- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02897024
A Comparison: High Intense Periodic vs. Every Week Therapy in Children With Cerebral Palsy (ACHIEVE) (ACHIEVE)
February 23, 2021 updated by: Jill Heathcock, Ohio State University
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.
Study Overview
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 Type
Interventional
Enrollment (Anticipated)
108
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43205
- Nationwide Children's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 8 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Usual weekly
Usual weekly physical therapy is 1 hours of therapy one day per week for 40 weeks.
|
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.
|
Experimental: High intensity periodic
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline (pre-treatment) and 9 months 12 months, and 18 months following initiation of treatment.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Goal Attainment Scaling (GAS)
Time Frame: Baseline (pre-treatment) and 9 months 12 months, and 18 months following initiation of treatment.
|
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
|
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.
|
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.
|
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.
|
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.
|
Baseline (pre-treatment) and 9 months 12 months, and 18 months following initiation of treatment.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Pediatric Outcomes Questionnaire (PODCI)
Time Frame: Collected at 0, 4.5 and 9 months (during the treatment period)
|
Parent survey to assess patients under the age of 19 years for overall health, pain, and ability to participate in normal daily activities, as well as more vigorous activities typically associated with young people.
The target populations are children and adolescents ages 2-18 years with general health problems, specifically any problems related to bone and muscle conditions.
|
Collected at 0, 4.5 and 9 months (during the treatment period)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2016
Primary Completion (Actual)
December 1, 2020
Study Completion (Actual)
December 1, 2020
Study Registration Dates
First Submitted
September 7, 2016
First Submitted That Met QC Criteria
September 9, 2016
First Posted (Estimate)
September 12, 2016
Study Record Updates
Last Update Posted (Actual)
February 24, 2021
Last Update Submitted That Met QC Criteria
February 23, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016N0031
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cerebral Palsy
-
Gazi UniversityCompletedCerebral Palsy | Cerebral Palsy, Spastic | Cerebral Palsy Spastic Diplegia | Cerebral Palsy Quadriplegic | Cerebral Palsy, MonoplegicTurkey
-
Northwestern UniversityActive, not recruitingCerebral Palsy | Diplegic Cerebral Palsy | Bilateral Cerebral PalsyUnited States
-
Centre Médico-Chirurgical de Réadaptation des Massues...RecruitingCerebral Palsy, Dyskinetic | Cerebral Palsy, Spastic | Infantile Hemiplegic Cerebral PalsyFrance
-
St Mary's University CollegeUniversity of GloucestershireUnknownCerebral Palsy | Cerebral Palsy Ataxic | Cerebral Palsy, MixedUnited Kingdom
-
Hilde FeysHasselt University; ETH Zurich; Curtin UniversityRecruitingHemiplegic Cerebral Palsy | Cerebral Palsy, SpasticBelgium
-
University of California, San FranciscoNational Institutes of Health (NIH)RecruitingDystonic Cerebral Palsy | Dyskinetic Cerebral PalsyUnited States
-
MTI UniversityEnrolling by invitationSpastic Diplegic Cerebral PalsyEgypt
-
East Carolina UniversityRecruitingHemiplegic Cerebral Palsy | Unilateral Cerebral Palsy | Remote Ischemic ConditioningUnited States
-
October 6 UniversityCompletedSpastic Cerebral Palsy | Spastic Hemiplegic Cerebral PalsyEgypt
-
Marmara UniversityUnknownCerebral Palsy, Spastic | Cerebral Palsy, Spastic, DiplegicTurkey
Clinical Trials on Physical Therapy
-
Riphah International UniversityCompleted
-
Mayo ClinicDePuy OrthopaedicsCompleted
-
Universidad de ZaragozaCompletedPlagiocephaly | Plagiocephaly, Nonsynostotic | Plagiocephaly, PositionalSpain
-
International Hellenic UniversityNot yet recruitingChronic Pain | Neuropathic Pain | Cognitive Therapy
-
Ragaee Saeed MahmoudRecruiting
-
Iuliu Hatieganu University of Medicine and PharmacyCompletedParkinson DiseaseRomania
-
Universidad Rey Juan CarlosCompleted
-
University of AarhusCompleted
-
Riphah International UniversityCompletedAdhesive Capsulitis of ShoulderPakistan