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出境医 / 临床实验 / Short-Burst Interval Treadmill Training Cerebral Palsy
Short-Burst Interval Treadmill Training Cerebral Palsy
Study Description
Brief Summary:
Ambulatory children with cerebral palsy (CP) walk predominately in low intensity stride rates with little variability, thus limiting their walking activity and ability to participate in daily life. In contrast, typically developing (TD) children engage in short bursts of intense walking activity interspersed with varying intervals of low intensity walking within daily life. In order to optimize motor learning, active participation, task-specific training and multiple repetitions or massed practice is required to learn new motor skills. Short bursts of vigorous intensity locomotor treadmill training (SBLTT) alternating with low/moderate intensity was specifically designed to mimic activity patterns of TD children in a massed practice format. Pilot data suggests that SBLTT is feasible and enhances walking capacity and performance in daily life for children with CP. This project will examine the effect of SBLTT versus an equivalent dosage of traditional locomotor treadmill training (TLTT) on the primary outcomes of walking capacity and performance in children with CP and whether the effects of SBLTT on walking capacity and performance are mediated by improvements in in muscle power generation. The scientific premise is that SBLTT, that approximates the walking intensity patterns of typically developing (TD) children through a home-based massed practice protocol, will be more effective than TLTT in improving walking capacity and performance. We hypothesize that SBLTT strategies for children with CP modeled on walking patterns of TD children, will be positively mediated by muscle power generation and subsequently improve walking capacity and community walking performance and mobility. Specific aims. Aim #1. Determine the immediate and retention effects of short-burst interval LTT (SBLTT) on walking capacity in ambulatory children with CP. Aim #2. Examine the effects of treatment on community-based walking activity performance and mobility. Aim #3. Explore whether the effects of SBLTT on walking capacity and performance are mediated by muscle power generation. The proposed research will be the first step in a continuum of research that is expected to direct locomotor training protocols and rehab strategies across pediatric disabilities and positively effecting the community walking performance and mobility for children with CP.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cerebral Palsy | Behavioral: Short Burst Interval Treadmill Training (SBLTT) Behavioral: Traditional Locomotor Treadmill Training (TLTT) | Not Applicable |
Detailed Description:
In a randomized clinical trial, 72 ambulatory children with spastic CP (6-10 yrs.) will receive either SBLTT or an equivalent dosage of TLTT for 40 sessions, 5x/week for 8 weeks in a massed practice format. The only difference between training protocols will be the variable training (interval fast versus steady state walking speeds). Thus, the key ingredient will be the intensity of the interval training delivered in a serial blocked practice schedule. Outcomes will be collected at baseline, 4 and 8 weeks to assess dosage, and 24 weeks post training for long term retention with the primary endpoint at 8 weeks.
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 72 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Participants are randomized to either short-burst interval locomotor treadmill training (SBLTT) or traditional locomotor treadmill training (TLTT) |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Short-Burst Interval Treadmill Training to Improve Community Walking Activity and Mobility in Cerebral Palsy |
| Actual Study Start Date : | November 27, 2019 |
| Estimated Primary Completion Date : | January 31, 2024 |
| Estimated Study Completion Date : | January 31, 2025 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Short burst Interval Treadmill Training (SBLTT)
SBLTT will consist of short-bursts (30 seconds) of high speed walking alternating with 30 seconds of low/moderate speed walking. Participant will receive 40 home-based sessions (5x/week for 8 weeks) of SBLTT
|
Behavioral: Short Burst Interval Treadmill Training (SBLTT)
SBLTT will consist of short-bursts (30 seconds) of high speed walking alternating with 30 seconds of low/moderate speed walking. Total duration of walking per session will be up to 30 minutes of the 30 second alternating intervals (30sec high / 30sec low/moderate) with rests as needed. Both groups will receive 40 sessions delivered 5x/week for 8 weeks. Initial speeds for high speed walking will be 75-80% of each participant's over ground baseline fast walking speed, and low/moderate speed will be 75-80% of self-selected speed calculated from the 10-Meter Walk Test.
