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

Mass General Brigham

Status: Completed

Conditions: Cerebral Palsy

Treatments: Device: Robot-Assisted Gait Training

Study type: Interventional

Funder types: Other

Identifiers

NCT06156969

2015P001482

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of spastic cerebral palsy
• 6 to 18 years of age
• Gross Motor Function (GMFCS) Level I, II, III or IV
• Femoral length < size of robotic exoskeleton used for gait training (femur length between 210-350mm)
• Ability to communicate pain or discomfort

Exclusion criteria

• Recent use of Lokomat within the last 3 months
• Contraindication to robotic-assisted gait training such us thromboembolic disease, progressive neurologic disorder, cardiovascular or pulmonary contraindications, aggressive behaviors, severe cognitive deficits, bone instabilities, fractures, osteoporosis)
• Skin ulcers in trunk or lower limbs
• Hip, knee, ankle arthrodesis

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

Robot-assisted gait training

Experimental group

Description:

Robot-Assisted Gait Training using the LokomatPro device. Total of 18 training sessions, over a period of approximately 6-7 weeks. Sessions will last approximately 60 minutes.

Treatment:

Device: Robot-Assisted Gait Training