Clinical trial NCT06156969: Muscle Synergies During Gait in Children With Cerebral Palsy Undergoing Robot-assisted Gait Therapy
Official title: Muscle Synergies During Gait in Children With Cerebral Palsy Undergoing Robot-assisted Gait Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Cerebral Palsy
Robotics
Gait rehabilitation
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2023-12-05
Enrollment: 19
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Cosine Similarity of the Muscle Synergies of the Most Affected Lower Limb
timeFrame: Data collected at baseline and at completion of the 7-week intervention
Secondary outcomes:
measure: Change in Gross Motor Function Measure (GMFM) Dimension D
timeFrame: Data collected at baseline and at completion of the 7-week intervention
measure: Change in Gross Motor Function Measure (GMFM) Dimension E
timeFrame: Data collected at baseline and at completion of the 7-week intervention
measure: Percent Change in 10-Meter Walk Test
timeFrame: Data collected at baseline and at completion of the 7-week intervention
measure: Percent Change in 6-Minutes Walk Test
timeFrame: Data collected at baseline and at completion of the 7-week intervention
measure: Percent Change in Edinburgh Visual Gait Scores (EVGS)
timeFrame: Data collected at baseline and at completion of the 7-week intervention
Other outcomes:
Locations:
city: Boston
country: United States
facility: Spaulding Rehabilitation Hospital
state: Massachusetts
Study officials:
affiliation: Spaulding Rehabilitation Hospital
name: Paolo Bonato, PhD
role: PRINCIPAL_INVESTIGATOR
References: