Cerebral PalsyNCT04026295
Short-Burst Interval Treadmill Training Cerebral Palsy
A study testing Short Burst Interval Treadmill Training (SBLTT) and Traditional Locomotor Treadmill Training (TLTT) in people with Cerebral Palsy, run by Kristie Bjornson at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Short Burst Interval Treadmill Training (SBLTT) and Traditional Locomotor Treadmill Training (TLTT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Nov 2019to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Bilateral and unilateral spastic cerebral palsy
- Gross Motor Function Classification Levels II \& III
- Ages 6 years to < 11 years
Who cannot join
- Orthopedic or neurosurgery < 9 months prior
- Injection therapy (Botulinum Toxin/Phenol) < 3 months prior
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lousianna State University Health Sciences Center New Orleans
New Orleans, Louisiana, 70112
Seattle Childrens Research Institute
Seattle, Washington, 98121
About this study
Official title: Short-Burst Interval Treadmill Training to Improve Community Walking Activity and Mobility in Cerebral Palsy
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.
Read the 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.
- Conditions
- Cerebral Palsy
- Being tested
- Short Burst Interval Treadmill Training (SBLTT), Traditional Locomotor Treadmill Training (TLTT)
- Keywords
- treadmill training, gait, short burst interval locomotor training, spastic
- Medical subject headings
- Cerebral Palsy, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short Burst Interval Treadmill Training (SBLTT)Behavioural
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.
Traditional Locomotor Treadmill Training (TLTT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Short burst Interval Treadmill Training (SBLTT) | Experimental | 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 Receives: Behavioral: Short Burst Interval Treadmill Training (SBLTT) |
| Traditional Locomotor Treadmill Training (TLTT) | Active comparator | TLTT will consist of walking at steady-state speeds. Participant will receive 40 home-based sessions (5x/week for 8 weeks) of TLTT Receives: Behavioral: Traditional Locomotor Treadmill Training (TLTT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Walking Capacity-Self-selected Walking Speed (Normalized)
Normalized 10 Meter Walk Test in meters/second. Calculated from the 10-meter walk test in meters/second at self-selected speed and then normalized by the following formula: velocity / square root (9.81 x leg length) yielding non-dimensional units. Higher values represent faster gait speeds.
Measured: Baseline to 8 weeks
Change in Walking Capacity-Fast Walking Speed (Normalized)
Calculated from the 10-meter walk test in meters/second at fast walking speed and then normalized by the following formula: velocity / square root (9.81 x leg length) yielding non-dimensional units. Higher values represent faster gait speeds.
Measured: Baseline to 8 weeks
Change in One Minute Walk Test
Distance covered while walking as fast as possible for 1 minute measured in meters
Measured: Baseline to 8 weeks
Change in Average Strides Per Day
Average number of strides walked per day captured by Step Watch accelerometer as worn for a minimum of 4 days.
Measured: Baseline to 8 weeks
Absolute Change in Percent Strides/Day in Medium/High Stride Rates
StepWatch (SW) accelerometry - percent of strides/day in medium/high stride rates (> 30 strides/minute). Calculated as percentage value at 8 weeks minus the percentage value at baseline.
Measured: Baseline to 8 weeks
Change in Right Knee Extensor Muscle Power
Isokinetic dynamometer (Biodex System 3/4) according to published standard procedures for isokinetic power. Calculated for right knee extensors at 60 degrees/second in watts.
Measured: Baseline to 8 weeks.
Change in Left Knee Extensor Muscle Power
Isokinetic dynamometer (Biodex System 3/4) according to published standard procedures for isokinetic power. Calculated for left knee extensors at 60 degrees/second in watts.
Measured: Baseline to 8 weeks
Secondary outcomes (8)
Change in Average Strides Per Day in the Home.
StepWatch (SW) accelerometry strides/day synchronized with Global Positioning System (GPS) home location setting- average strides per day.
Measured: Baseline to 8 weeks
Absolute Change in Percent Average Strides/Day in the Community.
StepWatch (SW) accelerometry synchronized with Global Positioning System (GPS) home setting- percent average strides/day in the community. Calculated as percentage value at 8 weeks minus the percentage value at baseline.
Measured: Baseline to 8 weeks
Change in PROMIS Physical Function Domain Score -
Patient-Reported Outcomes Measurement Information System (PROMIS v1.0 Parent Pediatric Profile) physical function domain score T scores, Mean of 50 and standard deviation of 10. Higher is a better report of physical function.
Measured: Baseline to 8 weeks
Change in Gait Outcomes Assessment List (GOAL) Total Score
Parent report Gait Outcome Assessment List (GOAL).total score scale 0-10 with higher score better parent report of gait walking skills and mobility.
Measured: Baseline to 8 weeks
Change in Right Knee Peak Extensor Muscle Torque (Normalized).
Isokinetic Peak Torque for right knee extensors at 60 deg/s as measured by Biodex normalized by kg/weight.
Measured: Baseline to 8 weeks.
Absolute Change in Percent Average Strides/Day in Medium/High Activity in the Home.
StepWatch (SW) accelerometry synchronized (average strides/day) with Global Positioning System (GPS) home setting- percent average strides/day in medium/high stride rates (>30 strides/minute). Calculated as percentage value at 8 weeks minus the percentage value at baseline.
Measured: Baseline to 8 weeks
Absolute Change in Percent Average Strides/Day at Medium/High Stride Rates in the Community
StepWatch (SW) accelerometry synchronized with Global Positioning System (GPS) community setting- percent average strides/day at medium/high stride rates (>30 strides/minute). Calculated as percentage value at 8 weeks minus the percentage value at baseline.
