Back to resultsFES to Improve Crouch Gait in CP (CP FES Walking)
Primary Purpose
Cerebral Palsy, Gait
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Functional Electrical Stimulation.
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring Cerebral Palsy, Functional electrical stimulation, Neurotherapeutic
Eligibility Criteria
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Shriners Hospitals for Children, Philadelphia
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Functional Electrical Stimulation protocol
Arm Description
Participants will be evaluated with and without the use of functional electrical stimulation while walking to determine the neuroprosthetic and neurotherapeutic effects.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04209257
First Posted
December 12, 2019
Last Updated
December 26, 2019
Sponsor
Shriners Hospitals for Children
1. Study Identification
Unique Protocol Identification Number
NCT04209257
Brief Title
FES to Improve Crouch Gait in CP
Acronym
CP FES Walking
Official Title
Functional Electrical Stimulation to Improve Crouch Gait in Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shriners Hospitals for Children
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Gait
Keywords
Cerebral Palsy, Functional electrical stimulation, Neurotherapeutic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Functional Electrical Stimulation protocol
Arm Type
Experimental
Arm Description
Participants will be evaluated with and without the use of functional electrical stimulation while walking to determine the neuroprosthetic and neurotherapeutic effects.
Intervention Type
Device
Intervention Name(s)
Functional Electrical Stimulation.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the Muscle Tone
Description
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.
Time Frame
Change from the baseline Modified Ashworth Scale at 14 weeks (post training)
Title
Change in the Muscle Tone
Description
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.
Time Frame
Change from the baseline Modified Ashworth Scale at 27 weeks (Follow up)
Title
Metabolic Cost of Walking
Description
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.
Time Frame
Change from the baseline Metabolic Cost of Walking at 14 weeks (post training)
Title
Metabolic Cost of Walking
Description
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.
Time Frame
Change from the baseline Metabolic Cost of Walking at 27 weeks (Follow up)
Title
Change in the Walking Speed
Description
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.
Time Frame
Change from the baseline Walking speed at 14 weeks (Post training)
Title
Change in the Walking Speed
Description
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.
Time Frame
Change from the baseline Walking speed at 27 weeks (Follow up)
Title
Change in the Walking Distance
Description
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.
Time Frame
Change from the baseline Walking Distance at 14 weeks (Post training)
Title
Change in the Walking Distance
Description
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.
Time Frame
Change from the baseline Walking Distance at 27 weeks (Follow up)
Title
Change in Gross Motor Function Measure
Description
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.
Time Frame
Change from the baseline GMFM score at 14 weeks (Post training)
Title
Change in Gross Motor Function Measure
Description
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.
Time Frame
Change from the baseline GMFM score at 27 weeks (Follow up)
Title
Change in the Timed Up-And-Go (TUG time)
Description
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.
Time Frame
Change from the baseline Time Up and Go time at 14 weeks (Post training)
Title
Change in the Timed Up-And-Go (TUG time)
Description
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.
Time Frame
Change from the baseline Time Up and Go time at 27 weeks (Follow up)
Title
Change in the Mini Balance Evaluation Systems Test Score
Description
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.
Time Frame
Change from the baseline Mini BESTest score at 14 weeks (Post training)
Title
Change in the Mini Balance Evaluation Systems Test Score
Description
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.
Time Frame
Change from the baseline Mini BESTest score at 27 weeks (Follow up)
Title
Change in the Electromyography
Description
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.
Time Frame
Change from the baseline Muscle activation at 14 weeks (Post training)
Title
Change in the Electromyography
Description
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.
Time Frame
Change from the baseline Muscle activation at 27 weeks (Follow up)
Title
Changes in the Activities-Specific Balance Scale Score
Description
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.
Time Frame
Change from the baseline ABC scale score at 14 weeks (Post training)
Title
Changes in the Activities-Specific Balance Scale Score
Description
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.
Time Frame
Change from the baseline ABC scale score at 27 weeks (Follow up)
Title
Changes in the Participation in Life Events survey score
Description
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.
Time Frame
Change from the baseline LIFE-H scale score at 14 weeks (Post training)
Title
Changes in the Participation in Life Events survey score
Description
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.
Time Frame
Change from the baseline LIFE-H scale score at 27 weeks (Follow up)
Title
Change in Piers-Harris Children's Self-Concept Scale score
Description
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.
Time Frame
Change from the baseline Piers-Harris Children's Self-Concept scale score at 14 weeks (Post training)
Title
Change in Piers-Harris Children's Self-Concept Scale score
Description
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.
Time Frame
Change from the baseline Piers-Harris Children's Self-Concept scale score at 27 weeks (Follow up)
Title
Change in Joint angles
Description
Hip, Knee and Ankle Joint Angles (Kinematic data) are measured using Instrumented gait analysis (Motion capture analysis system) during seven different gait phases.
Time Frame
Change from the baseline Joint angles at 14 weeks (Post training)
Title
Change in Joint angles
Description
Hip, Knee and Ankle Joint Angles (Kinematic data) are measured using Instrumented gait analysis (Motion capture analysis system) during seven different gait phases.
Time Frame
Change from the baseline joint angles at 27 weeks (Follow up)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
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
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel Lee, PT, PhD
Organizational Affiliation
Shriners Hospital for Children & University of Delaware
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shriners Hospitals for Children, Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Study protocol and data will be shared on publication of primary results
Links:
URL
http://sites.udel.edu/pt/dr-samuel-lee/
Description
Dr. Lee's current research studies
Learn more about this trial
FES to Improve Crouch Gait in CP
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