Asymmetrical Gait Training After Pediatric Stroke
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ClinicalTrials.gov Identifier: NCT01827436 |
Recruitment Status :
Completed
First Posted : April 9, 2013
Last Update Posted : January 5, 2018
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Condition or disease | Intervention/treatment | Phase |
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Stroke Hemiplegia | Behavioral: Conventional physical therapy Behavioral: Asymmetrical gait training | Early Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 9 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Motor Outcomes and Neural Correlates of Asymmetrical Gait Training in Children With Acquired Hemiplegia |
Study Start Date : | April 2013 |
Actual Primary Completion Date : | December 2016 |
Actual Study Completion Date : | December 2016 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Conventional physical therapy
Includes traditional physical treatment, such as gait and balance training and muscle strengthening.
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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.
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Behavioral: Asymmetrical gait training |
- Change in walking symmetry [ Time Frame: before and after 8 weeks of therapy ]
- Change in walking speed [ Time Frame: before and after 8 weeks of therapy ]
- Change in excitability of neural motor pathways [ Time Frame: before and after 8 weeks of therapy ]
- Change in patient/parent satisfaction rating [ Time Frame: before and after 8 weeks of therapy ]
- Change in community step activity [ Time Frame: before and after 8 weeks of therapy ]
- 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 ]

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Ages Eligible for Study: | 5 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01827436
United States, Pennsylvania | |
The Children's Hospital of Philadelphia | |
Philadelphia, Pennsylvania, United States, 19104 |
Principal Investigator: | Laura A Prosser, PhD, PT | Children's Hospital of Philadelphia |
Responsible Party: | Children's Hospital of Philadelphia |
ClinicalTrials.gov Identifier: | NCT01827436 |
Other Study ID Numbers: |
12-009844 |
First Posted: | April 9, 2013 Key Record Dates |
Last Update Posted: | January 5, 2018 |
Last Verified: | January 2018 |
pediatric stroke hemiplegia physical therapy |
gait training transcranial magnetic stimulation gait asymmetry |
Stroke Hemiplegia Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Paralysis Neurologic Manifestations |