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

NCT06156969 | Completed Results FDA Device

• 1 other identifier: 2015P001482
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

Cerebral Palsy; Robotics; Gait rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in Gross Motor Function Measure (GMFM) Dimension D

  Data collected at baseline and at completion of the 7-week intervention

• Change in Gross Motor Function Measure (GMFM) Dimension E

  Data collected at baseline and at completion of the 7-week intervention

• Percent Change in 10-Meter Walk Test

  Data collected at baseline and at completion of the 7-week intervention

• Percent Change in 6-Minutes Walk Test

  Data collected at baseline and at completion of the 7-week intervention

• Percent Change in Edinburgh Visual Gait Scores (EVGS)

  Data collected at baseline and at completion of the 7-week intervention

Study Arms (1)

Robot-assisted gait training

EXPERIMENTAL

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

Interventions

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.

Robot-assisted gait training

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis of spastic cerebral palsy
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead

Study Sites (1)

Spaulding Rehabilitation Hospital

Boston, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Paolo Bonato, PhD
• Organization: Spaulding Rehabilitation Hospital

PBONATO@mgh.harvard.edu

617-952-6319

Study Officials

• Paolo Bonato, PhD

  Spaulding Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Motion Analysis Laboratory

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: December 5, 2023
• Study Start: October 20, 2015
• Primary Completion: September 6, 2018
• Study Completion: September 8, 2020
• Last Updated: March 19, 2024
• Results First Posted: March 19, 2024

Record last verified: 2024-03

Locations

US (1)