Clinical Trials Directory

Trials / Completed

CompletedNCT02340026

Cerebral Palsy Early Mobility Training

Dynamic Supported Mobility for Infants and Toddlers With Cerebral Palsy

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
42 (actual)
Sponsor
Children's Hospital of Philadelphia · Academic / Other
Sex
All
Age
12 Months – 36 Months
Healthy volunteers
Not accepted

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.

Detailed description

This study is a single-blind, randomized exploratory clinical trial with repeated assessments during a 24-week treatment phase and at three follow-up points over 12 months after treatment to track the developmental trajectory of participants' motor function. Gross motor ability will be compared to published percentile scores of motor function development in cerebral palsy (CP) to determine if the trajectory of predicted motor development is altered, and to outcomes of intensity-matched conventional treatment to determine if continued Phase III investigation is warranted.

Conditions

Interventions

TypeNameDescription
OTHERDynamic Supported MobilityDynamic weight support; Child-directed; No assistive devices, limited use of orthoses, no treadmill; Encourage high degree of error with reduced physical assistance; Encourage frequent variability in motor tasks (no redirection when moving from one activity to another); Physical therapist expertise is focused on designing a salient and challenging environment for the child's specific interests and ability level to encourage engagement, variability, challenge, and error experience, and on determining the appropriate amount of weight assistance
OTHERConventional TherapyNo or static weight support; Therapist-directed (therapist initiates); Traditional early gait training methods: use of assistive devices/orthoses and may use treadmill; Focus on producing "typical" movement patterns with extensive manual guidance/correction from therapist, prevention of falls; Therapy activities grouped into blocks of practice (i.e. repeated floor to stand practice followed by gait training); Physical therapist expertise is focused on designing and directing the specific practice activities each session, tailored to the individual child

Timeline

Start date
2015-01-15
Primary completion
2019-04-01
Completion
2020-07-13
First posted
2015-01-16
Last updated
2025-11-04
Results posted
2024-09-19

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02340026. Inclusion in this directory is not an endorsement.