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

Not Applicable

Completed

Conditions: Cerebral Palsy

Interventions: Device: Robot-Assisted Gait Training

Registration Number: NCT06156969

Lead Sponsor: Spaulding Rehabilitation Hospital

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 19

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Robot-assisted gait training	Robot-Assisted Gait Training	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.

Primary Outcome Measures

Name	Time	Method
Change in Cosine Similarity of the Muscle Synergies of the Most Affected Lower Limb	Data collected at baseline and at completion of the 7-week intervention	Surface electromyographic (EMG) data collected from 16 muscles of the lower limbs during overground gait will be analyzed using the non-negative matrix factorization technique to quantify the patterns of co-activation of muscles. Cosine similarity values will be estimated for the EMG recordings collected pre- and post-intervention. Cosine similarity values will range between 0 and 1, where 1 means that the patterns of co-activation are identical to normative whereas 0 means that they are completely different (as they do not overlap). The percentage of muscle synergies displaying an increase in cosine similarity will be reported.

Secondary Outcome Measures

Name	Time	Method
Change in Gross Motor Function Measure (GMFM) Dimension D	Data collected at baseline and at completion of the 7-week intervention	The GMFM Dimension D consists of a battery of thirteen 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. Each item is scored on a 4-point ordinal scale from 0 to 3, where 0 indicates that the participant does not initiate the task; 1 indicates that the participant initiates the task; 2 indicates that the participant partially completes the task; and 3 indicates that the participant completes the task. The minimum value is 0, and the maximum value is 39. Higher values represent better function. The change from baseline to post-intervention is calculated by taking the difference between the value gathered post-intervention and the value gathered pre-intervention.
Percent Change in 6-Minutes Walk Test	Data collected at baseline and at completion of the 7-week intervention	Study staff will measure the distance walked by study participants during an interval of 6 min.
Percent Change in Edinburgh Visual Gait Scores (EVGS)	Data collected at baseline and at completion of the 7-week intervention	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. The EVGS includes 17 gait parameters and uses a three-point ordinal scale for each parameter, corresponding to normal, moderate, and severe deviation, respectively. The total score range is from 0 to 34 points, where 0 corresponds to normal gait and greater than 0 indicates gait abnormality.
Change in Gross Motor Function Measure (GMFM) Dimension E	Data collected at baseline and at completion of the 7-week intervention	The GMFM Dimension E consists of a battery of twenty-four 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. Each item is scored on a 4-point ordinal scale from 0 to 3, where 0 indicates that the participant does not initiate the task; 1 indicates that the participant initiates the task; 2 indicates that the participant partially completes the task; and 3 indicates that the participant completes the task. The minimum value is 0, and the maximum value is 72. Higher values represent a better function. The change from baseline to post-intervention is calculated by taking the difference between the value gathered post-intervention and the value gathered pre-intervention.
Percent Change in 10-Meter Walk Test	Data collected at baseline and at completion of the 7-week intervention	Study staff will use a stopwatch to measure the time needed by study participants to cover a distance of 10 meters.