|
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Active Comparator: Traditional Locomotor Treadmill Training (TLTT)
TLTT will consist of walking at steady-state speeds. Participant will receive 40 home-based sessions (5x/week for 8 weeks) of TLTT
|
Behavioral: Traditional Locomotor Treadmill Training (TLTT)
TLTT group will receive the same number of sessions (40) delivered 5x/week for 8 weeks with a total duration of walking per session up to 30 minutes with rests as needed. TLTT will consist of walking at steady-state speeds. Initial treadmill speed will be 75-80% of over ground self-selected walking speed. The overall goal will be to achieve 30 minutes of walking at a steady-state walking speed within each session. Speed will be increased on the next session by .1 to .4mph when the subject can walk for 30 minutes on the treadmill at the current speed with an OMNI score of < 6/10.
|
Outcome Measures
Primary Outcome Measures :
- Walking Capacity-Self-selected walking spee [ Time Frame: Baseline to 8 weeks ]10 Meter Walk Test
- Walking Capacity-Fast walking speed [ Time Frame: Baseline to 8 weeks ]10 Meter Walk Test- fast speed
- Walking Capacity-Endurance [ Time Frame: Baseline to 8 weeks ]One Minute Walk Test
- Walking Performance-level [ Time Frame: Baseline to 8 weeks ]StepWatch (SW) accelerometry - average total steps per day
- Walking Performance-Intensity [ Time Frame: Baseline to 8 weeks ]StepWatch (SW) accelerometry - average daily steps at low, medium and high step rates
- Knee extensor muscle power [ Time Frame: Baseline to 8 weeks. ]Isokinetic Average Power for Knee extensors at 60deg/s as measured by Biodex.
Secondary Outcome Measures :
- Walking Mobility -level home versus community [ Time Frame: Baseline to 8 weeks ]StepWatch (SW) synchronized with Global Positioning System (GPS) - average strides per day in home versus community
- Walking Mobility-intensity home versus community [ Time Frame: Baseline to 8 weeks ]StepWatch (SW) synchronized with Global Positioning System (GPS) - average strides per day low, medium or high stride rate in home versus community
- Mobility [ Time Frame: Baseline to 8 weeks ]Patient-Reported Outcomes Measurement Information System (PROMIS v1.0 Pediatric Profile) Mobility domain score
- Family Gait Priorities and Quality of gait [ Time Frame: Baseline to 8 weeks ]Parent report Gait Outcome Assessment List (GOAL).total score
- Knee extensor muscle torque [ Time Frame: Baseline to 8 weeks. ]Isokinetic Peak Torque for knee extensors at 60 deg/s as measured by Biodex.
Eligibility Criteria
| Ages Eligible for Study: | 6 Years to 10 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Bilateral spastic cerebral palsy
- Gross Motor Function Classification Levels II & III
- Ages 6 years to < 11 years
Exclusion Criteria:
- Orthopedic or neurosurgery < 9 months prior
- Injection therapy (Botulinum Toxin/Phenol) < 3 months prior
Contacts and Locations
Contacts
| Contact: Kristie F Bjornson, PhD, PT | 206-8842066 | kristie.bjornson@seattlechildrens.org | |
| Contact: Neil Panlasigui, BS | 206-884-2066 | neil.panlasigui@seattlechildrens.org |
Locations
| United States, Louisiana | |
| Lousianna State University Health Sciences Center New Orleans | Recruiting |
| New Orleans, Louisiana, United States, 70112 | |
| Contact: Noelle Moreau, PhD, PT 504-568-4291 NMorea@lsuhsc.edu | |
| United States, Washington | |
| Seattle Childrens Research Institute | Recruiting |
| Seattle, Washington, United States, 98121 | |
| Contact: Kristie F Bjornson, PhD, PT 206-884-2066 kristie.bjornson@seattlechildrens.org | |
| Contact: Neil Panlasigui, BS 206-884-2066 neil.panlasigui@seattlechildrens.org | |
Sponsors and Collaborators
Kristie Bjornson
University of Washington
Louisiana State University Health Sciences Center in New Orleans
Investigators
| Principal Investigator: | Kristie F Bjornson, PhD, PT | Seattle Children's Research Institute | |
| Principal Investigator: | Noelle Moreau, PhD, PT | Lousianna State University in New Orleans |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 17, 2019 | ||||||||
| First Posted Date ICMJE | July 19, 2019 | ||||||||
| Last Update Posted Date | June 2, 2021 | ||||||||
| Actual Study Start Date ICMJE | November 27, 2019 | ||||||||
| Estimated Primary Completion Date | January 31, 2024 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Short-Burst Interval Treadmill Training Cerebral Palsy | ||||||||
