N/A
Completed N=41
Cerebral Palsy Early Mobility Training
Source: ClinicalTrials.gov NCT02340026 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcomePrimary: Change in Gross Motor Function Measure (GMFM-66) During Treatment Phase — 2.2; 3.5 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Gross Motor Function Measure (GMFM-66) During Treatment Phase |
2.2; 3.5 | — |
| SECONDARY Change in Postural Control |
2.7; 4.3 | — |
| SECONDARY Change in Physical Activity |
1.4; -2.6 | — |
| SECONDARY Change in Caregiver Satisfaction |
1.5; 2.5 | — |
| SECONDARY Change in Child Engagement in Daily Life |
0.96; 3.8 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02340026). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.