Cerebral PalsyPT³NCT03625570
Power Training Combined With Interval Treadmill Training
A study testing Power training combined with interval treadmill training and Strength training combined with traditional treadmill training in people with Cerebral Palsy and Central Nervous System Diseases, run by Louisiana State University Health Sciences Center in New Orleans at 2 sites in United States.
Trial summary
Ambulatory children with cerebral palsy (CP) experience walking limitations which negatively influence their ability to physically participate in day to day life. The investigators propose that impaired muscle power generation is the key limiting factor affecting walking activity and participation. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Cerebral Palsy, Central Nervous System Diseases, Brain Damage, Chronic
- What is being tested?
- Power training combined with interval treadmill training and Strength training combined with traditional treadmill training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Apr 2019to 10 Nov 2023
- 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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of bilateral spastic Cerebral Palsy (CP)
- Age 10 to 17 years inclusive
- GMFCS levels I, II, or III
Who cannot join
- Orthopedic or neurosurgery less than 12 months prior to enrollment
- Injection therapies (phenol, botulinum toxin) less than 3 months prior to enrollment
- Lacking greater than 25 degrees of knee extension
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Louisiana State University Health Sciences Center
New Orleans, Louisiana, 70112
Seattle Children's Hospital
Seattle, Washington, 98121
About this study
Official title: Power Training Combined With Interval Treadmill Training to Improve Walking Activity in Cerebral Palsy (PT³)
Ambulatory children with cerebral palsy (CP) experience walking limitations which negatively influence their ability to physically participate in day to day life. The investigators propose that impaired muscle power generation is the key limiting factor affecting walking activity and participation. This proposal represents a combined approach where participants undergo resistance training for muscle power generation in combination with locomotor treadmill training that is based on typical pediatric walking and activity patterns rather than adult protocols, which are endurance or time-based. Therefore, the primary objective of this randomized controlled trial is to determine the effect of lower extremity Power Training combined with interval Treadmill Training (PT³) on functional walking capacity and community-based activity and participation in children with CP. We hypothesize that remediating the most pronounced muscle performance impairment (i.e., muscle power) with power training combined with a task- specific approach to walking that is developmentally appropriate will have a significant effect on walking capacity and performance.
Read the detailed description
The primary purpose of this randomized controlled trial is to test the effect of Power Training combined with interval Treadmill Training (PT³) on walking capacity and performance in children with CP with walking limitations. To identify key muscular mechanisms associated with improved walking mobility, the effects of PT³ on muscle performance and architecture will be examined. The premise of the PT³ protocol is that a combined impairment and task-specific approach that is developmentally appropriate and targets muscle power deficits specifically, is necessary to drive changes in both clinic and community-based walking activity.
In this randomized multi-site clinical trial, 48 ambulatory participants with CP will receive either PT³ or an equivalent dosage of traditional strength training combined with traditional treadmill training (comparison group) for 24 sessions, 3 times per week for 8 weeks. Outcomes will be collected at baseline and immediately post-treatment. Short and long-term retention effects will be assessed at 2 and 6 months post.
- Being tested
- Power training combined with interval treadmill training, Strength training combined with traditional treadmill training
- Keywords
- muscle weakness, muscle power, resistance training, treadmill training
- Medical subject headings
- Cerebral Palsy, Central Nervous System Diseases, Brain Damage, Chronic, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Power training combined with interval treadmill trainingBehavioural
Training will consist of unilateral and bilateral leg presses, targeting the quadriceps, hip extensors, and plantarflexors according to resistance training guidelines for muscle power training. The interval treadmill training portion will include short-bursts (30 seconds) of high speed walking intervals alternating with 30 seconds of low to moderate speed walking for a total of 30 minutes. Participants will train 3 x per week for 8 weeks. Total duration of each session will be approximately 1 hour.
Strength training combined with traditional treadmill trainingBehavioural
Training will consist of unilateral and bilateral leg presses, targeting the quadriceps, hip extensors, and plantarflexors following the dosing and resistance training guidelines for muscle strength. Traditional treadmill training will consist of walking at steady-state speeds for 30 minutes. Participants will train 3 x per week for 8 weeks. Total duration of each session will be approximately 1 hour.
| Study group | Role | What they receive |
|---|---|---|
| PT³ | Experimental | Power Training combined with interval treadmill training Receives: Behavioral: Power training combined with interval treadmill training |
| Traditional training | Active comparator | Strength training combined with traditional treadmill training Receives: Behavioral: Strength training combined with traditional treadmill training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Self-selected Gait Speed (Normalized)
Calculated from the 10 meter walk test in meters/second at self-selected speed and then normalized by stature to yield non-dimensional units. Higher values represent faster gait speeds.
Measured: Baseline and immediate post training (8-10 weeks post baseline)
Change in Fast Gait Speed (Normalized)
Calculated from the 10 meter walk test in meters/second at fast walking speed and then normalized by stature to yield non-dimensional units. Higher values equal faster gait speeds.
