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Completed

NCT Number: NCT06156969

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

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Spaulding Rehabilitation Hospital

Boston, Massachusetts, 02129, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Robot-assisted gait training

Device

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.

Primary outcomes

  1. Change in Cosine Similarity of the Muscle Synergies of the Most Affected Lower Limb

    Time frame: 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 outcomes

  1. Change in Gross Motor Function Measure (GMFM) Dimension D

    Time frame: 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.

  2. Change in Gross Motor Function Measure (GMFM) Dimension E

    Time frame: 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.

  3. Percent Change in 10-Meter Walk Test

    Time frame: 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.

  4. Percent Change in 6-Minutes Walk Test

    Time frame: 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.

  5. Percent Change in Edinburgh Visual Gait Scores (EVGS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Spaulding Rehabilitation Hospital

Other

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2020
First posted
Dec 5, 2023
Registry last updated
Mar 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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