Physical Therapy for Gross Motor Delays

(DRIVE Trial)

Overseen By Petra Sternberg, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Disqualifiers: Uncontrollable seizures, Progressive neurological disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 23

Duration: 5 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the best frequency and intensity of physical therapy for young children with cerebral palsy. Researchers will assign children to one of three groups, receiving therapy daily, several days a week, or weekly. The goal is to identify which schedule most effectively improves movement skills. Children aged 6 to 24 months with a diagnosis or risk of cerebral palsy who can handle two-hour therapy sessions may be suitable candidates.

As an unphased trial, this study provides a unique opportunity to contribute to understanding optimal therapy schedules for young children.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this physical therapy regimen is safe for children with cerebral palsy?

Research has shown that physical therapy is generally safe for children with developmental delays, including those with cerebral palsy. Studies have found that treatments focusing on large movements, such as physical therapy, can be effective without major safety concerns. In this study, safety is not a significant issue because physical therapy is a non-invasive treatment that uses exercises and activities to improve movement. Participants will engage in varying amounts of therapy, but the activities are similar and aim to enhance large motor skills. Reports indicate no serious side effects from physical therapy in children, making it a well-tolerated and safe option for improving movement in young children with cerebral palsy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores different intensities of physical therapy for improving gross motor delays. Unlike the standard approach, which typically involves consistent weekly sessions, this trial includes a unique daily therapy option providing intensive two-hour sessions for 20 consecutive weekdays, potentially accelerating progress. By comparing daily, intermediate, and usual weekly therapy schedules, researchers aim to uncover the most effective frequency for fostering motor skill development, which could lead to more personalized and efficient treatment plans for individuals with motor delays.

What evidence suggests that physical therapy might be an effective treatment for cerebral palsy?

Research has shown that physical therapy effectively aids children with movement difficulties, including those with cerebral palsy. In this trial, participants will receive therapy at varying frequency levels. Studies have found that task-specific training can significantly enhance overall movement skills and foster independence in children. Exercise programs that develop motor skills prove especially beneficial for young children. Furthermore, activities targeting large movements can lead to notable improvements in both movement abilities and daily tasks. These findings support the role of structured physical therapy as a crucial component in treating movement challenges in children with cerebral palsy. ^{1 4 6 7 8}

Who Is on the Research Team?

Jill Heathcock, MPT, PhD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

This trial is for young children aged 6 to 24 months with cerebral palsy or gross motor delays, specifically in GMFCS levels III-V. They must be able to handle a 2-hour therapy session and not be enrolled in another daily treatment program. Children with progressive neurological disorders, uncontrollable seizures, or sensory conditions that limit participation are excluded.

Inclusion Criteria

My child is between 6 months and 2 years old, adjusted for premature birth.

I can handle a 2-hour therapy session, as confirmed by my parent and therapist.

I have cerebral palsy or am at risk, with moderate to severe mobility issues.

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

I do not have hearing or vision problems that would stop me from fully participating in treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one of three levels of physical therapy: daily, intermediate, or weekly, for a total of 40 hours over 5 months

5 months

Varies by group: daily (20 visits), intermediate (20 visits), weekly (20 visits)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Assessments at 3, 6, 12, 18, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Physical Therapy

Trial Overview The study aims to find the best frequency and intensity of physical therapy for children with cerebral palsy by comparing three groups: one receiving daily sessions, one intermediate frequency, and one weekly. The 'dose' of rehabilitation will consider the number of sessions per week, overall duration, and intensity.

How Is the Trial Designed?

Group I: Frequency Level 3 - Usual Therapy Experimental Treatment 1 Intervention

Level 3 usual weekly physical therapy is 2 hours of therapy one day per week for 20 weeks.

Group II: Frequency Level 2 - Intermediate Therapy Experimental Treatment 1 Intervention

Level 2 intermediate physical therapy is 2 hours of therapy per day 3 days per week for 6.6 weeks

Group III: Frequency Level 1 - Daily Therapy Experimental Treatment 1 Intervention

Level 1 daily physical therapy is 2 hours of one-on-one physical therapy per day for 20 straight weekdays

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Published Research Related to This Trial

The Basic Gross Motor Assessment was specifically developed to evaluate minor motor problems in children, addressing the inadequacies of existing measures used for more severely disabled children.

The assessment was normed on a large sample of 1,260 children and validated with an additional 285 subjects, demonstrating its reliability and effectiveness in identifying children who may need further physical therapy evaluation or treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Basic gross motor assessment. Tool for use with children having minor motor dysfunction. Hughes, JE., Riley, A.[2019]

A systematic review of 9 trials involving children with Developmental Coordination Disorder (DCD) and Cerebral Palsy (CP) found that only two trials showed any significant effect of physical therapy interventions on gross motor skills, indicating limited effectiveness of current therapies.

While some interventions demonstrated a large beneficial effect in improving gross motor outcomes, the overall evidence quality was rated as very low, highlighting the need for more rigorous and higher-quality studies in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to improve gross motor performance in children with neurodevelopmental disorders: a meta-analysis. Lucas, BR., Elliott, EJ., Coggan, S., et al.[2022]

The proactive physical therapy (PAPT) program for people with Parkinson disease (PD) was successfully implemented at a rehabilitation center, targeting individuals before significant mobility issues arose, and resulted in a doubling of participants engaging in regular exercise over six months.

Participants in the PAPT program reported substantial physical and emotional benefits, with a notable increase in aerobic exercise participation and balance activities, highlighting the program's effectiveness in promoting long-term independent exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Implementation Frameworks to Provide Proactive Physical Therapy for People With Parkinson Disease: Case Report. Rafferty, MR., MacDonald, J., Byskosh, A., et al.[2020]

Physical therapy interventions can lead to significant improvements in gross motor skills (GMSs) for individuals with intellectual disabilities, particularly through specific training methods like body-weight-supported gait training and adapted judo training.

Despite some positive outcomes, the overall quality of evidence is low, with only two randomized controlled trials included in the review, highlighting the need for more robust research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical therapy interventions for gross motor skills in people with an intellectual disability aged 6 years and over: a systematic review. Hocking, J., McNeil, J., Campbell, J.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12287077/

Early rehabilitation interventions for global developmental ... Physical therapy constitutes a cornerstone of early intervention strategies for children with developmental delays affecting motor skills and ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0965229925001037

The efficacy of physical activity or exercise among ... Task-oriented training led to large improvements in gross motor function (SMD = 6.04–11.05) and functional independence (SMD = 6.44). VR-based and aerobic ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11148274/

Motor development-focused exercise training enhances gross ... This study aims to offer an updated meta-analysis regarding the effectiveness of motor development-focused exercise training on gross motor skills in preschool ...

4. mdpi.com mdpi.com/2077-0383/13/16/4609

Evaluating the Efficacy of Gross-Motor-Based Interventions ... This review quantitatively evaluates the effectiveness of gross-motor-based interventions in children with developmental coordination disorder (DCD).

5. research.aota.org research.aota.org/ajot/article/74/2/7402180060p1/6681/Interventions-Within-the-Scope-of-Occupational

Interventions Within the Scope of Occupational Therapy ... An RCT found significant improvements in gross and fine motor skills and most Pediatric Evaluation of Disability Inventory (PEDI) scores for ...

6. journals.lww.com journals.lww.com/iaph/fulltext/9900/knowledge_and_awareness_of_developmental_delays,.22.aspx

Knowledge and awareness of developmental delays, ... Of the 40 participants, 70% were aware of physical therapy, but only 42.5% knew and used proper lifting techniques. In addition, 55% of ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1728869X25000425

Comparing gross motor performance, physical fitness ... The overall development of gross motor skills and physical fitness in children with SID was observed to be comparatively delayed relative to children with TSID.

8. researchgate.net researchgate.net/publication/394656747_Knowledge_and_awareness_of_developmental_delays_the_role_of_physiotherapy_in_gross_motor_delays_and_effective_lifting_and_carrying_techniques_among_parents_of_children_with_developmental_delays_-_An_o

Knowledge and awareness of developmental delays, the ... Statistical analysis was performed using SPSS. RESULTS Of the 40 participants, 70% were aware of physical therapy, but only 42.5% knew and used ...