FES to Improve Crouch Gait in CP

Primary outcomes

1. Change in the Muscle Tone

   Time frame: Change from the baseline Modified Ashworth Scale at 14 weeks (post training)

   We use the Modified Ashworth Scale to measure resistance to passive movement about a joint with varying degree of velocity (Muscle tone/spasticity). Score ranges from 0-4, with 6 choices where score of 0 means no increase in tone and score of 4 means rigid limb with no flexion or extension. Our training approach using repetitive electrical stimulation may also lower spasticity, which can also facilitate improved functional mobility.

2. Change in the Muscle Tone

   Time frame: Change from the baseline Modified Ashworth Scale at 27 weeks (Follow up)

   We use the Modified Ashworth Scale to measure resistance to passive movement about a joint with varying degree of velocity (Muscle tone/spasticity). Score ranges from 0-4, with 6 choices where score of 0 means no increase in tone and score of 4 means rigid limb with no flexion or extension. Our training approach using repetitive electrical stimulation may also lower spasticity, which can also facilitate improved functional mobility.

3. Metabolic Cost of Walking

   Time frame: Change from the baseline Metabolic Cost of Walking at 14 weeks (post training)

   Walking Energy Expenditure will be measured via indirect calorimetry at the subject's self-selected walking speed. The subject will walk on the treadmill while breathing into a VMax gas-dilution SensorMedics metabolic measurement system. The subject will warm up at a slow walking speed for 3 minutes, walk for approximately 5 minutes at the subject's self-selected walking speed until steady state is reached, and then sit for a 3-minute cool down. The metabolic cost of walking is computed over the 5-minute walking period.

4. Metabolic Cost of Walking

   Time frame: Change from the baseline Metabolic Cost of Walking at 27 weeks (Follow up)

   Walking Energy Expenditure will be measured via indirect calorimetry at the subject's self-selected walking speed. The subject will walk on the treadmill while breathing into a VMax gas-dilution SensorMedics metabolic measurement system. The subject will warm up at a slow walking speed for 3 minutes, walk for approximately 5 minutes at the subject's self-selected walking speed until steady state is reached, and then sit for a 3-minute cool down. The metabolic cost of walking is computed over the 5-minute walking period.

5. Change in the Walking Speed

   Time frame: Change from the baseline Walking speed at 14 weeks (Post training)

   Walking Speed is measured via the 10-meter walk test. This time taken to complete the task is used to compute the average walking speed referred to as "self-selected" walking speed.

6. Change in the Walking Speed

   Time frame: Change from the baseline Walking speed at 27 weeks (Follow up)

   Walking Speed is measured via the 10-meter walk test. This time taken to complete the task is used to compute the average walking speed referred to as "self-selected" walking speed.

7. Change in the Walking Distance

   Time frame: Change from the baseline Walking Distance at 14 weeks (Post training)

   Walking distance (in a fixed period of time) is an indicator of endurance. Walking Distance is measured via the 6-minute walk test. Improved motor learning and gait biomechanics from the training methods would improve gait efficiency and thus, endurance.

8. Change in the Walking Distance

   Time frame: Change from the baseline Walking Distance at 27 weeks (Follow up)

   Walking distance (in a fixed period of time) is an indicator of endurance. Walking Distance is measured via the 6-minute walk test. Improved motor learning and gait biomechanics from the training methods would improve gait efficiency and thus, endurance.

9. Change in Gross Motor Function Measure

   Time frame: Change from the baseline GMFM score at 14 weeks (Post training)

   Gross Motor Function will be assessed via sections D and E of the Gross Motor Function Measure (GMFM) test. This test is designed to evaluate changes in gross motor function over time of children with CP.

10. Change in Gross Motor Function Measure

    Time frame: Change from the baseline GMFM score at 27 weeks (Follow up)

    Gross Motor Function will be assessed via sections D and E of the Gross Motor Function Measure (GMFM) test. This test is designed to evaluate changes in gross motor function over time of children with CP.

11. Change in the Timed Up-And-Go (TUG time)

    Time frame: Change from the baseline Time Up and Go time at 14 weeks (Post training)

    Timed Up-And-Go (TUG) is a measure designed to assess functional mobility and balance. The subjects will be seated on an adjustable bench such that the knees and angles are at 90 degrees. Subjects will be timed as they rise, walk 3 meters, turn around, return to the bench and sit down again.assessing the impact of anticipated improvements in motor control and gait biomechanics.

12. Change in the Timed Up-And-Go (TUG time)

    Time frame: Change from the baseline Time Up and Go time at 27 weeks (Follow up)

    Timed Up-And-Go (TUG) is a measure designed to assess functional mobility and balance. The subjects will be seated on an adjustable bench such that the knees and angles are at 90 degrees. Subjects will be timed as they rise, walk 3 meters, turn around, return to the bench and sit down again.assessing the impact of anticipated improvements in motor control and gait biomechanics.

13. Change in the Mini Balance Evaluation Systems Test Score

    Time frame: Change from the baseline Mini BESTest score at 14 weeks (Post training)

    Balance Evaluation Systems Test (BESTest) is a measure of balance function. The BESTest will allow for assessing the impact of anticipated improvements in motor control and gait biomechanics from training on balance. The test has a maximum score of 28 points and minimum score of zero. Score of 28 means highest level of function and 0 means lowest level of function.

