Cerebral Palsy
Conditions
Keywords
Cerebral Palsy, Robotics, Gait rehabilitation
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.
Interventions
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.
Sponsors
Spaulding Rehabilitation Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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 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. |
| Percent 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. |
| Percent 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. |
| Percent 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. 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 13 |
| Total | 13 |
Baseline characteristics
| Characteristic | Robot-assisted Gait Training |
|---|---|
| Age, Continuous | 13.1 years STANDARD_DEVIATION 3.4 |
| Gross Motor Function Classification System (GMFCS) Level I | 2 Participants |
| Gross Motor Function Classification System (GMFCS) Level II | 5 Participants |
| Gross Motor Function Classification System (GMFCS) Level III | 5 Participants |
| Gross Motor Function Classification System (GMFCS) Level IV | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 13 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 13 |
| other Total, other adverse events | 0 / 13 |
| serious Total, serious adverse events | 0 / 13 |
Outcome results
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.
Time frame: Data collected at baseline and at completion of the 7-week intervention
Population: Changes in the similarity of muscle synergies recorded from children with CP pre vs post-intervention using normative muscle synergies as a reference
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Robot-assisted Gait Training | Change in Cosine Similarity of the Muscle Synergies of the Most Affected Lower Limb | 2 percentage of muscle synergies | Standard Deviation 6 |
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.
Time frame: Data collected at baseline and at completion of the 7-week intervention
Population: Changes in the Gross Motor Function Measure (GMFM) Dimension D score pre- vs post-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Robot-assisted Gait Training | Change in Gross Motor Function Measure (GMFM) Dimension D | 5.9 units on a scale | Standard Deviation 8.1 |
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.
Time frame: Data collected at baseline and at completion of the 7-week intervention
Population: Changes in Gross Motor Function Measure (GMFM) Dimension E pre- vs post-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Robot-assisted Gait Training | Change in Gross Motor Function Measure (GMFM) Dimension E | 10.0 units on a scale | Standard Deviation 9.3 |
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.
Time frame: Data collected at baseline and at completion of the 7-week intervention
Population: Changes in walking speed relative to baseline (i.e., pre-training)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Robot-assisted Gait Training | Percent Change in 10-Meter Walk Test | -0.8 percentage of baseline value | Standard Deviation 28 |
Secondary
Percent Change in 6-Minutes Walk Test
Study staff will measure the distance walked by study participants during an interval of 6 min.
Time frame: Data collected at baseline and at completion of the 7-week intervention
Population: Changes in endurance as increase in walking distance relative to baseline (i.e., pre-training)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Robot-assisted Gait Training | Percent Change in 6-Minutes Walk Test | 23.5 percentage of baseline walking distance | Standard Deviation 37.7 |
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.
Time frame: Data collected at baseline and at completion of the 7-week intervention
Population: Changes in quality of gait as captured by the Edinburgh Visual Gait Scores (EVGS) relative to baseline (i.e., pre-training) value
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Robot-assisted Gait Training | Percent Change in Edinburgh Visual Gait Scores (EVGS) | 16.7 percentage of baseline value | Standard Deviation 12.7 |