Post-operative Lite Run Study

NCT03135145 | Completed DMC FDA Device

• 1 other identifier: LiteRun-001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Single Event Multilevel Lower Extremity Orthopedic Surgery (SEMLS); Physical Therapy; Gait Training; Functional Walking; Selective Dorsal Rhizotomy (SDR)

Outcome Measures

Primary Outcomes (3)

• Number of subjects with treatment-related adverse events as assessed by CTCAE v, 4.

  Adverse events will be tracked for each subject enrolled in the study.

  Through study completion, up to 60 days

• Number of Pass or Fail grades for setting up the Lite Run device

  This measure will look at how easy Lite Run is to set up with a Pass or Fail grade by a trained Observer.

  Through study completion, up to 60 days

• Reduction of physical assistance by study Physical Therapists as assessed by the ordinal scale for the Walk item of the WeeFim II ® Locomotion subscale

  This measure will look at whether use of the Lite Run device will decrease the physical assistance needed for ambulation compared to standard of care treatments.

  Through study completion, up to 60 days

Secondary Outcomes (8)

• Reduction of physical assistance for sit-to-stand mobility for participants assessed by the ordinal scale 1-6 for the Transfer: Chair item of the WeeFIM II® Transfer subscale

  Through study completion, up to 60 days

• Increased duration of therapeutic weight-bearing activities in minutes

  Through study completion, up to 60 days

• Reduction of Pain during physical therapy for Non-Verbal children assessed by the Non-communicating Children's Pain Check List - Postoperative Version

  Through study completion, up to 60 days

• Reduction of Pain during physical therapy for Children

  Through study completion, up to 60 days

• Reduction of Anxiety levels during therapy for children ages 8 to 17 years will be assessed with the Visual Analog Anxiety Scale .

  Through study completion, up to 60 days

Study Arms (2)

Lite Run Gait Trainer

ACTIVE COMPARATOR

Participants will be using the Lite Run Gait Trainer to assist them in weightbearing and walking after SDR or SEMLS surgery.

Device: Lite Run Gait Trainer

Usual Treatments

PLACEBO COMPARATOR

Participants will be using current treatments used in clinical practice to assist them in weightbearing and walking after SDR or SEMLS surgery.

Other: Usual Treatments

Interventions

Lite Run Gait Trainer DEVICE

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.

Also known as: Lite Run, DHF No: 55-0001, 55-0002 & 55-0003

Lite Run Gait Trainer

Usual Treatments OTHER

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

Usual Treatments

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• diagnosis of cerebral palsy, neurologic syndrome, chromosomal abnormalities, spina bifida, or other neurological disorders
• age 4-17
• recent single event multilevel lower extremity orthopedic surgery or selective dorsal rhizotomy
• referred for physical therapy for mobility/gait training to regain functional walking and ambulation

You may not qualify if:

• Gross Motor Function Classification System levels I (walk and run in the community with only limitations in balance, coordination and speed) and V (use wheelchair to maintain sitting and for whole body mobility) prior to surgical intervention
• Subjects who are too large or too small to fit within the current Lite Run pants/prototype. The minimum patient weight is 50 lbs. The maximum patient weight is 350 lbs.
• Subjects that do not have clearance for full weight-bearing at the first treatment session

Sponsors & Collaborators

• Gillette Children's Specialty Healthcare: lead
• Lite Run Inc.: collaborator

Study Sites (1)

Gillette Children's Specialty Healthcare

Saint Paul, Minnesota, 55101, United States

Location

Related Publications (10)

• Aaslund MK, Moe-Nilssen R. Treadmill walking with body weight support effect of treadmill, harness and body weight support systems. Gait Posture. 2008 Aug;28(2):303-8. doi: 10.1016/j.gaitpost.2008.01.011. Epub 2008 Mar 17.

  PMID: 18343664 BACKGROUND

• Azaula M, Msall ME, Buck G, Tremont MR, Wilczenski F, Rogers BT. Measuring functional status and family support in older school-aged children with cerebral palsy: comparison of three instruments. Arch Phys Med Rehabil. 2000 Mar;81(3):307-11. doi: 10.1016/s0003-9993(00)90076-5.

  PMID: 10724075 BACKGROUND

• Bell KJ, Ounpuu S, DeLuca PA, Romness MJ. Natural progression of gait in children with cerebral palsy. J Pediatr Orthop. 2002 Sep-Oct;22(5):677-82.

  PMID: 12198474 BACKGROUND

• Breau LM, Finley GA, McGrath PJ, Camfield CS. Validation of the Non-communicating Children's Pain Checklist-Postoperative Version. Anesthesiology. 2002 Mar;96(3):528-35. doi: 10.1097/00000542-200203000-00004.

  PMID: 11873023 BACKGROUND

• Christensen D, Van Naarden Braun K, Doernberg NS, Maenner MJ, Arneson CL, Durkin MS, Benedict RE, Kirby RS, Wingate MS, Fitzgerald R, Yeargin-Allsopp M. Prevalence of cerebral palsy, co-occurring autism spectrum disorders, and motor functioning - Autism and Developmental Disabilities Monitoring Network, USA, 2008. Dev Med Child Neurol. 2014 Jan;56(1):59-65. doi: 10.1111/dmcn.12268. Epub 2013 Oct 1.

  PMID: 24117446 BACKGROUND

• Darragh AR, Campo M, King P. Work-related activities associated with injury in occupational and physical therapists. Work. 2012;42(3):373-84. doi: 10.3233/WOR-2012-1430.

  PMID: 22523031 BACKGROUND

• Han B, Enas NH, McEntegart D. Randomization by minimization for unbalanced treatment allocation. Stat Med. 2009 Nov 30;28(27):3329-46. doi: 10.1002/sim.3710.

  PMID: 19739238 BACKGROUND

• Hanna SE, Rosenbaum PL, Bartlett DJ, Palisano RJ, Walter SD, Avery L, Russell DJ. Stability and decline in gross motor function among children and youth with cerebral palsy aged 2 to 21 years. Dev Med Child Neurol. 2009 Apr;51(4):295-302. doi: 10.1111/j.1469-8749.2008.03196.x.

  PMID: 19391185 BACKGROUND

• Johnson DC, Damiano DL, Abel MF. The evolution of gait in childhood and adolescent cerebral palsy. J Pediatr Orthop. 1997 May-Jun;17(3):392-6.

  PMID: 9150031 BACKGROUND

• McKinley S, Coote K, Stein-Parbury J. Development and testing of a Faces Scale for the assessment of anxiety in critically ill patients. J Adv Nurs. 2003 Jan;41(1):73-9. doi: 10.1046/j.1365-2648.2003.02508.x.

  PMID: 12519290 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy; Nervous System Diseases; Chromosome Aberrations; Spinal Dysraphism

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neural Tube Defects; Nervous System Malformations; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Joyce Trost, PT

  Gillette Children's Specialty Healthcare

  PRINCIPAL INVESTIGATOR

• John Hauck

  Lite Run Inc.

  PRINCIPAL INVESTIGATOR

• Doug Johnson

  Lite Run Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Manager of Research Administration

Model Details: This is a single group repeated measures cross-over design. The study will include 4 sessions for each participant, with 2 sessions conducted using the Lite Run and 2 sessions conducted using the method of choice of the therapist (Usual Treatment).

Study Record Dates

• First Submitted: March 22, 2017
• First Posted: May 1, 2017
• Study Start: May 15, 2017
• Primary Completion: September 15, 2019
• Study Completion: September 15, 2019
• Last Updated: February 21, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)