Cerebral Palsy Spastic DiplegiaNCT03373890
Cerebral Palsy: Short-burst Interval Training
A study testing Short Burst Interval Locomotor Treadmill Training (SBLTT) in people with Cerebral Palsy Spastic Diplegia, run by Seattle Children's Hospital at 1 site in United States.
Trial summary
This study examines the effect of short burst interval treadmill training in ambulatory children with cerebral palsy. Half the sample will receive 20 sessions of training over 4 weeks, while half will receive the training over 10 weeks. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Cerebral Palsy Spastic Diplegia
- What is being tested?
- Short Burst Interval Locomotor Treadmill Training (SBLTT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2014to 31 Jul 2016
- 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Ambulatory children with cerebral palsy Spasticity primary movement disorder Bilateral motor impairment (Diplegia) Gross Motor Function Classification System Levels II and III
Who cannot join
- undergone orthopedic or neurosurgery less than 12 months prior injection therapies (phenol, botulinum toxin) less than 3 months prior
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Children's Research Institute
Seattle, Washington, 98115
About this study
Official title: Muscle Performance and Walking in Cerebral Palsy: Short-burst Interval Training
This study examines the effect of short burst interval treadmill training in ambulatory children with cerebral palsy. Half the sample will receive 20 sessions of training over 4 weeks, while half will receive the training over 10 weeks.
Read the detailed description
Ambulatory children with cerebral palsy (CP) experience activity limitations which negatively influence their ability to physically participate in day to day life. Therefore, these children are at greater risk for inactivity and functional decline with age. In contrast, typically developing (TD) children engage in short bursts of intense physical activity interspersed with varying intervals of low and moderate intensity within their natural environment. These physical activity patterns are very different from adult patterns Despite these inherent differences, locomotor treadmill training (LTT) protocols designed to improve walking activity in children with CP simulate adult protocols, consisting of continuous low to moderate walking endurance activity. Body weight supported or robot assisted LTT is based on the underlying premise of modifying neural circuitry via spinal pathways. However, this type of training has not been shown to be more effective than other comparable interventions and presents with significant fiscal and logistical barriers to clinical translation.
This study will determine the effect of short-burst interval LTT without body weight support on the primary outcomes of walking performance and capacity and the secondary outcomes of day-to-day mobility based participation in children with CP with functional walking limitations. To identify key muscular mechanisms associated with improved walking mobility, the investigators will examine the effects of short-burst interval LTT on quadriceps muscle performance and architecture. Secondarily, the study team will collect preliminary data on two LTT dosing frequencies.
- Conditions
- Cerebral Palsy Spastic Diplegia
- Being tested
- Short Burst Interval Locomotor Treadmill Training (SBLTT)
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short Burst Interval Locomotor Treadmill Training (SBLTT)Behavioural
SBLTT consists of interval training consisting of short-bursts (30 seconds) of vigorous intensity locomotor treadmill training (LTT) alternating with low to moderate intensity LTT.,
| Study group | Role | What they receive |
|---|---|---|
| Short burst Interval Treadmill Training High Frequency | Experimental | Participants receive short burst interval treadmill training for a total of 20 sessions. They are randomized to receive it either 5x/week for 4 weeks Receives: Behavioral: Short Burst Interval Locomotor Treadmill Training (SBLTT) |
| Short Burst Interval Treadmill Training Low Frequency | Active comparator | Participants receive short burst interval treadmill training for a total of 20 sessions. They are randomized to receive it either 2x/week for 10 weeks Receives: Behavioral: Short Burst Interval Locomotor Treadmill Training (SBLTT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Walking Performance High Versus Low Frequency SBLTT Groups
Average stride per day as measured by StepWatch accelerometry. StepWatch accelerometer stride counts per day ( minimum of 8 hrs/day wearing time) were averaged a crossed 5 days (4 weekdays and 1 weekend day) to create Average Strides/day variable
Measured: Change from baseline to immediately post SBLTT
Change in Community Walking Performance Intensity High Versus Low Frequency SBLTT Groups
Average Strides/day > 30 strides/min as measured by StepWatch accelerometry High Versus Low Frequency SBLTT Groups
Measured: Change from baseline to immediately post SBLTT
Change in Walking Capacity High Versus Low Frequency SBLTT Groups
Self selected walking speed as measured by 10 meter walk test High Versus Low Frequency SBLTT Groups
Measured: Change from baseline to immediately post SBLT.
