Post-operative Lite Run 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.

Conditions

• Cerebral Palsy
• Neurologic Disorder
• Chromosome Abnormality
• Spina Bifida

Interventions

DEVICE

Lite Run Gait Trainer

Lite Run is a new system for the treatment of patients with gait and balance difficulties that uses differential air pressure inside a lower body suit to reduce up to 50 percent of a patient's body weight. The suit is similar to a pair of pants in appearance and is as easy to don and doff as a pair of pants. The suit uses technology like astronaut spacesuits to achieve comfort and flexibility while providing a unique "unweighting" effect that facilitates patient ambulation from sitting through taking steps. The suit is used in conjunction with the Lite Run Gait Trainer, which provides air pressure to the suit and support for the patient.

OTHER

Usual Treatments

The usual clinical treatments (standard of care treatments) will be used to assist patients in weightbearing and walking.

Sponsors & Collaborators

• Lite Run Inc.

  collaborator INDUSTRY

• Gillette Children's Specialty Healthcare

  lead OTHER

Principal Investigators

• Joyce Trost, PT · Gillette Children's Specialty Healthcare

• John Hauck · Lite Run Inc.

• Doug Johnson · Lite Run Inc.

Study Design

Allocation

RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

4 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-05-15

Primary Completion

2019-09-15

Completion

2019-09-15

FDA Device

Yes

Countries

• United States

Study Locations