8 Participants Needed

Physical Therapy for Cerebral Palsy in Infants

BS
SC
Overseen ByStacey C Dusing, PhD, PT
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: University of Southern California
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an intensive in-home program designed to help infants with or at high risk of cerebral palsy improve their ability to stand and walk. Researchers aim to determine if this program is practical and beneficial for these infants. The trial includes a 16-week intervention where infants practice standing and walking at home while continuing any other treatments recommended by their healthcare providers. Infants diagnosed with cerebral palsy or with specific brain imaging results indicating high risk are suitable candidates for this trial. As an unphased study, this trial offers infants a unique opportunity to potentially benefit from early intervention and contribute to valuable research.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this intervention is safe for infants with cerebral palsy?

Research shows that home-based standing and walking exercises for infants with cerebral palsy are generally safe. Studies have found that young children with cerebral palsy and other conditions can handle these exercise programs well. Similar programs have reported no major negative effects.

For example, one study examined a structured exercise program for children with cerebral palsy and found it safe and doable. Another study tested a standing program for children with a different condition and found no major safety issues.

These findings suggest that the in-home standing and walking exercises in this trial are likely safe. However, since every child is different, close monitoring during any new activity is important.12345

Why are researchers excited about this trial?

Researchers are excited about the in-home standing and walking intervention for infants with cerebral palsy because it offers a unique, naturalistic approach by integrating therapy into the child's everyday environment. Unlike traditional physical therapy that often requires visits to clinical settings, this method allows infants to receive therapy in the comfort of their own homes, potentially increasing convenience and consistency. Additionally, this intervention is designed to work alongside existing community-recommended therapies, aiming to enhance overall developmental outcomes in a more holistic way.

What evidence suggests that this in-home standing and walking intervention is effective for cerebral palsy in infants?

Research shows that home-based therapies can benefit infants with cerebral palsy. One study found that setting specific goals for home training improved infants' movement and function. Another study showed that structured home exercises helped infants walk farther and faster, enhancing their movement scores. Additionally, exercises involving varied standing positions improved children's quality of life over four months. These findings suggest that the in-home standing and walking intervention tested in this trial can enhance movement and overall function in infants with or at high risk of cerebral palsy.46789

Who Is on the Research Team?

BS

Barbara Sargent, PhD, PT

Principal Investigator

University of Southern California, Division of Biokinesiology and Physical Therapy

Are You a Good Fit for This Trial?

This trial is for infants diagnosed with cerebral palsy or those at high risk, indicated by brain imaging and specific neurological exam scores. Infants must be able to see toys and respond to sounds, weigh under 50 lbs, and live in an area accessible for home visits.

Inclusion Criteria

My infant is at high risk for or has been diagnosed with cerebral palsy.

Exclusion Criteria

Living in a location inaccessible by study personnel for in-home data collections
Prenatal substance abuse
Congenital malformations
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

8-weeks no intervention baseline period to assess initial conditions

8 weeks
Monthly visits (in-person)

Intervention

16-week in-home standing and walking intervention with body-weight support

16 weeks
Weekly telehealth calls, monthly home visits

Follow-up

8-weeks no intervention follow-up to monitor post-intervention effects

8 weeks
Monthly visits (in-person)

Long-term follow-up

Outcomes measured at 2 years of age to assess long-term effects

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

  • In-home standing and walking intervention
Trial Overview The study tests the practicality of a program where babies do standing and walking exercises at home. It aims to understand if this intervention can help infants with or at high risk of developing cerebral palsy.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: In-home standing and walking interventionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials
956
Recruited
1,609,000+

California Physical Therapy Association

Collaborator

Trials
1
Recruited
8+

Cerebral Palsy Foundation

Collaborator

Trials
3
Recruited
2,100+

Citations

Effectiveness of simple and basic home-based exercise ...GMFCS levels showed no statistically significant reduction after six and 12 weeks of intervention in the PM group (p > 0.05) when compared to the HEP group.
Feasibility and effectiveness of home-based therapy ...They concluded that home-based programmes using goal-directed training are effective in improving motor and functional outcomes. Another review by Sakzewski et ...
Structured home-based exercise program for improving ...Overall, these results showed the positive effect of SHEP on the walking distance, speed and GMFM-66 score of the study participants. These observations were ...
The THRIVE-CP Trial - Targeted Home-Based Training ...We will describe the overall change in movement behavior patterns after the intervention, including changes in the time spent walking, standing, ...
Dynamic Standing Exercise in a Novel Assistive Device ...The quality of life improved after a four-month exercise training period of DyS for children with CP-NA. The effect of DyS on our main outcome ...
Intensive Home-based Treadmill Training and Walking ...The purpose of this study is to determine optimal parameters for dosing home-based treadmill training by comparing high-intensity (5 days/week, twice daily for ...
Effects of a Standing Program for Ambulatory Children with ...This single-subject design study examined the impact of a home-based standing program on two ambulatory children with MMC, focusing on lower ...
Feasibility of an In-home Standing and Walking Intervention ...The purpose of this study is to evaluate the feasibility and begin to evaluate the effect of an intensive in-home standing and walking ...
The efficiency and use of a reciprocating system aid for ...This study on a sample of children demonstrated that the Moonwalker exoskeleton allows walking and training at home in children with severe CP.
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