Trial Outcomes & Findings for Muscle Synergies During Gait in Children With Cerebral Palsy Undergoing Robot-assisted Gait Therapy (NCT NCT06156969)
NCT ID: NCT06156969
Last Updated: 2024-03-19
Results Overview
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.
COMPLETED
NA
19 participants
Data collected at baseline and at completion of the 7-week intervention
2024-03-19
Participant Flow
Participant milestones
| Measure |
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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|---|---|
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Overall Study
STARTED
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19
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Overall Study
COMPLETED
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13
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Overall Study
NOT COMPLETED
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6
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Muscle Synergies During Gait in Children With Cerebral Palsy Undergoing Robot-assisted Gait Therapy
Baseline characteristics by cohort
| Measure |
Robot-assisted Gait Training
n=13 Participants
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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Age, Continuous
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13.1 years
STANDARD_DEVIATION 3.4 • n=5 Participants
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Sex: Female, Male
Female
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8 Participants
n=5 Participants
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Sex: Female, Male
Male
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5 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Black or African American
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1 Participants
n=5 Participants
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Race (NIH/OMB)
White
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8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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2 Participants
n=5 Participants
|
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
United States
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13 participants
n=5 Participants
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Gross Motor Function Classification System (GMFCS)
Level I
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2 Participants
n=5 Participants
|
|
Gross Motor Function Classification System (GMFCS)
Level II
|
5 Participants
n=5 Participants
|
|
Gross Motor Function Classification System (GMFCS)
Level III
|
5 Participants
n=5 Participants
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|
Gross Motor Function Classification System (GMFCS)
Level IV
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1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Data collected at baseline and at completion of the 7-week interventionPopulation: Changes in the similarity of muscle synergies recorded from children with CP pre vs post-intervention using normative muscle synergies as a reference
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.
Outcome measures
| Measure |
Robot-assisted Gait Training
n=13 Participants
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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Change in Cosine Similarity of the Muscle Synergies of the Most Affected Lower Limb
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2 percentage of muscle synergies
Standard Deviation 6
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SECONDARY outcome
Timeframe: Data collected at baseline and at completion of the 7-week interventionPopulation: Changes in the Gross Motor Function Measure (GMFM) Dimension D score pre- vs post-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.
Outcome measures
| Measure |
Robot-assisted Gait Training
n=13 Participants
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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|---|---|
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Change in Gross Motor Function Measure (GMFM) Dimension D
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5.9 units on a scale
Standard Deviation 8.1
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SECONDARY outcome
Timeframe: Data collected at baseline and at completion of the 7-week interventionPopulation: Changes in Gross Motor Function Measure (GMFM) Dimension E pre- vs post-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.
Outcome measures
| Measure |
Robot-assisted Gait Training
n=13 Participants
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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|---|---|
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Change in Gross Motor Function Measure (GMFM) Dimension E
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10.0 units on a scale
Standard Deviation 9.3
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SECONDARY outcome
Timeframe: Data collected at baseline and at completion of the 7-week interventionPopulation: Changes in walking speed relative to baseline (i.e., pre-training)
Study staff will use a stopwatch to measure the time needed by study participants to cover a distance of 10 meters.
Outcome measures
| Measure |
Robot-assisted Gait Training
n=13 Participants
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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|---|---|
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Percent Change in 10-Meter Walk Test
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-0.8 percentage of baseline value
Standard Deviation 28.0
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SECONDARY outcome
Timeframe: Data collected at baseline and at completion of the 7-week interventionPopulation: Changes in endurance as increase in walking distance relative to baseline (i.e., pre-training)
Study staff will measure the distance walked by study participants during an interval of 6 min.
Outcome measures
| Measure |
Robot-assisted Gait Training
n=13 Participants
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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|---|---|
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Percent Change in 6-Minutes Walk Test
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23.5 percentage of baseline walking distance
Standard Deviation 37.7
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SECONDARY outcome
Timeframe: Data collected at baseline and at completion of the 7-week interventionPopulation: Changes in quality of gait as captured by the Edinburgh Visual Gait Scores (EVGS) relative to baseline (i.e., pre-training) value
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.
Outcome measures
| Measure |
Robot-assisted Gait Training
n=13 Participants
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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Percent Change in Edinburgh Visual Gait Scores (EVGS)
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16.7 percentage of baseline value
Standard Deviation 12.7
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Adverse Events
Robot-assisted Gait Training
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place