Cerebral PalsyNCT02424526
Intensive Home-based Treadmill Training and Walking Attainment in Young Children With Cerebral Palsy
A study testing home-based treadmill training and Treadmill in people with Cerebral Palsy, run by California State University, Sacramento at 2 sites in United States.
Trial summary
This study is designed to find the optimal dosage of home-based treadmill training needed to accelerate walking onset and to examine the long-term effects on the child's walking activity. Read more about this study
- Who is it for?
- Ages 1 year to 3 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- home-based treadmill training and Treadmill
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2015to Sep 2018
- 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 1 year to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Signs of walking readiness as demonstrated by the ability to sit for 30 seconds when placed and to take 5 to 7 steps when supported at the trunk or arms.
- Because young children often are not formally diagnosed with CP until 2 years of age, we will include children
- who show bilateral impairment (i.e. diplegia and quadriplegia, but not hemiplegia)
- who demonstrate upper motor neuron signs (i.e. spasticity and/or hyperreflexia)
- who have been identified as high-risk for a motor disability by a physician
Who cannot join
- a history of uncontrolled seizures
- a diagnosis of a genetic disorder
- cardiac or orthopedic contraindications for standing and walking
- orthopedic surgery in the past 6 months
- use of spasticity-reducing medication or Botox injections in the past 6 months
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Seattle Children's Research Institute
Seattle, Washington, 98145
University of the Puget Sound
Tacoma, Washington, 98416
About this study
This study is designed to find the optimal dosage of home-based treadmill training needed to accelerate walking onset and to examine the long-term effects on the child's walking activity.
Read the detailed description
The purpose of this study is to determine optimal parameters for dosing home-based treadmill training by comparing high-intensity (5 days/week, twice daily for 10-20 min for 6 weeks) to low-intensity (2 days/week, once daily for 10-20 minutes for 6 weeks) treadmill training; and to compare the effects of high- versus low-intensity treadmill training on walking attainment and overall walking activity in young children with cerebral palsy.
Hypotheses
- A more intensive protocol of treadmill training will increase walking onset in young children with CP.
- A more intensive protocol of treadmill training will increase overall walking activity in young children with CP.
Specific Aims
- To determine optimal parameters for dosing home-based treadmill training by comparing high-intensity to low-intensity home-based treadmill training.
- To compare the effects of high- versus low-intensity treadmill training on walking onset and overall walking activity.
Study design •Prospective randomized controlled trial
Study population
•Two groups of 12 children with CP under the age of 3 years and are not walking yet will receive either home-based high-intensity treadmill training or low-intensity treadmill training. The children will be assessed before, immediately after, at 1-month and at 4-months following the intervention via standardized outcome measures.
- Conditions
- Cerebral Palsy
- Being tested
- home-based treadmill training, Treadmill
- Keywords
- cerebral palsy, treadmill training, walking
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
home-based treadmill trainingOther
the child will walk on a pediatric treadmill with the help of the parent/caregiver and with weekly supervision of a physical therapist
TreadmillDevice
| Study group | Role | What they receive |
|---|---|---|
| high-intensity group | Active comparator | Children will engage in home-based treadmill training 5 days/week, twice daily for 10-20 min for 6 weeks Receives: Other: home-based treadmill training; Device: Treadmill |
| low-intensity group | Active comparator | Children will engage in home-based treadmill training 2 days/week, once daily for 10-20 minutes for 6 weeks Receives: Other: home-based treadmill training; Device: Treadmill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Motor Function Measure Dimension E
The Gross Motor Function Measure is a criterion-referenced test of gross motor function for children with cerebral palsy ages 5 months to 15 years. It contains 5 Dimensions (A-E). Dimension E is related to the child's gross motor skills related to walking, running and jumping and is assessed by observation. Dimension E contains 24 gross motor skills. Each of these motor skills is rated either 0 (does not initiate), 1(initiates), 2 (partially completes), 3 (completes) or NT( not tested). The total possible Dimension E score is 72 with a range of 0-72. Scores can be converted into a percent score by dividing the child's achieved points by the number of possible points. Higher scores and a higher percentage indicate better performance in walking, running and jumping. Change from baseline in total points, not in percentage, is reported.
Measured: assessed at 6 weeks, 1 month, 4 months from baseline
Walking Activity Measured by StepWatch
StepWatch data records the child's walking activity in minutes/day. It is collected via an accelerometer attached to the distal leg and worn at all waking hours except during sleep and bath time.Higher numbers of active minutes indicate higher level of activity. Changes from baseline are reported.
Measured: StepWatch data was collected for all awake daytime hours over a 7 day period at study onset before treadmill training commences and at 6 weeks, 1 month, 4 months.
