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

75 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Physical Therapy for Gross Motor Delays?

Research shows that physical therapy can help improve gross motor skills in children with neurodevelopmental disorders, as it involves exercises and activities that enhance movement abilities. Additionally, a group-based treadmill program has been found to support walking skills in young children with neuromotor delays. ^{1 2 3 4 5}

Is physical therapy safe for children with gross motor delays?

The research does not specifically address safety concerns, but physical therapy is generally considered safe for children, as it is a common practice used to help improve motor skills in various conditions. ^{1 5 6 7 8}

How is the treatment of physical therapy for gross motor delays different from other treatments?

Physical therapy for gross motor delays is unique because it focuses on improving movement skills through exercises and interventions tailored to individual needs, rather than using medications or surgical options. It can include specific tools like foot orthoses to address issues like excessive pronation, which helps in promoting functional skills. ^{1 2 6 7 9}

Research Team

Jill Heathcock, MPT, PhD

Principal Investigator

Ohio State University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Interventions to improve gross motor performance in children with neurodevelopmental disorders: a meta-analysis. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Use of orthoses and early intervention physical therapy to minimize hyperpronation and promote functional skills in a child with gross motor delays: a case report. [2006]

3. United States pubmed.ncbi.nlm.nih.gov

Participation in Physical Play and Leisure in Children With Motor Impairments: Mixed-Methods Study to Generate Evidence for Developing an Intervention. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Using Implementation Frameworks to Provide Proactive Physical Therapy for People With Parkinson Disease: Case Report. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Analysis of a Group-Based Treadmill Program for Children with Neuromotor Delay Who Are Pre-Ambulatory. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Basic gross motor assessment. Tool for use with children having minor motor dysfunction. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Physical therapy intervention for children with cerebral palsy who receive botulinum toxin a injections. [2006]

8. Canada pubmed.ncbi.nlm.nih.gov

Gross Motor Outcomes of Children Born Prematurely in Northern Ontario and Followed by a Neonatal Follow-Up Programme. [2019]

9. Australia 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. [2018]