| Official Title ICMJE | Short-Burst Interval Treadmill Training to Improve Community Walking Activity and Mobility in Cerebral Palsy | ||||||||
| Brief Summary | Ambulatory children with cerebral palsy (CP) walk predominately in low intensity stride rates with little variability, thus limiting their walking activity and ability to participate in daily life. In contrast, typically developing (TD) children engage in short bursts of intense walking activity interspersed with varying intervals of low intensity walking within daily life. In order to optimize motor learning, active participation, task-specific training and multiple repetitions or massed practice is required to learn new motor skills. Short bursts of vigorous intensity locomotor treadmill training (SBLTT) alternating with low/moderate intensity was specifically designed to mimic activity patterns of TD children in a massed practice format. Pilot data suggests that SBLTT is feasible and enhances walking capacity and performance in daily life for children with CP. This project will examine the effect of SBLTT versus an equivalent dosage of traditional locomotor treadmill training (TLTT) on the primary outcomes of walking capacity and performance in children with CP and whether the effects of SBLTT on walking capacity and performance are mediated by improvements in in muscle power generation. The scientific premise is that SBLTT, that approximates the walking intensity patterns of typically developing (TD) children through a home-based massed practice protocol, will be more effective than TLTT in improving walking capacity and performance. We hypothesize that SBLTT strategies for children with CP modeled on walking patterns of TD children, will be positively mediated by muscle power generation and subsequently improve walking capacity and community walking performance and mobility. Specific aims. Aim #1. Determine the immediate and retention effects of short-burst interval LTT (SBLTT) on walking capacity in ambulatory children with CP. Aim #2. Examine the effects of treatment on community-based walking activity performance and mobility. Aim #3. Explore whether the effects of SBLTT on walking capacity and performance are mediated by muscle power generation. The proposed research will be the first step in a continuum of research that is expected to direct locomotor training protocols and rehab strategies across pediatric disabilities and positively effecting the community walking performance and mobility for children with CP. | ||||||||
| Detailed Description | In a randomized clinical trial, 72 ambulatory children with spastic CP (6-10 yrs.) will receive either SBLTT or an equivalent dosage of TLTT for 40 sessions, 5x/week for 8 weeks in a massed practice format. The only difference between training protocols will be the variable training (interval fast versus steady state walking speeds). Thus, the key ingredient will be the intensity of the interval training delivered in a serial blocked practice schedule. Outcomes will be collected at baseline, 4 and 8 weeks to assess dosage, and 24 weeks post training for long term retention with the primary endpoint at 8 weeks. | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Participants are randomized to either short-burst interval locomotor treadmill training (SBLTT) or traditional locomotor treadmill training (TLTT) Masking: Single (Outcomes Assessor)Primary Purpose: Treatment |
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| Condition ICMJE | Cerebral Palsy | ||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
72 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | January 31, 2025 | ||||||||
| Estimated Primary Completion Date | January 31, 2024 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 6 Years to 10 Years (Child) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT04026295 | ||||||||
| Other Study ID Numbers ICMJE | R01HD098270( U.S. NIH Grant/Contract ) | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Kristie Bjornson, Seattle Children's Hospital | ||||||||
| Study Sponsor ICMJE | Kristie Bjornson | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | Seattle Children's Hospital | ||||||||
| Verification Date | June 2021 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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