Gross Motor Function Measure Dimension D
The Gross Motor Function Measure is a criterion-referenced test of gross motor function for children with cerebral palsy ages 5 months to 15 years. It contains 5 Dimensions (A-E).Dimension D is a test of gross motor function related to standing ability. The child's gross motor skills related to standing are assessed by observation. The test contains 13 gross motor skills. Each of these motor skills is rated either 0 (does not initiate), 1(initiates), 2 (partially completes), 3 (completes) or NT( not tested). The total possible Dimension D score is 39 with a range of 0-39. Scores can be converted into a percent score by dividing the child's achieved points by the number of possible points. Higher scores and a higher percentage indicate better performance in standing. Change from baseline in total points, not in percentage, is reported.
Measured: assessed at 6 weeks, 1 month, 4 months from baseline
Secondary outcomes (4)
Pediatric Evaluation of Disability Index-Mobility Subscale
The Pediatric Evaluation of Disability Index is a valid and reliable tool that provides an assessment of a child's functional status and performance via observation and parent report.The Mobility Subscale examines the child's functional skills related to movement. There are a total of 13 motor categories on the Mobility Subscale, with 5 possible motor skills in each category, for a total of 65 distinct motor skills. Skills are marked as 0 (not observed) or 1 (observed) and added.There are a total of 65 possible points with a range of 0-65 points on the Mobility Subscale. Higher scores indicate greater function.Scores are reported as changes from baseline.
Measured: pre-intervention, at 6 weeks, at 1-month and at 4-months following the intervention
Timed 10-meter Walk Test
The child's walking speed is recorded over 10 meters if the child is able to walk with or without an assistive device. The speed is timed and reported in seconds. Fewer seconds indicate a faster walking speed. Time in seconds is reported as change from baseline.
Measured: assessed at 6 weeks, at 1-month and at 4-months following the intervention
Peabody Developmental Motor Scales-2 -Locomotion Subscale
Peabody Developmental Motor Scales-2 is a norm-referenced standardized test of gross and fine motor performance for children from birth through age 5.The Locomotion Subscale examines the ability of the child to move through space. It contains a total of 89 motor skills. The child is rated on each skill on a scale of 0 (unable), 1 (partial) or 2 (complete) and the scores are added for a total possible raw score of 178 and a range of 0-178. Higher raw scores indicate a better outcome.The raw scores can be converted to standard scores, age equivalents and percentiles Raw scores of the Locomotion subscale are reported based on changes from baseline.
Measured: assessed at 6 weeks, at 1-month and at 4-months
1-minute Walk Test
The child's walking distance is measured in meters over 1 minute at their self-selected walking speed if the child is able to walk with or without an assistive device.The walking distance is reported in meters. More meters indicate more distance covered. Values are reported in meters as changes from baseline.
Measured: assessed at 6 weeks, 1 month, 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2015 (estimated)
- Study startJul 2015
- Primary completionSep 2018
- Study completionSep 2018
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- California State University, Sacramento
- Sponsor type
- University, hospital or other
- Collaborators
- Seattle Children's Hospital, University of Puget Sound, Thrasher Research Fund
- Responsible party
- Principal investigator, Katrin Mattern-Baxter, California State University, Sacramento
- Investigators
- David Earwicker, BA,MA, Study director, California State University, Sacramento
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02424526
- Sponsor's protocol ID
- 13-14-156
- Status last verified
- Jun 2020
- First submitted
- 16 Apr 2015
- Last updated
- 2 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Mattern-Baxter K, Looper J, Zhou C, Bjornson K. Low-Intensity vs High-Intensity Home-Based Treadmill Training and Walking Attainment in Young Children With Spastic Diplegic Cerebral Palsy. Arch Phys Med Rehabil. 2020 Feb;101(2):204-212. doi: 10.1016/j.apmr.2019.09.015. Epub 2019 Nov 1.
PubMed 31678223
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Home-based Treadmill Training and Walking Attainment in Young Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT02424526
- Acronym / sponsor ID
- 13-14-156
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, treadmill training, walking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- California State University, SacramentoUniversity, hospital or other
- Collaborators
- Seattle Children's Hospital, University of Puget Sound, Thrasher Research Fund
- Study start
- Jul 2015 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 23 Apr 2015 (estimated)
- Results
- Posted 2 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to find the optimal dosage of home-based treadmill training needed to accelerate walking onset and to examine the long-term effects on the child's walking activity.
Detailed description
The purpose of this study is to determine optimal parameters for dosing home-based treadmill training by comparing high-intensity (5 days/week, twice daily for 10-20 min for 6 weeks) to low-intensity (2 days/week, once daily for 10-20 minutes for 6 weeks) treadmill training; and to compare the effects of high- versus low-intensity treadmill training on walking attainment and overall walking activity in young children with cerebral palsy.
Hypotheses
- A more intensive protocol of treadmill training will increase walking onset in young children with CP.
- A more intensive protocol of treadmill training will increase overall walking activity in young children with CP.
Specific Aims
- To determine optimal parameters for dosing home-based treadmill training by comparing high-intensity to low-intensity home-based treadmill training.
- To compare the effects of high- versus low-intensity treadmill training on walking onset and overall walking activity.
