Cerebral Palsy Early Mobility Training (NCT02340026) | Clinical Trial Compass
CompletedNot Applicable
Cerebral Palsy Early Mobility Training
United States42 participantsStarted 2015-01-15
Plain-language summary
The purpose of this study is to determine the optimal treatment duration of a novel early mobility training program (dynamic supported mobility, DSM) between 6 to 24 weeks of treatment; and to evaluate the clinical futility of this intervention compared to current rehabilitation practice.
Who can participate
Age range
12 Months – 36 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 12-36 months of age
* Gross motor function below the 10th percentile for age \[Bayley Scales of Infant and Toddler Development (BSID), BSID-III, corrected for gestational age, if applicable, under the age of two years\].
* Diagnosis of CP or neurological sign associated with CP (i.e. spasticity).
* Ability to initiate pulling to stand at a surface \[Score of 1 on gross motor function measure (GMFM) Item 52\].
* Cognitive ability to follow one-step commands.
Exclusion Criteria:
* Secondary orthopedic, neuromuscular or cardiovascular condition unrelated to CP.
* General muscle hypotonia, without other neurological signs associated with CP.
* Independent walking ability (Score of 3 on GMFM Item 69 - Walks forward 10 steps).
* At or above the 50th percentile of GMFCS Level I.
* History of surgery or injury to the lower extremities in the past 6 months.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Gross Motor Function Measure (GMFM-66) During Treatment Phase