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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Device: Robot-Assisted Gait Training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robot-assisted gait training<br>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. | Device: Robot-Assisted Gait Training<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cosine Similarity of the Muscle Synergies of the most affected lower limb | Subjects will be asked to walk overground. Surface electromyographic (EMG) data will be collected from 16 muscles of the lower limbs. EMG data will be analyzed using a mathematical technique (referred to as non-negative matrix factorization) that allows researchers to quantify the patterns of co-activation of muscles. Cosine similarity values will be estimated to capture differences between the muscle synergies observed in study participants and normative muscle synergies. These values will be compared pre- versus post-intervention as a measure of responsiveness to the intervention. The percentage number of muscle synergies displaying an improvement in cosine similarity will be reported. | Data collected at baseline and at completion of the 7-week intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Gross Motor Function Measure (GMFM) Dimension D | The GMFM Dimension D consists of a battery of motor tasks that the rater evaluates via visual observation of the motor behavior of the study participant. Dimension D of the scale is focused on standing function. | Data collected at baseline and at completion of the 7-week intervention | 
| Change in Gross Motor Function Measure (GMFM) Dimension E | The GMFM Dimension E consists of a battery of motor tasks that the rater evaluates via visual observation of the motor behavior of the study participant. Dimension E of the scale is focused on walking function. | Data collected at baseline and at completion of the 7-week intervention | 
| Change in 10-Meter Walk Test | Study staff will use a stopwatch to measure the time needed by study participants to cover a distance of 10 meters. | Data collected at baseline and at completion of the 7-week intervention | 
| Change in 6-Minutes Walk Test | Study staff will measure the distance walked by study participants during an interval of 6 min. | Data collected at baseline and at completion of the 7-week intervention | 
| Change in Edinburgh Visual Gait Scores (EVGS) | The EVGS score is a standardized measure of gait quality derived using criteria based on visual observation of gait patterns in children with cerebral palsy. | Data collected at baseline and at completion of the 7-week intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cerebral Palsy, Robotics, Gait rehabilitation