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Lite Run Gait Trainer for Cerebral Palsy

N/A
Waitlist Available
Led By Doug Johnson
Research Sponsored by Gillette Children's Specialty Healthcare
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to 60 days
Awards & highlights

Study Summary

Lite Run is a new assistive device that may have FDA listing as a Class I device by mid 2017 based on clinical testing of adults, independent agency testing and in-house evaluations. This will be a combined study with multiple purposes with respect to the evaluation of its use with the post-operative pediatric population. A first purpose is to verify safety and feasibility of the device on pediatric patients. A second purpose is to statistically test the effectiveness of Lite Run to decrease physical burden on the therapist during post-operative gait training for children and adolescents with cerebral palsy as compared to current methods of body weight-supported gait training. A third purpose is to measure and qualitatively evaluate the effectiveness of the device on patient outcomes and improving patient and therapist satisfaction.

Eligible Conditions
  • Cerebral Palsy
  • Chromosome Abnormalities
  • Neurological Disorders
  • Spina Bifida

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to 60 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 60 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Pass or Fail grades for setting up the Lite Run device
Number of subjects with treatment-related adverse events as assessed by CTCAE v, 4.
Reduction of physical assistance by study Physical Therapists as assessed by the ordinal scale for the Walk item of the WeeFim II ® Locomotion subscale
Secondary outcome measures
Increased duration of therapeutic weight-bearing activities in minutes
Participant Satisfaction will be measured after each therapy visit with the QUEST Version 2.0 will be used, focusing on the first eight questions.
Reduction of Anxiety levels during therapy for children ages 4-7 years will be assess with the Children's Fear Scale "Scared".
+5 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Lite Run Gait TrainerActive Control1 Intervention
Participants will be using the Lite Run Gait Trainer to assist them in weightbearing and walking after SDR or SEMLS surgery.
Group II: Usual TreatmentsPlacebo Group1 Intervention
Participants will be using current treatments used in clinical practice to assist them in weightbearing and walking after SDR or SEMLS surgery.

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Who is running the clinical trial?

Gillette Children's Specialty HealthcareLead Sponsor
30 Previous Clinical Trials
11,492 Total Patients Enrolled
13 Trials studying Cerebral Palsy
5,871 Patients Enrolled for Cerebral Palsy
Lite Run Inc.Industry Sponsor
1 Previous Clinical Trials
10 Total Patients Enrolled
Doug JohnsonPrincipal InvestigatorLite Run Inc.

Frequently Asked Questions

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~1 spots leftby May 2025