14. Change in the Mini Balance Evaluation Systems Test Score

    Time frame: Change from the baseline Mini BESTest score at 27 weeks (Follow up)

    Balance Evaluation Systems Test (BESTest) is a measure of balance function. The BESTest will allow for assessing the impact of anticipated improvements in motor control and gait biomechanics from training on balance. The test has a maximum score of 28 points and minimum score of zero. Score of 28 means highest level of function and 0 means lowest level of function.

15. Change in the Electromyography

    Time frame: Change from the baseline Muscle activation at 14 weeks (Post training)

    Muscle activation timing measured with Electromyography during gait analysis allows for mechanistic study of anticipated improvements in motor control and gait as well as comparison to typical norms.

16. Change in the Electromyography

    Time frame: Change from the baseline Muscle activation at 27 weeks (Follow up)

    Muscle activation timing measured with Electromyography during gait analysis allows for mechanistic study of anticipated improvements in motor control and gait as well as comparison to typical norms.

17. Changes in the Activities-Specific Balance Scale Score

    Time frame: Change from the baseline ABC scale score at 14 weeks (Post training)

    The Activities-Specific Balance Scale (ABC Scale) survey allows measurement of perceived functional mobility by assessing balance confidence to perform daily activities of living without falling. 16 items are rated on a rating scale with range of 0-100. Score of 0 means no confidence and 100 means complete confidence. Average score of 16 items is the overall score. Such measures will assess the impact of anticipated improvements in motor control and gait bio-mechanics from training.

18. Changes in the Activities-Specific Balance Scale Score

    Time frame: Change from the baseline ABC scale score at 27 weeks (Follow up)

    The Activities-Specific Balance Scale (ABC Scale) survey allows measurement of perceived functional mobility by assessing balance confidence to perform daily activities of living without falling. 16 items are rated on a rating scale with range of 0-100. Score of 0 means no confidence and 100 means complete confidence. Average score of 16 items is the overall score. Such measures will assess the impact of anticipated improvements in motor control and gait bio-mechanics from training.

19. Changes in the Participation in Life Events survey score

    Time frame: Change from the baseline LIFE-H scale score at 14 weeks (Post training)

    Participation in life events (LIFE-H) survey measures how much a person is engaging or participating with their peers and community. Weighted score ranges between 0-10 with 0 score being no accomplishment and 10 means complete accomplishment. Such measures will assess the impact of anticipated improvements in motor control and gait biomechanics from training.

20. Changes in the Participation in Life Events survey score

    Time frame: Change from the baseline LIFE-H scale score at 27 weeks (Follow up)

    Participation in life events (LIFE-H) survey measures how much a person is engaging or participating with their peers and community. Weighted score ranges between 0-10 with 0 score being no accomplishment and 10 means complete accomplishment. Such measures will assess the impact of anticipated improvements in motor control and gait biomechanics from training.

21. Change in Piers-Harris Children's Self-Concept Scale score

    Time frame: Change from the baseline Piers-Harris Children's Self-Concept scale score at 14 weeks (Post training)

    Self-Perception will be measured via the Piers-Harris Children's Self-Concept Scale, Second Edition (Piers-Harris 2). This test is designed to measure self-concept as reported by the individual. It measures physical and emotional well-being and self-esteem and will allow assessment of the impact of anticipated improvements in motor control and gait biomechanics from training. The tool consists of 60 items that require the respondent to respond by circling "Yes" or "No." Raw scores are converted to standardized t-scores (mean = 50, standard deviation = 10) and percentile ranks. T-Score ranges for the total scale are: <29T is very low, 30T-39T is low, 40T-44T is low average, 45T-55T average, 56T-59T- is high average, 60T-69T is high and > 70T is very high. For the six subscales T-Score ranges < 29T is very low, 30T-39T is low, 40T-44T is low average, 45T-55T is average and > 56T is above average.

22. Change in Piers-Harris Children's Self-Concept Scale score

    Time frame: Change from the baseline Piers-Harris Children's Self-Concept scale score at 27 weeks (Follow up)

    Self-Perception will be measured via the Piers-Harris Children's Self-Concept Scale, Second Edition (Piers-Harris 2). This test is designed to measure self-concept as reported by the individual. It measures physical and emotional well-being and self-esteem and will allow assessment of the impact of anticipated improvements in motor control and gait biomechanics from training. The tool consists of 60 items that require the respondent to respond by circling "Yes" or "No." Raw scores are converted to standardized t-scores (mean = 50, standard deviation = 10) and percentile ranks. T-Score ranges for the total scale are: <29T is very low, 30T-39T is low, 40T-44T is low average, 45T-55T average, 56T-59T- is high average, 60T-69T is high and > 70T is very high. For the six subscales T-Score ranges < 29T is very low, 30T-39T is low, 40T-44T is low average, 45T-55T is average and > 56T is above average.

23. Change in Joint angles

    Time frame: Change from the baseline Joint angles at 14 weeks (Post training)

    Hip, Knee and Ankle Joint Angles (Kinematic data) are measured using Instrumented gait analysis (Motion capture analysis system) during seven different gait phases.

24. Change in Joint angles

    Time frame: Change from the baseline joint angles at 27 weeks (Follow up)

    Hip, Knee and Ankle Joint Angles (Kinematic data) are measured using Instrumented gait analysis (Motion capture analysis system) during seven different gait phases.