Measured: Baseline and immediate post training (8-10 weeks post baseline)
Change in Peak Power
Lower extremity peak power produced during a power leg press test averaged over 5 trials; product of force x velocity; adjusted for sled angle and body mass
Measured: Baseline and immediate post training (8-10 weeks post baseline)
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 and immediate post training (8-10 weeks post baseline)
Secondary outcomes (10)
Change in Self-selected Gait Speed (Normalized)
Calculated from the 10 meter walk test in meters/second at self-selected speed and then normalized by stature to yield non-dimensional units. Higher values equal faster speeds.
Measured: Baseline and 2 months post training (16 weeks post baseline)
Change in Fast Gait Speed (Normalized)
Calculated from the 10 meter walk test in meters/second at fast walking speed and then normalized by stature to yield non-dimensional units. Higher values equal faster speeds.
Measured: Baseline and 2 months post training (16 weeks post baseline)
Change in Peak Power
Lower extremity peak power produced during a power leg press test averaged over 5 trials; product of force x velocity; adjusted for sled angle and body mass
Measured: Baseline and 2 months post training (16 weeks post baseline)
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 and 2 months post training (16 weeks post baseline)
Change in One Minute Walk Test
Distance covered while walking as fast as possible for 1 minute measured in meters
Measured: Baseline and immediate post training (8-10 weeks post baseline)
Change in Cross-sectional Area
Cross-sectional area of rectus femoris taken at 50% distance between anterior superior iliac spine and apex of patella using 2D Bmode Ultrasound imaging in cm^2; Average of Right and Left Sides
Measured: Baseline and immediate post training (8-10 weeks post baseline)
Change in Isokinetic Muscle Strength of Knee Extensors
Isokinetic dynamometer (Biodex System 3/4) according to published standard procedures for isokinetic strength. Calculated for knee extensors at 60 degrees/second in newton-meters
Measured: Baseline and immediate post training (8-10 weeks post baseline)
Change in Walking Intensity at Medium and High Stride Rates (Strides/Minute)
Average strides/day at medium (31 to 60 stride/min) and high (> 60 stride/min) stride rates as captured by Step Watch accelerometer as worn for a minimum of 4 days
Measured: Baseline and immediate post training (8-10 weeks post baseline)
Change in Patient-Reported Outcomes Measurement Information System Physical Function-Mobility (PROMIS v2.0 Pediatric Profile 49 - Physical Function-Mobility)
Patient-Reported Outcomes Measurement Information System (PROMIS); The PROMIS item bank was developed from patient-reported outcome measures that indicate patients' state of well-being and functional abilities. The results of the Physical Function-Mobility domain are reported here as the Change in the T-score from baseline to 8-10wks post baseline. The T-score is a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean. A higher PROMIS T-score represents more of the concept being measured so for a positive concept, such as Physical Function-Mobility, a higher T-score or 'change' in the T-score represents higher physical functioning and mobility.
Measured: Baseline and immediate post training (8-10 weeks post baseline)
Change in 1RM (Muscle Strength)
1repetition maximum (1RM) testing on a leg press reported in lbs; external load reported after adjusting for the angle of the press
Measured: Baseline and immediate post training (8-10 weeks post baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start15 Apr 2019
- Primary completion4 Oct 2023
- Study completion10 Nov 2023
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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center in New Orleans
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Washington
- Responsible party
- Sponsor
- Investigators
- Noelle G Moreau, PT, PhD, Principal investigator, Louisiana State University Health Sciences Center in New Orleans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03625570
- Sponsor's protocol ID
- R01HD091089
- Other IDs
- R01HD091089
- Acronym
- PT³
- Status last verified
- Nov 2024
- First submitted
- 1 Aug 2018
- Last updated
- 13 Dec 2024
- 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 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Power Training Combined With Interval Treadmill Training to Improve Walking Activity in Cerebral Palsy (PT³)
- ClinicalTrials.gov ID
- NCT03625570
- Acronym / sponsor ID
- PT³ / R01HD091089
- Keywords
- muscle weakness, muscle power, resistance training, treadmill training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Louisiana State University Health Sciences Center in New OrleansUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Washington
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 4 Oct 2023 (actual)
- Study completion
- 10 Nov 2023 (actual)
- First posted
- 10 Aug 2018 (actual)
- Results
- Posted 13 Dec 2024
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) experience walking limitations which negatively influence their ability to physically participate in day to day life. The investigators propose that impaired muscle power generation is the key limiting factor affecting walking activity and participation. This proposal represents a combined approach where participants undergo resistance training for muscle power generation in combination with locomotor treadmill training that is based on typical pediatric walking and activity patterns rather than adult protocols, which are endurance or time-based. Therefore, the primary objective of this randomized controlled trial is to determine the effect of lower extremity Power Training combined with interval Treadmill Training (PT³) on functional walking capacity and community-based activity and participation in children with CP. We hypothesize that remediating the most pronounced muscle performance impairment (i.e., muscle power) with power training combined with a task- specific approach to walking that is developmentally appropriate will have a significant effect on walking capacity and performance.
