Muscle Synergies During Gait in Children With Cerebral Palsy Undergoing Robot-assisted Gait Therapy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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:
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A test to evaluate gross motor function
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A test to assess walking speed
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A test to assess endurance
Muscle activity tests:
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A test to derive detailed measures of how well participant walk using a camera-based motion capture system.
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
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.
|
Outcome Measures
Primary Outcome Measures
- 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]
Subjects will be asked to walk overground. Surface electromyographic (EMG) data will be collected from 16 muscles of the lower limbs. EMG data will be analyzed using a mathematical technique (referred to as non-negative matrix factorization) that allows researchers to quantify the patterns of co-activation of muscles. Cosine similarity values will be estimated to capture differences between the muscle synergies observed in study participants and normative muscle synergies. These values will be compared pre- versus post-intervention as a measure of responsiveness to the intervention. The percentage number of muscle synergies displaying an improvement in cosine similarity will be reported.
Secondary Outcome Measures
- 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 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.
- 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 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.
- 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.
- 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.
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of spastic cerebral palsy
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6 to 18 years of age
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Gross Motor Function (GMFCS) Level I, II, III or IV
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Femoral length < size of robotic exoskeleton used for gait training (femur length between 210-350mm)
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Ability to communicate pain or discomfort
Exclusion Criteria:
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Recent use of Lokomat within the last 3 months
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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)
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Skin ulcers in trunk or lower limbs
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Hip, knee, ankle arthrodesis
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Spaulding Rehabilitation Hospital | Boston | Massachusetts | United States | 02129 |
Sponsors and Collaborators
- Spaulding Rehabilitation Hospital
Investigators
- Principal Investigator: Paolo Bonato, PhD, Spaulding Rehabilitation Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2015P001482