Cerebral PalsyACHIEVENCT02897024
A Comparison: High Intense Periodic vs. Every Week Therapy in Children With Cerebral Palsy (ACHIEVE)
A study testing Physical Therapy in people with Cerebral Palsy, run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 8 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
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.
Read the 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.
- Conditions
- Cerebral Palsy
- Being tested
- Physical Therapy
- Keywords
- Cerebral Palsy, Motor Impairments
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual weekly | Active comparator | Usual weekly physical therapy is 1 hours of therapy one day per week for 40 weeks. Receives: 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. Receives: Other: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gross Motor Function Measure (GMFM)-88
GMFM evaluates change in gross motor function over time or with intervention in children
Measured: Baseline (pre-treatment) and 9 months 12 months, and 18 months following initiation of treatment.
Secondary outcomes (3)
Change in Goal Attainment Scaling (GAS)
GAS creates patient, family, and clinical anchors as the external criterion for improvement by establishing activity or participation goals that reflect what an individual, family, and clinician consider meaningful or relevant.The GAS method allows for goals to be defined at different levels of mastery and assigned numerical values for score calculation, similar to a Likert scale. The scale will have 5 points representing different levels of mastery of the individual patient's goal. A score of -2 represents baseline, -1 less change than expected, 0 for the expected level of change, and +1 and +2 for achievement of more change than expected. To attempt to ensure ordinality, each level on the scale will be described and will reflect a single dimension of change that is measureable, achievable, and relevant
Measured: Baseline (pre-treatment) and 9 months 12 months, and 18 months following initiation of treatment.
Change in Bayley Scales of Infant Development III
The Bayley Scales of Infant and Toddler Development-Third Edition is an individually administered test designed to assess developmental functioning of infants and toddlers. The Bayley-III assesses development in five areas: cognitive, language, motor, social-emotional, and adaptive behavior.
Measured: Baseline (pre-treatment) and 9 months 12 months, and 18 months following initiation of treatment.
Change in Pediatric Evaluation and Disability Inventory (PEDI)
Administered as a parent survey. The PEDI is a descriptive measure of a child's current functional performance and can track changes over time. The PEDI measures both capability and performance of functional activities in three content domains: self-care, mobility, and social function.It can be used as a comprehensive clinical assessment of key functional capabilities and performance in children between the ages of six months and seven years.
Measured: Baseline (pre-treatment) and 9 months 12 months, and 18 months following initiation of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Jill Heathcock, Ohio State University
- Investigators
- Jill Heathcock, MPT, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02897024
- Sponsor's protocol ID
- 2016N0031
- Acronym
- ACHIEVE
- Status last verified
- Feb 2021
- First submitted
- 7 Sep 2016
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rosales M, Rittler A, Heathcock J. Human-animal interactions: starting with pets of children with cerebral palsy. BMC Complement Med Ther. 2026 Apr 10;26(1):189. doi: 10.1186/s12906-026-05342-1.
PubMed 41957633Maus 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.
PubMed 41206728Scott 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.
PubMed 34529078
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison: High Intense Periodic vs. Every Week Therapy in Children With Cerebral Palsy (ACHIEVE)
- ClinicalTrials.gov ID
- NCT02897024
- Acronym / sponsor ID
- ACHIEVE / 2016N0031
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral Palsy, Motor Impairments
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- Sep 2016 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 12 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual weekly | Active comparator | Other: Physical TherapyUsual weekly physical therapy is 1 hours of therapy one day per week for 40 weeks. |
| High intensity periodic | Experimental | Other: Physical TherapyHigh 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. |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical TherapyOne-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. | Other | High intensity periodic, Usual weekly |
Primary outcome
Change in Gross Motor Function Measure (GMFM)-88
Time frame: Baseline (pre-treatment) and 9 months 12 months, and 18 months following initiation of treatment.
GMFM evaluates change in gross motor function over time or with intervention in children
3 secondary outcomes
Change in Goal Attainment Scaling (GAS)
Time frame: Baseline (pre-treatment) and 9 months 12 months, and 18 months following initiation of treatment.
Change in Bayley Scales of Infant Development III
Time frame: Baseline (pre-treatment) and 9 months 12 months, and 18 months following initiation of treatment.
Change in Pediatric Evaluation and Disability Inventory (PEDI)
Time frame: Baseline (pre-treatment) and 9 months 12 months, and 18 months following initiation of treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
- Derived from this study: PubMed 41957633Rosales M, Rittler A, Heathcock J. Human-animal interactions: starting with pets of children with cerebral palsy. BMC Complement Med Ther. 2026 Apr 10;26(1):189. doi: 10.1186/s12906-026-05342-1.
- Derived from this study: PubMed 41206728Maus 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.
- Derived from this study: PubMed 34529078Scott 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jill Heathcock, MPT, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Therapy in people with Cerebral Palsy, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gross Motor Function Measure (GMFM)-88 (time frame: Baseline (pre-treatment) and 9 months 12 months, and 18 months following initiation of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02897024, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.