Detailed description
The primary purpose of this randomized controlled trial is to test the effect of Power Training combined with interval Treadmill Training (PT³) on walking capacity and performance in children with CP with walking limitations. To identify key muscular mechanisms associated with improved walking mobility, the effects of PT³ on muscle performance and architecture will be examined. The premise of the PT³ protocol is that a combined impairment and task-specific approach that is developmentally appropriate and targets muscle power deficits specifically, is necessary to drive changes in both clinic and community-based walking activity.
In this randomized multi-site clinical trial, 48 ambulatory participants with CP will receive either PT³ or an equivalent dosage of traditional strength training combined with traditional treadmill training (comparison group) for 24 sessions, 3 times per week for 8 weeks. Outcomes will be collected at baseline and immediately post-treatment. Short and long-term retention effects will be assessed at 2 and 6 months post.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PT³ | Experimental | Behavioral: Power training combined with interval treadmill trainingPower Training combined with interval treadmill training |
| Traditional training | Active comparator | Behavioral: Strength training combined with traditional treadmill trainingStrength training combined with traditional treadmill training |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Diagnosis of bilateral spastic Cerebral Palsy (CP)
- Age 10 to 17 years inclusive
- GMFCS levels I, II, or III
Key exclusion criteria (3 listed)
- Orthopedic or neurosurgery less than 12 months prior to enrollment
- Injection therapies (phenol, botulinum toxin) less than 3 months prior to enrollment
- Lacking greater than 25 degrees of knee extension
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 |
|---|---|---|
| Power training combined with interval treadmill trainingTraining will consist of unilateral and bilateral leg presses, targeting the quadriceps, hip extensors, and plantarflexors according to resistance training guidelines for muscle power training. The interval treadmill training portion will include short-bursts (30 seconds) of high speed walking intervals alternating with 30 seconds of low to moderate speed walking for a total of 30 minutes. Participants will train 3 x per week for 8 weeks. Total duration of each session will be approximately 1 hour. | Behavioural | PT³ |
| Strength training combined with traditional treadmill trainingTraining will consist of unilateral and bilateral leg presses, targeting the quadriceps, hip extensors, and plantarflexors following the dosing and resistance training guidelines for muscle strength. Traditional treadmill training will consist of walking at steady-state speeds for 30 minutes. Participants will train 3 x per week for 8 weeks. Total duration of each session will be approximately 1 hour. | Behavioural | Traditional training |
Primary outcome
Change in Self-selected Gait Speed (Normalized)
Time frame: Baseline and immediate post training (8-10 weeks post baseline)
Calculated from the 10 meter walk test in meters/second at self-selected speed and then normalized by stature to yield non-dimensional units. Higher values represent faster gait speeds.
Change in Fast Gait Speed (Normalized)
Time frame: Baseline and immediate post training (8-10 weeks post baseline)
Calculated from the 10 meter walk test in meters/second at fast walking speed and then normalized by stature to yield non-dimensional units. Higher values equal faster gait speeds.
Change in Peak Power
Time frame: Baseline and immediate post training (8-10 weeks post baseline)
Lower extremity peak power produced during a power leg press test averaged over 5 trials; product of force x velocity; adjusted for sled angle and body mass
Change in Average Strides Per Day
Time frame: Baseline and immediate post training (8-10 weeks post baseline)
Average number of strides walked per day captured by Step Watch accelerometer as worn for a minimum of 4 days
10 secondary outcomes
Change in Self-selected Gait Speed (Normalized)
Time frame: Baseline and 2 months post training (16 weeks post baseline)
Change in Fast Gait Speed (Normalized)
Time frame: Baseline and 2 months post training (16 weeks post baseline)
Change in Peak Power
Time frame: Baseline and 2 months post training (16 weeks post baseline)
Change in Average Strides Per Day
Time frame: Baseline and 2 months post training (16 weeks post baseline)
Change in One Minute Walk Test
Time frame: Baseline and immediate post training (8-10 weeks post baseline)
Change in Cross-sectional Area
Time frame: Baseline and immediate post training (8-10 weeks post baseline)
Change in Isokinetic Muscle Strength of Knee Extensors
Time frame: Baseline and immediate post training (8-10 weeks post baseline)
Change in Walking Intensity at Medium and High Stride Rates (Strides/Minute)
Time frame: Baseline and immediate post training (8-10 weeks post baseline)
Change in Patient-Reported Outcomes Measurement Information System Physical Function-Mobility (PROMIS v2.0 Pediatric Profile 49 - Physical Function-Mobility)
Time frame: Baseline and immediate post training (8-10 weeks post baseline)
Change in 1RM (Muscle Strength)
Time frame: Baseline and immediate post training (8-10 weeks post baseline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- 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.
Noelle G Moreau, PT, PhD principal investigator
Louisiana State University Health Sciences Center 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 Power training combined with interval treadmill training and Strength training combined with traditional treadmill training in people with Cerebral Palsy and Central Nervous System Diseases, run by Louisiana State University Health Sciences Center in New Orleans 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 3 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 13 Dec 2024. 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 13 Dec 2024). 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 Self-selected Gait Speed (Normalized) (time frame: Baseline and immediate post training (8-10 weeks post baseline)). The study lists 4 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 13 Dec 2024.