Asymmetrical Gait Training After Pediatric Stroke

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Children's Hospital of Philadelphia
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT01827436
First received: April 5, 2013
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Stroke
Hemiplegia
Behavioral: Conventional physical therapy
Behavioral: Asymmetrical gait training
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Motor Outcomes and Neural Correlates of Asymmetrical Gait Training in Children With Acquired Hemiplegia

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • Change in walking symmetry [ Time Frame: before and after 8 weeks of therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in walking speed [ Time Frame: before and after 8 weeks of therapy ] [ Designated as safety issue: No ]
  • Change in excitability of neural motor pathways [ Time Frame: before and after 8 weeks of therapy ] [ Designated as safety issue: No ]
  • Change in patient/parent satisfaction rating [ Time Frame: before and after 8 weeks of therapy ] [ Designated as safety issue: No ]
  • Change in community step activity [ Time Frame: before and after 8 weeks of therapy ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: April 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Conventional physical therapy
Includes traditional physical treatment, such as gait and balance training and muscle strengthening.
Behavioral: Conventional physical therapy
Active Comparator: Asymmetrical gait training
Includes walking on a split-belt treadmill with the belts moving at different speeds under each leg, alternated with overground walking training.
Behavioral: Asymmetrical gait training

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.

  Eligibility

Ages Eligible for Study:   5 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01827436

Contacts
Contact: Laura A Prosser, PhD, PT 215-590-2495 prosserl@email.chop.edu

Locations
United States, Pennsylvania
The Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Principal Investigator: Laura A Prosser, PhD, PT Children's Hospital of Philadelphia
  More Information

Additional Information:
No publications provided

Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01827436     History of Changes
Other Study ID Numbers: 12-009844
Study First Received: April 5, 2013
Last Updated: February 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital of Philadelphia:
pediatric stroke
hemiplegia
physical therapy
gait training
transcranial magnetic stimulation
gait asymmetry

Additional relevant MeSH terms:
Hemiplegia
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Neurologic Manifestations
Paralysis
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014