Change in Walking Endurance- High Versus Low Frequency SBLTT Groups
Distance walked during the One Minute Walk Test High Versus Low Frequency SBLTT Groups
Measured: Change from baseline to immediately post SBLTT
Secondary outcomes (4)
Change in Muscle Performance -Power High Versus Low Frequency SBLTT Groups
Knee extensor muscle power - isotonic muscle power as measured by Biodex testing High Versus Low Frequency SBLTT Groups
Measured: Change from baseline to 6 weeks post SBLTT
Change in Muscle Performance - Strength High Versus Low Frequency SBLTT Groups
Knee extensor muscle strength - isometric muscle strength as measured by Biodex testing High Versus Low Frequency SBLTT Groups
Measured: Change from baseline to immediately post SBLTT
Change in Muscle Architecture-High Versus Low Frequency SBLTT Groups
Rectus femoris mid thigh cross-sectional area as measured by 2D B Mode Ultrasound High Versus Low Frequency SBLTT Groups
Measured: Change from baseline to immediately post SBLTT
Change in Muscle Architecture-hypertrophy High Versus Low Frequency SBLTT Groups
Rectus femoris mid thigh fascicle length as measured by 2D B Mode Ultrasound High Versus Low Frequency SBLTT Groups
Measured: Change from baseline to immediately post SBLTT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2017
- Study start1 Aug 2014
- Primary completion31 Jul 2016
- Study completion31 Jul 2016
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 Palsy Spastic DiplegiaStudies 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
- Pre/post intervention design with participants randomized to two different frequency of intervention
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Louisiana State University Health Sciences Center in New Orleans
- Responsible party
- Principal investigator, Kristie Bjornson, Seattle Children's Hospital
- Investigators
- James Hendricks, PhD, Study director, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03373890
- Sponsor's protocol ID
- R21HD077186
- Status last verified
- Jun 2019
- First submitted
- 6 Dec 2017
- Last updated
- 10 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Performance and Walking in Cerebral Palsy: Short-burst Interval Training
- ClinicalTrials.gov ID
- NCT03373890
- Acronym / sponsor ID
- R21HD077186
- Conditions
- Cerebral Palsy Spastic Diplegia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- Louisiana State University Health Sciences Center in New Orleans
- Study start
- 1 Aug 2014 (actual)
- Primary completion
- 31 Jul 2016 (actual)
- Study completion
- 31 Jul 2016 (actual)
- First posted
- 14 Dec 2017 (actual)
- Results
- Posted 10 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines the effect of short burst interval treadmill training in ambulatory children with cerebral palsy. Half the sample will receive 20 sessions of training over 4 weeks, while half will receive the training over 10 weeks.
Detailed description
Ambulatory children with cerebral palsy (CP) experience activity limitations which negatively influence their ability to physically participate in day to day life. Therefore, these children are at greater risk for inactivity and functional decline with age. In contrast, typically developing (TD) children engage in short bursts of intense physical activity interspersed with varying intervals of low and moderate intensity within their natural environment. These physical activity patterns are very different from adult patterns Despite these inherent differences, locomotor treadmill training (LTT) protocols designed to improve walking activity in children with CP simulate adult protocols, consisting of continuous low to moderate walking endurance activity. Body weight supported or robot assisted LTT is based on the underlying premise of modifying neural circuitry via spinal pathways. However, this type of training has not been shown to be more effective than other comparable interventions and presents with significant fiscal and logistical barriers to clinical translation.
