Cerebral PalsyNCT01732731
Effects of Intensive Locomotor Treadmill Training on Gross Motor Function in Young Children With Neuromotor Impairment
A study testing treadmill training in people with Cerebral Palsy, run by University of the Pacific.
Trial summary
The purpose of this project is to examine if early exposure to intensive, short-term locomotor treadmill training (LT) in young children with neuromotor impairment will help develop walking skills earlier, decrease the amount of outside assistance needed (such as a walker or crutches) as compared to children with… Read more about this study
- Who is it for?
- Ages 9 to 36 months
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- treadmill training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Apr 2009to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 9 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- a diagnosis of CP with GMFCS levels I and II
- ages 9 to 36 months
- the ability to sit for at least 30 seconds unsupported in ring-sitting or W-sitting
- the ability to take ten consecutive steps when held on hands
Who cannot join
- a diagnosis of a genetic syndrome
- independent ambulation without an assistive device
- previous or current use of treadmill intervention during physical therapy
- a medical contraindication for standing or walking defined by the physician 5) uncontrolled seizures
- a history of orthopedic surgery
- use of medication to control spasticity in the past 6 months
About this study
The purpose of this project is to examine if early exposure to intensive, short-term locomotor treadmill training (LT) in young children with neuromotor impairment will help develop walking skills earlier, decrease the amount of outside assistance needed (such as a walker or crutches) as compared to children with neuromotor impairment who receive traditional physical therapy intervention.
- Conditions
- Cerebral Palsy
- Being tested
- treadmill training
- Keywords
- Cerebral palsy, treadmill training
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treadmill trainingOther
Home-based treadmill training will be administered to the children in the experimental group
| Study group | Role | What they receive |
|---|---|---|
| treadmill training | Experimental | children will receive home-based treadmill training with supervision from a physical therapist Receives: Other: treadmill training |
| no treadmill training | No intervention | children will not receive treadmill training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Motor Function Measure Dimension D and E
Measured: up to 4-months post-intervention
Secondary outcomes (3)
Peabody Developmental Motor Scales-2
Measured: pre-intervention, 6-week post-intervention, 1-month post-intervention, 4-month post-intervention
timed 10 meter walk test
Measured: pre-intervention, 6-week post-intervention, 1-month post-intervention, 4-month post-intervention
Pediatric Evaluation of Disability Inventory
Measured: pre-intervention, 6-week post-intervention, 1-month post-intervention, 4-month post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2012 (estimated)
- Study startApr 2009
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Pacific
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katrin Mattern-Baxter, Principal investigator, University of the Pacific
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01732731
- Sponsor's protocol ID
- 09-97
- Other IDs
- 527109
- Status last verified
- Nov 2012
- First submitted
- 24 Sep 2012
- Last updated
- 26 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intensive Locomotor Treadmill Training on Gross Motor Function in Young Children With Neuromotor Impairment
- ClinicalTrials.gov ID
- NCT01732731
- Acronym / sponsor ID
- 09-97
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral palsy, treadmill training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of the PacificUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 26 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this project is to examine if early exposure to intensive, short-term locomotor treadmill training (LT) in young children with neuromotor impairment will help develop walking skills earlier, decrease the amount of outside assistance needed (such as a walker or crutches) as compared to children with neuromotor impairment who receive traditional physical therapy intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treadmill training | Experimental | Other: treadmill trainingchildren will receive home-based treadmill training with supervision from a physical therapist |
| no treadmill training | No intervention | –children will not receive treadmill training |
Who may qualify
- Ages
- 9 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- a diagnosis of CP with GMFCS levels I and II
- ages 9 to 36 months
- the ability to sit for at least 30 seconds unsupported in ring-sitting or W-sitting
- the ability to take ten consecutive steps when held on hands
Key exclusion criteria (6 listed)
- a diagnosis of a genetic syndrome
- independent ambulation without an assistive device
- previous or current use of treadmill intervention during physical therapy
- a medical contraindication for standing or walking defined by the physician 5) uncontrolled seizures
- a history of orthopedic surgery
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 |
|---|---|---|
| treadmill trainingHome-based treadmill training will be administered to the children in the experimental group | Other | treadmill training |
Primary outcome
Gross Motor Function Measure Dimension D and E
Time frame: up to 4-months post-intervention
3 secondary outcomes
Peabody Developmental Motor Scales-2
Time frame: pre-intervention, 6-week post-intervention, 1-month post-intervention, 4-month post-intervention
timed 10 meter walk test
Time frame: pre-intervention, 6-week post-intervention, 1-month post-intervention, 4-month post-intervention
Pediatric Evaluation of Disability Inventory
Time frame: pre-intervention, 6-week post-intervention, 1-month post-intervention, 4-month post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2012.
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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.
Katrin Mattern-Baxter principal investigator
University of the Pacific
Questions about this trial
What is this clinical trial studying?
A study testing treadmill training in people with Cerebral Palsy, run by University of the Pacific.
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 4 inclusion and 6 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 26 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 D and E (time frame: up to 4-months post-intervention). 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 26 Nov 2012.