Cerebral PalsyCP FES WalkingNCT04209257
FES to Improve Crouch Gait in CP
A study testing Functional Electrical Stimulation. in people with Cerebral Palsy and Gait, run by Shriners Hospitals for Children at 1 site in United States.
Trial summary
The overall goal of the proposed work is to develop and to assess the feasibility of using functional electrical stimulation (FES) system to improve crouch gait in individuals with cerebral palsy that may prevent the typical downward spiral of walking function decline in individuals with CP that occurs from… Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy, Gait
- What is being tested?
- Functional Electrical Stimulation.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age 10-18
- Spastic CP (di-, tetra-, or triplegia)
- Levels I-II GMFCS classification
- Sufficient covering of the femoral head in the acetabulum (migration % < 40)
- Mild crouch gait (minimum knee flexion 21-40o during stance)
- Potential to gain > 20 degrees knee extension improvement in stance phase
Show all 9Show fewer
- Minimum of 0o ankle dorsiflexion passive range of motion (PROM)
- Visual, perceptual, cognitive, and communication skills to follow multiple step commands for attending to exercise and data collection
- Seizure-free or well controlled seizures
Who cannot join
- Athetoid, ataxic, or hemiplegic CP
- Significant scoliosis (primary curve > 40°)
- Spinal fusions extending into the pelvis
- Severe tactile hypersensitivity
- Joint instability or dislocation in lower extremity
- Lower extremity surgery or fractures in the past year
Show all 13Show fewer
- Botox injections to Lower extremity in the past 6 months
- Implanted medical device contraindicated with application of FES
- Severe spasticity in Lower extremity (Mod Ashworth 4)
- Lower extremity joint pain during walking
- Hx of pulmonary disease limiting exercise tolerance or Hx of cardiac disease
- Severely limited range of motion / contractures (>15o knee flex or >15o hip flex contractures)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Shriners Hospitals for Children, Philadelphia
Philadelphia, Pennsylvania, 19140
About this study
Official title: Functional Electrical Stimulation to Improve Crouch Gait in Cerebral Palsy
The overall goal of the proposed work is to develop and to assess the feasibility of using functional electrical stimulation (FES) system to improve crouch gait in individuals with cerebral palsy that may prevent the typical downward spiral of walking function decline in individuals with CP that occurs from adolescence into adulthood.
Read the detailed description
Aim 1: To assess the feasibility of using a multiple channel FES system to produce an immediate neuroprosthetic effect to reduce crouch gait in children and adolescents with spastic diplegic CP.
Aim 2: To assess the feasibility of using a multiple channel FES system as a therapeutic training tool to produce lasting neurotherapeutic effects of diminished crouch gait in children and adolescents with CP.
- Conditions
- Cerebral Palsy, Gait
- Being tested
- Functional Electrical Stimulation.
- Keywords
- Cerebral Palsy, Functional electrical stimulation, Neurotherapeutic
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Electrical Stimulation.Device
Functional electrical stimulation - electrical stimulation applied to a muscle during an activity (i.e. ankle dorsiflexors during swing phase of gait). It assists / elicits muscle activation in order to achieve a task.
| Study group | Role | What they receive |
|---|---|---|
| Functional Electrical Stimulation protocol | Experimental | Participants will be evaluated with and without the use of functional electrical stimulation while walking to determine the neuroprosthetic and neurotherapeutic effects. Receives: Device: Functional Electrical Stimulation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Muscle Tone
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.
Measured: Change from the baseline Modified Ashworth Scale at 14 weeks (post training)
Change in the Muscle Tone
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.
Measured: Change from the baseline Modified Ashworth Scale at 27 weeks (Follow up)
Metabolic Cost of Walking
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.
Measured: Change from the baseline Metabolic Cost of Walking at 14 weeks (post training)
Metabolic Cost of Walking
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.
Measured: Change from the baseline Metabolic Cost of Walking at 27 weeks (Follow up)
Change in the Walking Speed
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.
Measured: Change from the baseline Walking speed at 14 weeks (Post training)
Change in the Walking Speed
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.
Measured: Change from the baseline Walking speed at 27 weeks (Follow up)
Change in the Walking Distance
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.
Measured: Change from the baseline Walking Distance at 14 weeks (Post training)
Change in the Walking Distance
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.
Measured: Change from the baseline Walking Distance at 27 weeks (Follow up)
Change in Gross Motor Function Measure
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.
Measured: Change from the baseline GMFM score at 14 weeks (Post training)
Change in Gross Motor Function Measure
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.
Measured: Change from the baseline GMFM score at 27 weeks (Follow up)
Change in the Timed Up-And-Go (TUG time)
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.
Measured: Change from the baseline Time Up and Go time at 14 weeks (Post training)
Change in the Timed Up-And-Go (TUG time)
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.
Measured: Change from the baseline Time Up and Go time at 27 weeks (Follow up)
Change in the Mini Balance Evaluation Systems Test Score
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.
Measured: Change from the baseline Mini BESTest score at 14 weeks (Post training)
Change in the Mini Balance Evaluation Systems Test Score
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.
Measured: Change from the baseline Mini BESTest score at 27 weeks (Follow up)
Change in the Electromyography
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.
Measured: Change from the baseline Muscle activation at 14 weeks (Post training)
Change in the Electromyography
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.