Measured: Baseline to 8 weeks
Change in Left Knee Peak Extensor Muscle Torque (Normalized).
Isokinetic Peak Torque for Left knee extensors at 60 deg/s as measured by Biodex normalized by kg/weight.
Measured: Baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start27 Nov 2019
- Primary completion1 Aug 2025
- Study completion31 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized to either short-burst interval locomotor treadmill training (SBLTT) or traditional locomotor treadmill training (TLTT)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kristie Bjornson
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, Louisiana State University Health Sciences Center in New Orleans
- Responsible party
- Sponsor-investigator, Kristie Bjornson, Seattle Children's Hospital
- Investigators
- Kristie F Bjornson, PhD, PT, Principal investigator, Seattle Children's HospitalNoelle Moreau, PhD, PT, Principal investigator, Lousianna State University in New Orleans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04026295
- Sponsor's protocol ID
- R01HD098270
- Status last verified
- Oct 2026
- First submitted
- 17 Jul 2019
- Last updated
- 29 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Burst Interval Treadmill Training to Improve Community Walking Activity and Mobility in Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04026295
- Acronym / sponsor ID
- R01HD098270
- Conditions
- Cerebral Palsy
- Keywords
- treadmill training, gait, short burst interval locomotor training, spastic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kristie BjornsonUniversity, hospital or other
- Collaborators
- University of Washington, Louisiana State University Health Sciences Center in New Orleans
- Study start
- 27 Nov 2019 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 19 Jul 2019 (actual)
- Results
- Posted 29 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomized to either short-burst interval locomotor treadmill training (SBLTT) or traditional locomotor treadmill training (TLTT)
| Arm | Type | Receives |
|---|---|---|
| Short burst Interval Treadmill Training (SBLTT) | Experimental | 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. Participant will receive 40 home-based sessions (5x/week for 8 weeks) of SBLTT |
| Traditional Locomotor Treadmill Training (TLTT) | Active comparator | Behavioral: 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 |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Bilateral and unilateral spastic cerebral palsy
- Gross Motor Function Classification Levels II \& III
- Ages 6 years to < 11 years
Key exclusion criteria (2 listed)
- Orthopedic or neurosurgery < 9 months prior
- Injection therapy (Botulinum Toxin/Phenol) < 3 months prior
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 |
|---|---|---|
| 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. | Behavioural | Short burst Interval Treadmill Training (SBLTT) |
| 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. | Behavioural | Traditional Locomotor Treadmill Training (TLTT) |
Primary outcome
Change in Walking Capacity-Self-selected Walking Speed (Normalized)
Time frame: Baseline to 8 weeks
Normalized 10 Meter Walk Test in meters/second. Calculated from the 10-meter walk test in meters/second at self-selected speed and then normalized by the following formula: velocity / square root (9.81 x leg length) yielding non-dimensional units. Higher values represent faster gait speeds.
Change in Walking Capacity-Fast Walking Speed (Normalized)
Time frame: Baseline to 8 weeks
Calculated from the 10-meter walk test in meters/second at fast walking speed and then normalized by the following formula: velocity / square root (9.81 x leg length) yielding non-dimensional units. Higher values represent faster gait speeds.
Change in One Minute Walk Test
Time frame: Baseline to 8 weeks
Distance covered while walking as fast as possible for 1 minute measured in meters
Change in Average Strides Per Day
Time frame: Baseline to 8 weeks
Average number of strides walked per day captured by Step Watch accelerometer as worn for a minimum of 4 days.
Absolute Change in Percent Strides/Day in Medium/High Stride Rates
Time frame: Baseline to 8 weeks
StepWatch (SW) accelerometry - percent of strides/day in medium/high stride rates (> 30 strides/minute). Calculated as percentage value at 8 weeks minus the percentage value at baseline.
Change in Right Knee Extensor Muscle Power
Time frame: Baseline to 8 weeks.
Isokinetic dynamometer (Biodex System 3/4) according to published standard procedures for isokinetic power. Calculated for right knee extensors at 60 degrees/second in watts.
Change in Left Knee Extensor Muscle Power
Time frame: Baseline to 8 weeks
Isokinetic dynamometer (Biodex System 3/4) according to published standard procedures for isokinetic power. Calculated for left knee extensors at 60 degrees/second in watts.
8 secondary outcomes
Change in Average Strides Per Day in the Home.
Time frame: Baseline to 8 weeks
Absolute Change in Percent Average Strides/Day in the Community.
Time frame: Baseline to 8 weeks
Change in PROMIS Physical Function Domain Score -
Time frame: Baseline to 8 weeks
Change in Gait Outcomes Assessment List (GOAL) Total Score
Time frame: Baseline to 8 weeks
Change in Right Knee Peak Extensor Muscle Torque (Normalized).
Time frame: Baseline to 8 weeks.
Absolute Change in Percent Average Strides/Day in Medium/High Activity in the Home.
Time frame: Baseline to 8 weeks
Absolute Change in Percent Average Strides/Day at Medium/High Stride Rates in the Community
Time frame: Baseline to 8 weeks
Change in Left Knee Peak Extensor Muscle Torque (Normalized).
Time frame: Baseline to 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Kristie F Bjornson, PhD, PT principal investigator
Seattle Children's Hospital
Noelle Moreau, PhD, PT principal investigator
Lousianna State University in New Orleans
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short Burst Interval Treadmill Training (SBLTT) and Traditional Locomotor Treadmill Training (TLTT) in people with Cerebral Palsy, run by Kristie Bjornson at 2 sites 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 3 inclusion and 2 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 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Capacity-Self-selected Walking Speed (Normalized) (time frame: Baseline to 8 weeks). The study lists 7 primary outcomes in all. 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 29 Oct 2026.