A Comparison: High Intense Periodic vs. Every Week Therapy in Children With Cerebral Palsy (ACHIEVE)
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Neurology, Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 2 - 8 |
| Updated: | 3/2/2019 |
| Start Date: | September 2016 |
| End Date: | September 2020 |
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.
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.
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.
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.
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.
We found this trial at
1
site
700 Childrens Drive
Columbus, Ohio 43205
Columbus, Ohio 43205
(616) 722-2000
Phone: 614-572-5446
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