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Asymmetrical Gait Training After Pediatric Stroke

Primary Purpose

Stroke, Hemiplegia

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Conventional physical therapy
Asymmetrical gait training
Sponsored by
Children's Hospital of Philadelphia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring pediatric stroke, hemiplegia, physical therapy, gait training, transcranial magnetic stimulation, gait asymmetry

Eligibility Criteria

5 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Between 5-17 years of age
  2. History of unilateral supratentorial arterial ischemic or hemorrhagic stroke
  3. Onset of stroke at least 6 months before study enrollment
  4. Ability to walk at least 20 feet without the use of an assistive device
  5. At least a 5 second difference in single leg stance time between left and right sides
  6. The ability to return to the Children's Hospital of Philadelphia (CHOP) for the proposed training and testing sessions
  7. Parental/guardian permission (informed consent) and if appropriate, child assent

Exclusion Criteria:

  1. Intracranial metallic or magnetic object or implanted electrical pacing device
  2. Treatment with botulinum toxin injections to the more affected ankle plantarflexors in the past 3 months
  3. Cognitive impairment that would prevent completion of the required training and testing activities
  4. Parents/guardians or participants who, in the opinion of the investigator, may not adhere with study schedules or procedures

Sites / Locations

  • The Children's Hospital of Philadelphia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Conventional physical therapy

Asymmetrical gait training

Arm Description

Includes traditional physical treatment, such as gait and balance training and muscle strengthening.

Includes walking on a split-belt treadmill with the belts moving at different speeds under each leg, alternated with overground walking training.

Outcomes

Primary Outcome Measures

Change in walking symmetry

Secondary Outcome Measures

Change in walking speed
Change in excitability of neural motor pathways
Change in patient/parent satisfaction rating
Change in community step activity

Full Information

First Posted
April 5, 2013
Last Updated
January 3, 2018
Sponsor
Children's Hospital of Philadelphia
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1. Study Identification

Unique Protocol Identification Number
NCT01827436
Brief Title
Asymmetrical Gait Training After Pediatric Stroke
Official Title
Motor Outcomes and Neural Correlates of Asymmetrical Gait Training in Children With Acquired Hemiplegia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purposes of this pilot research study are 1. To begin to test if two different types of physical therapy might have different results in children and adolescents who have had a prior stroke, and 2. To determine if either type of physical therapy causes changes in the brain signals that control leg muscles. All participants will receive physical therapy 3 times per week for 8 weeks. Half of the participants will receive typical physical therapy, such as walking practice, muscle strengthening, and balance training. Half of the participants will receive asymmetrical gait training physical therapy, which uses new technology to train each leg differently during walking practice. After enrolling, participants will be randomly assigned to the type of therapy. Measurements will be taken before, during, and after the 8 weeks of physical therapy. These include walking tests to measure symmetry, walking speed and daily step activity, and brain tests to measure the strength of the signals from the brain to the leg muscles. One blood test is also taken to identify if certain genetic factors affect how each child responds to the physical therapy.
Detailed Description
Effective rehabilitation after acquired brain injury is essential for reducing the impact of the leading cause of pediatric disability in the United States. Neuroplastic changes in response to physical therapy are likely different in children compared to adults because children are continuing to experience developmental brain maturation while also experiencing the neural changes associated with injury and rehabilitation. The interaction between these two processes is poorly understood but presumably critical for maximizing long term outcomes. Using biomarkers to measure and predict rehabilitation-induced changes will improve rehabilitation prognosis and will facilitate the development of rehabilitation interventions that optimize neuroplastic potential in children. The objectives of this pilot study are to investigate the motor and neural responses to two different rehabilitation programs in children and adolescents with chronic hemiplegia from prior stroke. Participants will be randomly assigned to receive conventional physical therapy or an asymmetrical gait training program. Conventional physical therapy will include activities such as gait and balance training and muscle strengthening. The asymmetrical gait training program uses new technology to train each leg at a different speed during walking practice. Measurements of motor and neural function will occur at five timepoints before, during and after treatment. Motor function measures will include gait symmetry ratios, walking speed, community step activity, and participant and caregiver ratings on self-identified walking goals. Neural measures will include motor response characteristics of muscle contractions elicited in two lower extremity muscles by transcranial magnetic stimulation of the injured cortex. We will also establish a genetic database to identify the presence or absence of two genetic variants [Apolipoprotein E (ApoE Є4) and val66met Brain-derived neurotropic factor (BDNF) polymorphisms] associated with decreased potential for neuroplasticity for planning future investigations. The results will be used to inform the design of larger studies evaluating physical therapy treatments that maximize the capacity of the child's brain to change after neurological injury and identifying predictors of rehabilitation-induced neuroplasticity in children.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiplegia
Keywords
pediatric stroke, hemiplegia, physical therapy, gait training, transcranial magnetic stimulation, gait asymmetry

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional physical therapy
Arm Type
Active Comparator
Arm Description
Includes traditional physical treatment, such as gait and balance training and muscle strengthening.
Arm Title
Asymmetrical gait training
Arm Type
Active Comparator
Arm Description
Includes walking on a split-belt treadmill with the belts moving at different speeds under each leg, alternated with overground walking training.
Intervention Type
Behavioral
Intervention Name(s)
Conventional physical therapy
Intervention Type
Behavioral
Intervention Name(s)
Asymmetrical gait training
Primary Outcome Measure Information:
Title
Change in walking symmetry
Time Frame
before and after 8 weeks of therapy
Secondary Outcome Measure Information:
Title
Change in walking speed
Time Frame
before and after 8 weeks of therapy
Title
Change in excitability of neural motor pathways
Time Frame
before and after 8 weeks of therapy
Title
Change in patient/parent satisfaction rating
Time Frame
before and after 8 weeks of therapy
Title
Change in community step activity
Time Frame
before and after 8 weeks of therapy
Other Pre-specified Outcome Measures:
Title
Changes in walking ability and cortical excitability measures (detailed above)
Time Frame
before and after a 4 week baseline phase; before and after a 4 week withdraw phase

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Between 5-17 years of age History of unilateral supratentorial arterial ischemic or hemorrhagic stroke Onset of stroke at least 6 months before study enrollment Ability to walk at least 20 feet without the use of an assistive device At least a 5 second difference in single leg stance time between left and right sides The ability to return to the Children's Hospital of Philadelphia (CHOP) for the proposed training and testing sessions Parental/guardian permission (informed consent) and if appropriate, child assent Exclusion Criteria: Intracranial metallic or magnetic object or implanted electrical pacing device Treatment with botulinum toxin injections to the more affected ankle plantarflexors in the past 3 months Cognitive impairment that would prevent completion of the required training and testing activities Parents/guardians or participants who, in the opinion of the investigator, may not adhere with study schedules or procedures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura A Prosser, PhD, PT
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.research.chop.edu/research/clinical-research
Description
Type "Prosser" in the Principal Investigator field and click Search

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Asymmetrical Gait Training After Pediatric Stroke

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