Daily and Weekly Rehabilitation Delivery for Young Children With Gross Motor Delays
Status: | Recruiting |
---|---|
Conditions: | Neurology, Neurology |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | Any |
Updated: | 3/2/2019 |
Start Date: | April 2016 |
End Date: | April 2021 |
Contact: | Petra Sternberg, PhD |
Email: | Petra.sternberg@osumc.edu |
Phone: | 614-572-5446 |
The purpose of this study is to determine the optimal frequency and intensity of physical
therapy for children with cerebral palsy aged 6 to 24 months of age. Participants will be
randomly assigned to one of three groups: daily, intermediate, or weekly physical therapy.
Short and long term effects will be evaluated to determine the best 'dose' of rehabilitation
for children with cerebral palsy, including frequency (number of sessions per week and the
number of weeks), intensity (how hard the patient works), and time (how many total hours) of
rehabilitation treatment.
therapy for children with cerebral palsy aged 6 to 24 months of age. Participants will be
randomly assigned to one of three groups: daily, intermediate, or weekly physical therapy.
Short and long term effects will be evaluated to determine the best 'dose' of rehabilitation
for children with cerebral palsy, including frequency (number of sessions per week and the
number of weeks), intensity (how hard the patient works), and time (how many total hours) of
rehabilitation treatment.
Determining optimal frequency of treatment for young children with cerebral palsy (CP) has
implications for shaping the future of pediatric rehabilitation. There are wide variations in
the number of hours per week of treatment in current outpatient rehabilitation programs for
children with CP, suggesting clinical uncertainty. Usual weekly therapy at 1 - 2 hours per
week for 6 months or longer is the most commonly implemented frequency of dose for children
with CP 6 - 24 months of age. However, this decision about frequency is often made based on
clinical reasoning and scheduling, not on principles of rehabilitation, child development, or
evidence from strongly designed randomized controlled trials. The proposed study will fill
this gap by directly comparing the effects of 3 frequency levels of therapy - concentrated
daily, intermediate, and usual weekly in children with CP 6 - 24 months of age at the
initiation of treatment and following these patients for 2 years.
In this prospective longitudinal study, children with Cerebral Palsy (n=75), 6 - 24 months of
age, will be randomly assigned to one of three groups: daily, intermediate, or weekly
physical therapy. The treatment phase of this study design is 5 months for a total of 40
hours of one-on-one therapy for both groups. Level 1 daily therapy is 2 hours of therapy per
day for 20 straight weekdays. Level 2 intermediate therapy is 2 hours of therapy per day 3
days per week for 6.6 weeks. Level 3 usual weekly therapy is 2 hours of therapy one day per
week for 20 weeks. Researchers will directly compare the effects of 3 these frequency levels
of therapy at the initiation of treatment and following these patients for 2 years. Results
will provide quantitative evidence of frequency-response, which is critical for informing
clinical decision-making, health policy, and guidelines for reimbursement.
implications for shaping the future of pediatric rehabilitation. There are wide variations in
the number of hours per week of treatment in current outpatient rehabilitation programs for
children with CP, suggesting clinical uncertainty. Usual weekly therapy at 1 - 2 hours per
week for 6 months or longer is the most commonly implemented frequency of dose for children
with CP 6 - 24 months of age. However, this decision about frequency is often made based on
clinical reasoning and scheduling, not on principles of rehabilitation, child development, or
evidence from strongly designed randomized controlled trials. The proposed study will fill
this gap by directly comparing the effects of 3 frequency levels of therapy - concentrated
daily, intermediate, and usual weekly in children with CP 6 - 24 months of age at the
initiation of treatment and following these patients for 2 years.
In this prospective longitudinal study, children with Cerebral Palsy (n=75), 6 - 24 months of
age, will be randomly assigned to one of three groups: daily, intermediate, or weekly
physical therapy. The treatment phase of this study design is 5 months for a total of 40
hours of one-on-one therapy for both groups. Level 1 daily therapy is 2 hours of therapy per
day for 20 straight weekdays. Level 2 intermediate therapy is 2 hours of therapy per day 3
days per week for 6.6 weeks. Level 3 usual weekly therapy is 2 hours of therapy one day per
week for 20 weeks. Researchers will directly compare the effects of 3 these frequency levels
of therapy at the initiation of treatment and following these patients for 2 years. Results
will provide quantitative evidence of frequency-response, which is critical for informing
clinical decision-making, health policy, and guidelines for reimbursement.
Inclusion Criteria:
- an age of 6 months - 24 months at the initiation of treatment. The age will be
corrected for any eligible children born preterm until they are 2 years of age, as is
standard clinical and research practice
- a diagnosis or risk for CP in GMFCS levels III, IV and V or motor delay
- ability to tolerate a 2 hour therapy session based on parent report and evaluating
therapists, the same criteria the investigators used for the pilot study.
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.
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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