Clinical trial NCT02897024: A Comparison: High Intense Periodic vs. Every Week Therapy in Children With Cerebral Palsy (ACHIEVE)
Official title: A Comparison: High Intense Periodic vs. Every Week Therapy in Children With Cerebral Palsy (ACHIEVE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Cerebral Palsy
Motor Impairments
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2016-09-12
Enrollment: 108
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Gross Motor Function Measure (GMFM)-88
timeFrame: Baseline (pre-treatment) and 9 months 12 months, and 18 months following initiation of treatment.
Secondary outcomes:
measure: Change in Goal Attainment Scaling (GAS)
timeFrame: Baseline (pre-treatment) and 9 months 12 months, and 18 months following initiation of treatment.
measure: Change in Bayley Scales of Infant Development III
timeFrame: Baseline (pre-treatment) and 9 months 12 months, and 18 months following initiation of treatment.
measure: Change in Pediatric Evaluation and Disability Inventory (PEDI)
timeFrame: Baseline (pre-treatment) and 9 months 12 months, and 18 months following initiation of treatment.
Other outcomes:
measure: Change in Pediatric Outcomes Questionnaire (PODCI)
timeFrame: Collected at 0, 4.5 and 9 months (during the treatment period)
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Ohio State University
name: Jill Heathcock, MPT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Scott KS, Barbosa GO, Pan J, Heathcock JC. Using the PODCI to Measure Motor Function and Parent Expectations in Children With Cerebral Palsy. Phys Ther. 2021 Dec 1;101(12):pzab215. doi: 10.1093/ptj/pzab215.