NCT06156969

Muscle Synergies During Gait in Children With Cerebral Palsy Undergoing Robot-assisted Gait Therapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Spaulding Rehabilitation Hospital · Academic / Other
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cerebral Palsy

Interventions

Type	Name	Description
DEVICE	Robot-Assisted Gait Training	Training will be performed using the LokomatPro. The Lokomat consists of a driven (motorized) gait orthosis (DGO) and an advanced body weight support system, combined with a treadmill. It uses computer-controlled motors which are integrated in the gait orthosis at each hip and knee joint. The exoskeleton is secured to a person's lower limbs using straps. Training protocol: Each training session will include 30 minutes of gait training. Training will take over a period of about 6-7 weeks. Sessions will last approximately 60 minutes.

Timeline

• Start date: 2015-10-20
• Primary completion: 2018-09-06
• Completion: 2020-09-08
• First posted: 2023-12-05
• Last updated: 2024-03-19
• Results posted: 2024-03-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study