This study will determine the effect of short-burst interval LTT without body weight support on the primary outcomes of walking performance and capacity and the secondary outcomes of day-to-day mobility based participation in children with CP with functional walking limitations. To identify key muscular mechanisms associated with improved walking mobility, the investigators will examine the effects of short-burst interval LTT on quadriceps muscle performance and architecture. Secondarily, the study team will collect preliminary data on two LTT dosing frequencies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Pre/post intervention design with participants randomized to two different frequency of intervention
| Arm | Type | Receives |
|---|---|---|
| Short burst Interval Treadmill Training High Frequency | Experimental | Behavioral: Short Burst Interval Locomotor Treadmill Training (SBLTT)Participants receive short burst interval treadmill training for a total of 20 sessions. They are randomized to receive it either 5x/week for 4 weeks |
| Short Burst Interval Treadmill Training Low Frequency | Active comparator | Behavioral: Short Burst Interval Locomotor Treadmill Training (SBLTT)Participants receive short burst interval treadmill training for a total of 20 sessions. They are randomized to receive it either 2x/week for 10 weeks |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Ambulatory children with cerebral palsy Spasticity primary movement disorder Bilateral motor impairment (Diplegia) Gross Motor Function Classification System Levels II and III
Key exclusion criteria (1 listed)
- undergone orthopedic or neurosurgery less than 12 months prior injection therapies (phenol, botulinum toxin) less than 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 Locomotor Treadmill Training (SBLTT)SBLTT consists of interval training consisting of short-bursts (30 seconds) of vigorous intensity locomotor treadmill training (LTT) alternating with low to moderate intensity LTT., | Behavioural | Short Burst Interval Treadmill Training Low Frequency, Short burst Interval Treadmill Training High Frequency |
Primary outcome
Change in Walking Performance High Versus Low Frequency SBLTT Groups
Time frame: Change from baseline to immediately post SBLTT
Average stride per day as measured by StepWatch accelerometry. StepWatch accelerometer stride counts per day ( minimum of 8 hrs/day wearing time) were averaged a crossed 5 days (4 weekdays and 1 weekend day) to create Average Strides/day variable
Change in Community Walking Performance Intensity High Versus Low Frequency SBLTT Groups
Time frame: Change from baseline to immediately post SBLTT
Average Strides/day > 30 strides/min as measured by StepWatch accelerometry High Versus Low Frequency SBLTT Groups
Change in Walking Capacity High Versus Low Frequency SBLTT Groups
Time frame: Change from baseline to immediately post SBLT.
Self selected walking speed as measured by 10 meter walk test High Versus Low Frequency SBLTT Groups
Change in Walking Endurance- High Versus Low Frequency SBLTT Groups
Time frame: Change from baseline to immediately post SBLTT
Distance walked during the One Minute Walk Test High Versus Low Frequency SBLTT Groups
4 secondary outcomes
Change in Muscle Performance -Power High Versus Low Frequency SBLTT Groups
Time frame: Change from baseline to 6 weeks post SBLTT
Change in Muscle Performance - Strength High Versus Low Frequency SBLTT Groups
Time frame: Change from baseline to immediately post SBLTT
Change in Muscle Architecture-High Versus Low Frequency SBLTT Groups
Time frame: Change from baseline to immediately post SBLTT
Change in Muscle Architecture-hypertrophy High Versus Low Frequency SBLTT Groups
Time frame: Change from baseline to immediately post SBLTT
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
- 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.
James Hendricks, PhD study director
Seattle Children's Hospital
1 site 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 Locomotor Treadmill Training (SBLTT) in people with Cerebral Palsy Spastic Diplegia, run by Seattle Children's Hospital 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 1 inclusion and 1 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 10 Jul 2019. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jul 2019). 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 Performance High Versus Low Frequency SBLTT Groups (time frame: Change from baseline to immediately post SBLTT). 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 10 Jul 2019.