Measured: Change from the baseline Muscle activation at 27 weeks (Follow up)
Changes in the Activities-Specific Balance Scale Score
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.
Measured: Change from the baseline ABC scale score at 14 weeks (Post training)
Changes in the Activities-Specific Balance Scale Score
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.
Measured: Change from the baseline ABC scale score at 27 weeks (Follow up)
Changes in the Participation in Life Events survey score
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.
Measured: Change from the baseline LIFE-H scale score at 14 weeks (Post training)
Changes in the Participation in Life Events survey score
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.
Measured: Change from the baseline LIFE-H scale score at 27 weeks (Follow up)
Change in Piers-Harris Children's Self-Concept Scale score
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.
Measured: Change from the baseline Piers-Harris Children's Self-Concept scale score at 14 weeks (Post training)
Change in Piers-Harris Children's Self-Concept Scale score
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.
Measured: Change from the baseline Piers-Harris Children's Self-Concept scale score at 27 weeks (Follow up)
Change in Joint angles
Hip, Knee and Ankle Joint Angles (Kinematic data) are measured using Instrumented gait analysis (Motion capture analysis system) during seven different gait phases.
Measured: Change from the baseline Joint angles at 14 weeks (Post training)
Change in Joint angles
Hip, Knee and Ankle Joint Angles (Kinematic data) are measured using Instrumented gait analysis (Motion capture analysis system) during seven different gait phases.
Measured: Change from the baseline joint angles at 27 weeks (Follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study startJan 2012
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shriners Hospitals for Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuel C.K. Lee, PhD, PT, University of Delaware
- Investigators
- Samuel Lee, PT, PhD, Principal investigator, Shriners Hospital for Children & University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04209257
- Sponsor's protocol ID
- 71011-PHI
- Acronym
- CP FES Walking
- Status last verified
- Dec 2019
- First submitted
- 12 Dec 2019
- Last updated
- 30 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The proposed experiments will generate data for publications in high quality peer reviewed journals. We will also present our findings at national meetings of neurorehabilitation scientists and clinicians and neuroscience and motor control meetings. To have the most impact, it is important that we present our findings to both clinicians and scientists, therefore, in addition to these standard approaches, we will seek out regular opportunities to present both the rationale and results of our work to local and regional clinicians as well as local and regional stroke support groups. Once the primary hypotheses of the current proposal are tested, all data will be de-identified and be deposited in the DASH (The Data and Specimen Hub) repository.
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Electrical Stimulation to Improve Crouch Gait in Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04209257
- Acronym / sponsor ID
- CP FES Walking / 71011-PHI
- Conditions
- Cerebral Palsy, Gait
- Keywords
- Cerebral Palsy, Functional electrical stimulation, Neurotherapeutic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Shriners Hospitals for ChildrenUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 24 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall goal of the proposed work is to develop and to assess the feasibility of using functional electrical stimulation (FES) system to improve crouch gait in individuals with cerebral palsy that may prevent the typical downward spiral of walking function decline in individuals with CP that occurs from adolescence into adulthood.
Detailed description
Aim 1: To assess the feasibility of using a multiple channel FES system to produce an immediate neuroprosthetic effect to reduce crouch gait in children and adolescents with spastic diplegic CP.
Aim 2: To assess the feasibility of using a multiple channel FES system as a therapeutic training tool to produce lasting neurotherapeutic effects of diminished crouch gait in children and adolescents with CP.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Functional Electrical Stimulation protocol | Experimental | Device: Functional Electrical Stimulation.Participants will be evaluated with and without the use of functional electrical stimulation while walking to determine the neuroprosthetic and neurotherapeutic effects. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Age 10-18
- Spastic CP (di-, tetra-, or triplegia)
- Levels I-II GMFCS classification
- Sufficient covering of the femoral head in the acetabulum (migration % < 40)
- Mild crouch gait (minimum knee flexion 21-40o during stance)
Key exclusion criteria (13 listed)
- Athetoid, ataxic, or hemiplegic CP
- Significant scoliosis (primary curve > 40°)
- Spinal fusions extending into the pelvis
- Severe tactile hypersensitivity
- Joint instability or dislocation in lower extremity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional Electrical Stimulation.Functional electrical stimulation - electrical stimulation applied to a muscle during an activity (i.e. ankle dorsiflexors during swing phase of gait). It assists / elicits muscle activation in order to achieve a task. | Device | Functional Electrical Stimulation protocol |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2019.
- Dr. Lee's current research studiesLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The proposed experiments will generate data for publications in high quality peer reviewed journals. We will also present our findings at national meetings of neurorehabilitation scientists and clinicians and neuroscience and motor control meetings. To have the most impact, it is important that we present our findings to both clinicians and scientists, therefore, in addition to these standard approaches, we will seek out regular opportunities to present both the rationale and results of our work to local and regional clinicians as well as local and regional stroke support groups. Once the primary hypotheses of the current proposal are tested, all data will be de-identified and be deposited in the DASH (The Data and Specimen Hub) repository.
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Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
Cerebral Palsy
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel Lee, PT, PhD principal investigator
Shriners Hospital for Children & University of Delaware
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Electrical Stimulation. in people with Cerebral Palsy and Gait, run by Shriners Hospitals for Children at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Muscle Tone (time frame: Change from the baseline Modified Ashworth Scale at 14 weeks (post training)). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2019.