NCT01827436

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for early_phase_1 stroke

Timeline
Completed

Started Apr 2013

Typical duration for early_phase_1 stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 9, 2013

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 5, 2018

Status Verified

January 1, 2018

Enrollment Period

3.7 years

First QC Date

April 5, 2013

Last Update Submit

January 3, 2018

Conditions

StrokeHemiplegia

Keywords

pediatric strokehemiplegiaphysical therapygait trainingtranscranial magnetic stimulationgait asymmetry

Outcome Measures

Primary Outcomes (1)

  • Change in walking symmetry

    before and after 8 weeks of therapy

Secondary Outcomes (4)

  • Change in walking speed

    before and after 8 weeks of therapy

  • Change in excitability of neural motor pathways

    before and after 8 weeks of therapy

  • Change in patient/parent satisfaction rating

    before and after 8 weeks of therapy

  • Change in community step activity

    before and after 8 weeks of therapy

Other Outcomes (1)

  • Changes in walking ability and cortical excitability measures (detailed above)

    before and after a 4 week baseline phase; before and after a 4 week withdraw phase

Study Arms (2)

Conventional physical therapy

ACTIVE COMPARATOR

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

Behavioral: Conventional physical therapy

Asymmetrical gait training

ACTIVE COMPARATOR

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

Interventions

Conventional physical therapyBEHAVIORAL
Conventional physical therapy
Asymmetrical gait trainingBEHAVIORAL
Asymmetrical gait training

Eligibility Criteria

Age5 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Links

MeSH Terms

Conditions

StrokeHemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Laura A Prosser, PhD, PT

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2013

First Posted

April 9, 2013

Study Start

April 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 5, 2018

Record last verified: 2018-01

Locations

US(1)