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

NCT02897024 | Completed DMC

• 1 other identifier: 2016N0031
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

Cerebral Palsy; Motor Impairments

Outcome Measures

Primary Outcomes (1)

• Change in Gross Motor Function Measure (GMFM)-88

  GMFM evaluates change in gross motor function over time or with intervention in children

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

Secondary Outcomes (3)

• Change in Goal Attainment Scaling (GAS)

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

• Change in Bayley Scales of Infant Development III

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

• Change in Pediatric Evaluation and Disability Inventory (PEDI)

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

Other Outcomes (1)

• Change in Pediatric Outcomes Questionnaire (PODCI)

  Collected at 0, 4.5 and 9 months (during the treatment period)

Study Arms (2)

Usual weekly

ACTIVE COMPARATOR

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

Other: Physical Therapy

High intensity periodic

EXPERIMENTAL

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.

Other: Physical Therapy

Interventions

Physical Therapy OTHER

One-on-one physical therapy sessions (one therapist and one patient). Principles of motor learning used include repetition, task-specificity, active practice, generalization of skills, errors, structured practice, and developmentally appropriate feedback with sufficient time to practice.

High intensity periodic; Usual weekly

Eligibility Criteria

• Age: 2 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (2)

• Maus E, Sansuchat LA, Tripathi T, Heathcock JC. Mostly Mothers, Many Others: Comparing Caregiver Attendance and Missed Treatment Hours in Pediatric Physical Therapy for Children With Cerebral Palsy. Phys Ther. 2025 Nov 29;105(12):pzaf131. doi: 10.1093/ptj/pzaf131.

  PMID: 41206728 DERIVED

• 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.

  PMID: 34529078 DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Jill Heathcock, MPT, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 7, 2016
• First Posted: September 12, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: February 24, 2021

Record last verified: 2021-02

Locations

US (1)