for 18 time The training sessions will be carried out by trained study staff. The robot will assist study participants to walk. Each training session will last about 1 hour.
Clinical tests:
* A test to evaluate gross motor function
* A test to assess walking speed
* A test to assess endurance
Muscle activity tests:
* A test to derive detailed measures of how well participant walk using a camera-based motion capture system.
* Special sensors (called electromyographic - EMG - sensors) will be used to determine when and how muscles are recruited to generate movements.
Training with the Robot:
Study participants will undergo 18 sessions of robot-assisted gait training for 18 time The training sessions will be carried out by trained study staff. The robot will assist study participants to walk. Each training session will last about 1 hour.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: