Gross Motor Development DelayDRIVENCT02857933
Daily and Weekly Rehabilitation Delivery for Young Children With Gross Motor Delays
A study testing Physical Therapy in people with Gross Motor Development Delay, run by Ohio State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 24 months
- Conditions the study is for
- Gross Motor Development Delay
- What is being tested?
- Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
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.
Read the detailed description
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.
- Conditions
- Gross Motor Development Delay
- Being tested
- Physical Therapy
- Keywords
- Motor Impairments, Gross Motor Delay
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 |
|---|---|---|
| Frequency Level 1 - Daily Therapy | Other | Level 1 daily physical therapy is 2 hours of one-on-one physical therapy per day for 20 straight weekdays Receives: Other: Physical Therapy |
| Frequency Level 2 - Intermediate Therapy | Other | Level 2 intermediate physical therapy is 2 hours of therapy per day 3 days per week for 6.6 weeks Receives: Other: Physical Therapy |
| Frequency Level 3 - Usual Therapy | Other | Level 3 usual weekly physical therapy is 2 hours of therapy one day per week for 20 weeks. 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 with CP from 5 months to 16 years. It has been used widely in the field to determine functional motor change following intervention.
Measured: Baseline (pre-treatment) and 3 months, 6 months, 12 months, 18 months, and 24 months after 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 3 months, 6 months, 12 months, 18 months, and 24 months after 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 3 months, 6 months, 12 months, 18 months, and 24 months after 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 3 months, 6 months, 12 months, 18 months, and 24 months after 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 posted5 Aug 2016 (estimated)
- Study startApr 2016
- Primary completionOct 2024
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gross Motor Development DelayStudies 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- 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
- NCT02857933
- Sponsor's protocol ID
- 2015N0054
- Acronym
- DRIVE
- Status last verified
- Jan 2025
- First submitted
- 22 Jun 2016
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Scott K, Lewis J, Pan X, Heathcock J. Parent-Reported PEDI-CAT Mobility and Gross Motor Function in Infants With Cerebral Palsy. Pediatr Phys Ther. 2021 Jul 1;33(3):156-161. doi: 10.1097/PEP.0000000000000801.
PubMed 34086623Ferrante R, Hendershot S, Baranet K, Barbosa G, Carey H, Maitre N, Lo W, Pan J, Heathcock J. Daily and Weekly Rehabilitation Delivery for Young Children With Gross Motor Delay: A Randomized Clinical Trial Protocol (the DRIVE Study). Pediatr Phys Ther. 2019 Apr;31(2):217-224. doi: 10.1097/PEP.0000000000000594.
PubMed 30865149
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daily and Weekly Rehabilitation Delivery for Young Children With Gross Motor Delays
- ClinicalTrials.gov ID
- NCT02857933
- Acronym / sponsor ID
- DRIVE / 2015N0054
- Conditions
- Gross Motor Development Delay
- Keywords
- Motor Impairments, Gross Motor Delay
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Oct 2024 (actual)
- Study completion
- Apr 2026 (estimated)
- First posted
- 5 Aug 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 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Frequency Level 1 - Daily Therapy | Other | Other: Physical TherapyLevel 1 daily physical therapy is 2 hours of one-on-one physical therapy per day for 20 straight weekdays |
| Frequency Level 2 - Intermediate Therapy | Other | Other: Physical TherapyLevel 2 intermediate physical therapy is 2 hours of therapy per day 3 days per week for 6.6 weeks |
| Frequency Level 3 - Usual Therapy | Other | Other: Physical TherapyLevel 3 usual weekly physical therapy is 2 hours of therapy one day per week for 20 weeks. |
Who may qualify
- Ages
- 6 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 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.
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 | Frequency Level 1 - Daily Therapy, Frequency Level 2 - Intermediate Therapy, Frequency Level 3 - Usual Therapy |
Primary outcome
Change in Gross Motor Function Measure (GMFM)-88
Time frame: Baseline (pre-treatment) and 3 months, 6 months, 12 months, 18 months, and 24 months after initiation of treatment
GMFM evaluates change in gross motor function over time or with intervention in children with CP from 5 months to 16 years. It has been used widely in the field to determine functional motor change following intervention.
3 secondary outcomes
Change in Goal Attainment Scaling (GAS)
Time frame: Baseline (pre-treatment) and 3 months, 6 months, 12 months, 18 months, and 24 months after initiation of treatment
Change in Bayley Scales of Infant Development III
Time frame: Baseline (pre-treatment) and 3 months, 6 months, 12 months, 18 months, and 24 months after initiation of treatment
Change in Pediatric Evaluation and Disability Inventory (PEDI)
Time frame: Baseline (pre-treatment) and 3 months, 6 months, 12 months, 18 months, and 24 months after initiation of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Derived from this study: PubMed 34086623Scott K, Lewis J, Pan X, Heathcock J. Parent-Reported PEDI-CAT Mobility and Gross Motor Function in Infants With Cerebral Palsy. Pediatr Phys Ther. 2021 Jul 1;33(3):156-161. doi: 10.1097/PEP.0000000000000801.
- Derived from this study: PubMed 30865149Ferrante R, Hendershot S, Baranet K, Barbosa G, Carey H, Maitre N, Lo W, Pan J, Heathcock J. Daily and Weekly Rehabilitation Delivery for Young Children With Gross Motor Delay: A Randomized Clinical Trial Protocol (the DRIVE Study). Pediatr Phys Ther. 2019 Apr;31(2):217-224. doi: 10.1097/PEP.0000000000000594.
Related trials for Gross Motor Development Delay
RecruitingObservational study
Vestibular and Postural Function in Children Suspected of Balance Disorders
Children, Only, Vestibular Disorder
Enrolling by invitation
Ready, Set, Go! A Physical Fitness Intervention for Children With Mobility Challenges
Cerebral Palsy, Myelomeningocele
Recruiting
Effect of Task Specific Electrical Stimulation on Upper Limb Gross Motor Skills in Children With Spastic Quadriplegia
Cerebral Palsy (CP), Spastic Cerebral Palsy
Active, not recruiting
Grand Valley State University (GVSU) Skills on Wheels
Spina Bifida, Cerebral Palsy
RecruitingObservational study
Video-based Assessment of Preschool Children's Gross Motor Development
Gross Motor Development Delay
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 Gross Motor Development Delay, 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 4 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: under way, not looking for participants, as of the sponsor's last update on 31 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
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 3 months, 6 months, 12 months, 18 months, and 24 months after 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 NCT02857933, which also lists 2 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 31 Jan 2025.