CompletedNot Applicable

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

United States108 participantsStarted 2016-09

Plain-language summary

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.

Who can participate

Age range2 Years – 8 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change in Gross Motor Function Measure (GMFM)-88

Timeframe: Baseline (pre-treatment) and 9 months 12 months, and 18 months following initiation of treatment.

Trial details

NCT IDNCT02897024

SponsorOhio State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-12

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