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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06156969
• Other study ID #: 2015P001482
• Status: Completed
• Phase: N/A
• Start date: October 20, 2015
• Est. completion date: September 8, 2020

Study information

• Verified date: March 2024
• Source: Spaulding Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: September 8, 2020
• Est. primary completion date: September 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

Intervention

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.

Locations

Country	Name	City	State
United States	Spaulding Rehabilitation Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Spaulding Rehabilitation Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Cosine Similarity of the Muscle Synergies of the Most Affected Lower Limb	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.	Data collected at baseline and at completion of the 7-week intervention
Secondary	Change in Gross Motor Function Measure (GMFM) Dimension D	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.	Data collected at baseline and at completion of the 7-week intervention
Secondary	Change in Gross Motor Function Measure (GMFM) Dimension E	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.	Data collected at baseline and at completion of the 7-week intervention
Secondary	Percent 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
Secondary	Percent 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
Secondary	Percent 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. 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.	Data collected at baseline and at completion of the 7-week intervention