A Comparison: High Intense Periodic vs. Every Week Therapy in Children With Cerebral Palsy (ACHIEVE)

The Ohio State University

Status: Completed

Conditions: Cerebral Palsy

Treatments: Other: Physical Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02897024

2016N0031

Details and patient eligibility

About

The ACHIEVE study is a comparison of the effectiveness of 2 intensities of physical therapy treatment for children with Cerebral Palsy in an outpatient physical therapy setting. High intensity periodic is 2 hours of focused and high intense treatment per weekday for 4 weeks. In comparison, usual weekly is considered standard of care; although both dosing models are used clinically for children with CP. Participants are assign to the treatment group at random. Participant who are unable to consent to randomization are allowed to chose a treatment group.

Full description

The overall goal of this project is to compare the effectiveness of high intense periodic and usual weekly therapy in treating Cerebral Palsy (CP) in children 2-8 years of age for motor rehabilitation. In this prospective randomized controlled trial (RCT), 108 children ages 2 to 8 years of age with CP will be enrolled and assigned to one of 2 service delivery models: 1 hour per day, 1 x per week for 40 weeks (usual weekly); and 2 hours every weekday for two 10-consecutive-weekdays (total 4 weeks), for a repeated "periodic" bout (high intense periodic). Participants unable to consent to randomization are allowed to chose a treatment group. All patients enrolled in ACHIEVE will also have 1 hour per month of Physical Therapy Consultation (PTC) during the treatment period of 40 weeks (9 months). PTCs provide monthly motor skill monitoring, consultation, and home therapy program progression. Outcome evaluations will be performed by blinded evaluators at baseline (month 0, before treatment), month 9 for all patients to assess short term effects, and at months 12 and 18 for patients to assess long term effects. Parent surveys will be collected at 0, 4.5, and 9 months only (PC-2). Short-term and long-term effects will be analyzed to determine individual differences in children's response to intensity. A subset will be analyzed at 12 and 18 month.

Enrollment: 108 estimated patients

Sex: All

Ages: 2 to 8 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 2 to 8 years of age at initiation of treatment
• a diagnosis of motor delay or CP in GMFCS levels 1-V
• ability to tolerate a 2 hour therapy session based on parent report and evaluating therapists.

Exclusion criteria

• uncontrollable seizures or any co-morbid condition that prevents full participation during treatment sessions
• participation in another daily treatment program in the last 6 months
• auditory or visual conditions that prevent full participation during treatment sessions
• Progressive neurological disorder with no potential for improvement.
• Recent surgery where physical therapy is contraindicated.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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108 participants in 2 patient groups

Usual weekly

Active Comparator group

Description:

Usual weekly physical therapy is 1 hours of therapy one day per week for 40 weeks.

Treatment:

Other: Physical Therapy

High intensity periodic

Experimental group

Description:

High intensity periodic physical therapy is 2 hours of therapy 5 days a week for 2 weeks, followed by an 18 week break, followed by another bout of high intensity therapy for 2 hours of therapy every weekday for two 10-consecutive-weekdays, followed by another 18 week break from therapy.

Treatment:

Other: Physical Therapy