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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.
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:
Muscle activity tests:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paolo Bonato, PhD | Spaulding Rehabilitation Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spaulding Rehabilitation Hospital | Boston | Massachusetts | 02129 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Changes in the similarity of muscle synergies recorded from children with CP pre vs post-intervention using normative muscle synergies as a reference | Posted | Mean | Standard Deviation | percentage of muscle synergies | Data collected at baseline and at completion of the 7-week intervention |
|
From baseline to study completion, on average 7 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paolo Bonato, PhD | Spaulding Rehabilitation Hospital | 617-952-6319 | PBONATO@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 3, 2019 | Dec 26, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 3, 2019 | Feb 6, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Data collected at baseline and at completion of the 7-week intervention |
| 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. | Data collected at baseline and at completion of the 7-week intervention |
| 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. | Data collected at baseline and at completion of the 7-week intervention |
| Percent Change in 6-Minutes Walk Test | Study staff will measure the distance walked by study participants during an interval of 6 min. | Data collected at baseline and at completion of the 7-week intervention |
| 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. | Data collected at baseline and at completion of the 7-week intervention |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Gross Motor Function Classification System (GMFCS) | The Gross Motor Function Classification System (GMFCS is a five-level clinical classification system, from the least to the most severe, that describes the gross motor function of children and youth with cerebral palsy based on self-initiated movement abilities and the need for assistive devices such as walkers or wheelchairs. Level I: Walks without limitations; Level II: Walks with limitations; Level III: Walks using a hand-held mobility device; Level IV: Self-mobility with limitations; may use powered mobility; and Level V: Transported in manual wheelchair. | Count of Participants | Participants |
|
| 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. |
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| 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. | Changes in the Gross Motor Function Measure (GMFM) Dimension D score pre- vs post-intervention | Posted | Mean | Standard Deviation | units on a scale | Data collected at baseline and at completion of the 7-week intervention |
|
|
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| 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. | Changes in Gross Motor Function Measure (GMFM) Dimension E pre- vs post-intervention | Posted | Mean | Standard Deviation | units on a scale | Data collected at baseline and at completion of the 7-week intervention |
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| 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. | Changes in walking speed relative to baseline (i.e., pre-training) | Posted | Mean | Standard Deviation | percentage of baseline value | Data collected at baseline and at completion of the 7-week intervention |
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| Secondary | Percent Change in 6-Minutes Walk Test | Study staff will measure the distance walked by study participants during an interval of 6 min. | Changes in endurance as increase in walking distance relative to baseline (i.e., pre-training) | Posted | Mean | Standard Deviation | percentage of baseline walking distance | Data collected at baseline and at completion of the 7-week intervention |
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| 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. | Changes in quality of gait as captured by the Edinburgh Visual Gait Scores (EVGS) relative to baseline (i.e., pre-training) value | Posted | Mean | Standard Deviation | percentage of baseline value | Data collected at baseline and at completion of the 7-week intervention |
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