StrokeEarly Phase 1NCT01827436
Asymmetrical Gait Training After Pediatric Stroke
A Early Phase 1 study testing Conventional physical therapy and Asymmetrical gait training in people with Stroke and Hemiplegia, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Stroke, Hemiplegia
- What is being tested?
- Conventional physical therapy and Asymmetrical gait training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Dec 2016
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Motor Outcomes and Neural Correlates of Asymmetrical Gait Training in Children With Acquired Hemiplegia
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.
Read the 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.
- Conditions
- Stroke, Hemiplegia
- Being tested
- Conventional physical therapy, Asymmetrical gait training
- Keywords
- pediatric stroke, hemiplegia, physical therapy, gait training, transcranial magnetic stimulation, gait asymmetry
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional physical therapyBehavioural
Asymmetrical gait trainingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Conventional physical therapy | Active comparator | Includes traditional physical treatment, such as gait and balance training and muscle strengthening. Receives: 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. Receives: Behavioral: Asymmetrical gait training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in walking symmetry
Measured: before and after 8 weeks of therapy
Secondary outcomes (4)
Change in walking speed
Measured: before and after 8 weeks of therapy
Change in excitability of neural motor pathways
Measured: before and after 8 weeks of therapy
Change in patient/parent satisfaction rating
Measured: before and after 8 weeks of therapy
Change in community step activity
Measured: before and after 8 weeks of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura A Prosser, PhD, PT, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01827436
- Sponsor's protocol ID
- 12-009844
- Status last verified
- Jan 2018
- First submitted
- 5 Apr 2013
- Last updated
- 5 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor Outcomes and Neural Correlates of Asymmetrical Gait Training in Children With Acquired Hemiplegia
- ClinicalTrials.gov ID
- NCT01827436
- Acronym / sponsor ID
- 12-009844
- Conditions
- Stroke, Hemiplegia
- Keywords
- pediatric stroke, hemiplegia, physical therapy, gait training, transcranial magnetic stimulation, gait asymmetry
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 9 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional physical therapy | Active comparator | Behavioral: Conventional physical therapyIncludes traditional physical treatment, such as gait and balance training and muscle strengthening. |
| Asymmetrical gait training | Active comparator | Behavioral: Asymmetrical gait trainingIncludes walking on a split-belt treadmill with the belts moving at different speeds under each leg, alternated with overground walking training. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional physical therapy | Behavioural | Conventional physical therapy |
| Asymmetrical gait training | Behavioural | Asymmetrical gait training |
Primary outcome
Change in walking symmetry
Time frame: before and after 8 weeks of therapy
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2018.
- Type "Prosser" in the Principal Investigator field and click SearchLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura A Prosser, PhD, PT principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Conventional physical therapy and Asymmetrical gait training in people with Stroke and Hemiplegia, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in walking symmetry (time frame: before and after 8 weeks of therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2018.