What side effects are associated with this type of intervention?

Common treatments for Cerebral Palsy include physical and occupational therapy, as well as medications like baclofen, benzodiazepines, and botulinum toxin injections. Physical and occupational therapy are generally safe but may cause temporary discomfort or fatigue. Baclofen and benzodiazepines can lead to side effects such as drowsiness, dizziness, and muscle weakness. Botulinum toxin injections, used for localized spasticity, may cause pain at the injection site, temporary weakness, and in rare cases, systemic effects like difficulty swallowing or breathing.

What prior FDA approvals exist?

FDA-approved treatments for cerebral palsy primarily focus on managing symptoms and improving motor function. Medications such as oral baclofen are used to reduce spasticity and improve mobility. Physical and occupational therapies are also critical components of treatment, aiming to enhance motor skills, coordination, and overall functional abilities. These therapies often involve exercises, strength training, and the use of assistive devices to support daily activities.

What other types of research exist?

Promising novel alternatives for cerebral palsy treatment include: 1) Neurologic music therapy combined with functional resistance exercise, which has shown improvements in gross motor capacity. 2) Robotic-assisted locomotor treadmill therapy, which has demonstrated improvements in gait parameters, function, speed, and endurance. 3) Home-based programs using patterned sensory enhancement to augment resistance exercise effects. These alternatives offer innovative approaches to enhancing motor function in CP patients.

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Telemedicine-Based Constraint Therapy for Cerebral Palsy (APPLES-TELE Trial)

N/A

Recruiting

Led By Nathalie Maitre, MD, PhD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of CP or classification of high-risk for CP as determined by published guidelines (>95% risk of later CP)

Aged 4 to 13 months, corrected age

Must not have

Congenital malformation of the brain or musculoskeletal system (MSK)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 6 (after the first intervention), week 12 (after the second intervention)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests two therapies for infants with cerebral palsy: one delivered via telehealth and one focused on parent-led activities at home. Both aim to improve hand and arm function by involving parents in consistent exercises.

Who is the study for?

This trial is for infants aged 4 to 13 months at risk of or diagnosed with cerebral palsy, who have been patients in certain clinics. They must show arm movement differences and haven't had long-term constraint programs, brain or musculoskeletal malformations, or recent botulinum toxin treatments.

What is being tested?

The study compares two active treatments: APPLES-tele and PCA Support Intervention against standard care. Infants will receive these interventions in different sequences to see which is more effective for early childhood development.

What are the potential side effects?

As this trial involves non-pharmaceutical interventions focused on therapy and support, traditional side effects like those from medication are not applicable. However, there may be fatigue or frustration during the exercises.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am diagnosed with or at high risk for cerebral palsy.

Select...

My child is between 4 to 13 months old, considering their corrected age.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I was born with a brain or musculoskeletal system malformation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 6 (after the first intervention), week 12 (after the second intervention)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 6 (after the first intervention), week 12 (after the second intervention)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 6 (after the first intervention), week 12 (after the second intervention) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Bayley Scales of Infant and Toddler Development (Bayley-3) More Affected Arm Motor Function Score

Change in Parenting Styles and Dimensions Questionnaire (PSDQ) Authoritative Scale Score

Secondary study objectives

Change in Bayley Scales of Infant and Toddler Development (Bayley-3) Global Fine Motor Function Score

Change in Hand Assessment in Infants (HAI) Score

Change in Infant Motor Activity Log (IMAL) How Often Score

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: PCA first, then APPLES-teleExperimental Treatment3 Interventions

Participants receiving the PCA intervention for 6 weeks followed by the APPLES-tele intervention for 6 weeks.

Group II: APPLES-tele first, then PCAExperimental Treatment3 Interventions

Participants receiving the APPLES-tele intervention for 6 weeks followed by the PCA intervention for 6 weeks.

Group III: Standard of Care Control ArmActive Control1 Intervention

Participants receiving the standard of care for 6 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Standard of Care

2017

Completed Phase 4

~4420

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Cerebral Palsy (CP) include physical and occupational therapy, botulinum toxin injections, and oral antispasticity medications. Physical and occupational therapy aim to improve motor function and daily living skills through targeted exercises and activities that enhance strength, coordination, and flexibility. Botulinum toxin injections temporarily reduce spasticity by blocking nerve signals to the muscles, which helps in delaying muscle shortening and improving range of motion. Oral antispasticity medications, such as baclofen and benzodiazepines, work by relaxing muscles and reducing muscle stiffness. These treatments are crucial for CP patients as they help manage spasticity, improve functional abilities, and enhance overall quality of life.

Case for gait analysis as part of the management of incomplete spinal cord injury.