NCT01253083

Mobility Training to Improve Motor Behavior in Toddlers With or at Risk for Cerebral Palsy: A Pilot Study

Completed Phase 1 Last updated 17 December 2019

What this trial tests

Phase 1 trial testing mobility training with dynamic body weight support in Developmental Delay in 5 participants. Completed in 6 June 2014.

Timeline

15 November 2010

Primary endpoint
6 June 2014

6 June 2014

Quick facts

Lead sponsor	National Institutes of Health Clinical Center (CC)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	5
Start date	15 November 2010
Primary completion	6 June 2014
Estimated completion	6 June 2014
Sites	1 location across United States

Drugs / interventions tested

• mobility training with dynamic body weight support

Conditions studied

• Developmental Delay — all drugs for Developmental Delay →
• Cerebral Palsy — all drugs for Cerebral Palsy →

Sponsor

National Institutes of Health Clinical Center (CC)

Who can join

Adults 12 Months to 36 Months, any sex, with Developmental Delay or Cerebral Palsy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background:

\- People who have cerebral palsy often have difficulty walking and moving their legs. Cerebral palsy is sometimes not identified until a child is almost 2 years of age, which means that early motor skill development can be affected and can have repercussions for later development. Studies in adults with neurological injuries (e.g., stroke, spinal cord injury) have shown that it is important to start intensive therapy soon after the injury, and it may be true that starting intensive therapy at a young age will be helpful for children with cerebral palsy. Researchers are interested in testing the effectiveness of a special body weight support system for mobility training in young children who have or are at risk for cerebral palsy.

Objectives:

\- To study the effectiveness of a mobility training program on the motor skills of young children who have or are at risk for cerebral palsy.

Eligibility:

\- Children between 12 and 36 months of age who have delayed motor skills and either have been diagnosed with cerebral palsy or show evidence of spasticity or brain damage.

Design:

* This study involves two 6-week study phases: a baseline phase and a mobility training program.
* Participants will be screened with a physical examination and medical history.
* During the baseline phase, participants will have mobility testing sessions once every 2 weeks. These tests will measure motor development and ability, including ease and speed of walking.
* Participants' parents/guardians will receive a mobility sensor for the child to wear at home for at least 6 hours (awake time) to measure activity and mobility levels outside of the testing sessions.
* After 6 weeks of baseline testing, participants will have 6 weeks of mobility training for 30 minutes 3 days per week. Training will involve motor tasks with weight support, conducted by a pediatric physical therapist. Activities may include walking, climbing inclines or steps, or squatting to reach toys. All sessions will be videotaped.
* To evaluate the effects of the therapy program, participants will have testing sessions every 2 weeks.
* Parents/guardians will also complete questionnaires to provide feedback on the effectiveness of the therapy program.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.