Study design •Prospective randomized controlled trial
Study population
•Two groups of 12 children with CP under the age of 3 years and are not walking yet will receive either home-based high-intensity treadmill training or low-intensity treadmill training. The children will be assessed before, immediately after, at 1-month and at 4-months following the intervention via standardized outcome measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high-intensity group | Active comparator | Other: home-based treadmill training, Device: TreadmillChildren will engage in home-based treadmill training 5 days/week, twice daily for 10-20 min for 6 weeks |
| low-intensity group | Active comparator | Other: home-based treadmill training, Device: TreadmillChildren will engage in home-based treadmill training 2 days/week, once daily for 10-20 minutes for 6 weeks |
Who may qualify
- Ages
- 1 year to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Signs of walking readiness as demonstrated by the ability to sit for 30 seconds when placed and to take 5 to 7 steps when supported at the trunk or arms.
- Because young children often are not formally diagnosed with CP until 2 years of age, we will include children
Key exclusion criteria (5 listed)
- a history of uncontrolled seizures
- a diagnosis of a genetic disorder
- cardiac or orthopedic contraindications for standing and walking
- orthopedic surgery in the past 6 months
- use of spasticity-reducing medication or Botox injections in the past 6 months
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 |
|---|---|---|
| home-based treadmill trainingthe child will walk on a pediatric treadmill with the help of the parent/caregiver and with weekly supervision of a physical therapist | Other | high-intensity group, low-intensity group |
| Treadmill | Device | high-intensity group, low-intensity group |
Primary outcome
Gross Motor Function Measure Dimension E
Time frame: assessed at 6 weeks, 1 month, 4 months from baseline
The Gross Motor Function Measure is a criterion-referenced test of gross motor function for children with cerebral palsy ages 5 months to 15 years. It contains 5 Dimensions (A-E). Dimension E is related to the child's gross motor skills related to walking, running and jumping and is assessed by observation. Dimension E contains 24 gross motor skills. Each of these motor skills is rated either 0 (does not initiate), 1(initiates), 2 (partially completes), 3 (completes) or NT( not tested). The total possible Dimension E score is 72 with a range of 0-72. Scores can be converted into a percent score by dividing the child's achieved points by the number of possible points. Higher scores and a higher percentage indicate better performance in walking, running and jumping. Change from baseline in total points, not in percentage, is reported.
Walking Activity Measured by StepWatch
Time frame: StepWatch data was collected for all awake daytime hours over a 7 day period at study onset before treadmill training commences and at 6 weeks, 1 month, 4 months.
StepWatch data records the child's walking activity in minutes/day. It is collected via an accelerometer attached to the distal leg and worn at all waking hours except during sleep and bath time.Higher numbers of active minutes indicate higher level of activity. Changes from baseline are reported.
Gross Motor Function Measure Dimension D
Time frame: assessed at 6 weeks, 1 month, 4 months from baseline
The Gross Motor Function Measure is a criterion-referenced test of gross motor function for children with cerebral palsy ages 5 months to 15 years. It contains 5 Dimensions (A-E).Dimension D is a test of gross motor function related to standing ability. The child's gross motor skills related to standing are assessed by observation. The test contains 13 gross motor skills. Each of these motor skills is rated either 0 (does not initiate), 1(initiates), 2 (partially completes), 3 (completes) or NT( not tested). The total possible Dimension D score is 39 with a range of 0-39. Scores can be converted into a percent score by dividing the child's achieved points by the number of possible points. Higher scores and a higher percentage indicate better performance in standing. Change from baseline in total points, not in percentage, is reported.
4 secondary outcomes
Pediatric Evaluation of Disability Index-Mobility Subscale
Time frame: pre-intervention, at 6 weeks, at 1-month and at 4-months following the intervention
Timed 10-meter Walk Test
Time frame: assessed at 6 weeks, at 1-month and at 4-months following the intervention
Peabody Developmental Motor Scales-2 -Locomotion Subscale
Time frame: assessed at 6 weeks, at 1-month and at 4-months
1-minute Walk Test
Time frame: assessed at 6 weeks, 1 month, 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31678223Mattern-Baxter K, Looper J, Zhou C, Bjornson K. Low-Intensity vs High-Intensity Home-Based Treadmill Training and Walking Attainment in Young Children With Spastic Diplegic Cerebral Palsy. Arch Phys Med Rehabil. 2020 Feb;101(2):204-212. doi: 10.1016/j.apmr.2019.09.015. Epub 2019 Nov 1.
- 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.
David Earwicker, BA,MA study director
California State University, Sacramento
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing home-based treadmill training and Treadmill in people with Cerebral Palsy, run by California State University, Sacramento 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 5 inclusion and 5 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 2 Jul 2020. 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 2 Jul 2020). 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?
Gross Motor Function Measure Dimension E (time frame: assessed at 6 weeks, 1 month, 4 months from baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02424526, which also lists 1 linked publication.
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 2 Jul 2020.