Clinical UM Guideline

This document addresses the indications for a pediatric gait trainer with trunk support, a device similar to a walker that is intended to provide balance, stability, and postural control in children who require moderate to maximum support for walking. This document does not address electromechanical or robotic-assisted devices.

Note: For information regarding powered gait training devices, please see the following:

• OR-PR.00006 Powered Robotic Lower Body Exoskeleton Devices

Note: For a high-level overview of this document, please see "Summary for Members and Families" below.

Medically Necessary:

A pediatric gait trainer with trunk support is considered medically necessary for an individual who meets all of the following criteria:

1. Is 18 years of age or younger; and
2. Requires moderate to maximum support for ambulation (for example, because of an injury such as spinal cord or traumatic brain injury or chronic illness: cerebral palsy, neuromuscular disease, or spina bifida); and
3. Demonstrates the ability to ambulate with the device.

Not Medically Necessary:

A pediatric gait trainer with trunk support is considered not medically necessary when the criteria are not met.

This document describes clinical studies and expert recommendations and explains when the use of pediatric gait trainers is clinically appropriate. The following summary does not replace the medical necessity criteria or other information in this document. The summary may not contain all of the relevant criteria or information. This summary is not medical advice. Please check with your healthcare provider for any advice about your health.

Key Information

A pediatric gait trainer is a walking aid designed for children who need a lot of help staying upright and moving forward. It looks like a walker but wraps around the child’s body to give more support. Gait trainers are used by children who have trouble walking due to conditions that impact the ability to control their bodies, such as cerebral palsy, spina bifida, traumatic brain injury, or spinal cord injury.

What the Studies Show

One randomized controlled trial tested gait trainer-assisted walking in children with cerebral palsy. The trial found that children who used a gait trainer along with physical therapy had better walking outcomes than children who had physical therapy alone. Children using the gait trainer showed greater improvement in how evenly they stepped and how long they supported weight on their weaker side.

A survey found that gait trainers were most often used by children with cerebral palsy; about one in five of these children used one. Nearly half of those children used the device every day.

Better studies are needed to know which type of gait trainer or training approach works best for each child.

When is a Pediatric Gait Trainer Clinically Appropriate?

A pediatric gait trainer with trunk support is clinically appropriate when the child is 18 years old or younger, needs moderate to maximum support to walk because of a condition such as spinal cord injury, traumatic brain injury, cerebral palsy, neuromuscular disease, or spina bifida, and is able to walk with the device.

When is this Not Clinically Appropriate?

A pediatric gait trainer is not clinically appropriate when the criteria above are not met.

(Return to Description)

The following codes for treatments and procedures applicable to this guideline are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services may be Medically Necessary when criteria are met:

When services are Not Medically Necessary:
For the procedure codes listed above when criteria are not met.

Summary

The evidence base for pediatric gait trainers consists of one randomized controlled trial with limited enrollment and one descriptive survey. One trial found between-group improvements in ambulation when gait trainer-assisted walking was added to traditional physical therapy in children with hemiparetic cerebral palsy. Taken together, the available evidence supports gait trainer use as an adjunct to physical therapy in appropriately selected children, while the literature on specific training modalities remains limited by small sample sizes and single-site designs.

Discussion

Device Use in Children with Disabilities

A descriptive survey by Peredo and colleagues (2010) examined medical equipment use among caregivers of children and adolescents (n=108) with motor disabilities. The most common diagnoses were cerebral palsy (45%), intellectual disability (19%), genetic abnormality (13%), spina bifida (13%), and neuromuscular diseases (7%). Mean age was 7.1 years (standard deviation [SD], 5.0). Gait trainers were used by 10 of 52 children (19%) with cerebral palsy and 1 of 14 children (7%) with a genetic abnormality; 5 of the 11 gait trainer users (46%) reported daily use.

Evidence from Randomized Controlled Trials

Gharib and colleagues (2011) assessed the effect of gait trainer-assisted exercise on walking performance in children with hemiparetic cerebral palsy. Thirty children from a single outpatient pediatric clinic were randomized to traditional physical therapy alone (control) or traditional physical therapy combined with gait trainer-assisted walking (experimental), with 15 participants per group. Both groups received 30-minute sessions 3 times per week for 3 months. The experimental group demonstrated significantly greater improvement in the ambulation index and time of support for the affected side compared to the control group (11.93 ± 2.89 vs. 2.13 ± 4.43; p=0.0001 and 7 ± 2.20 vs. 3.33 ± 6.25; p=0.007, respectively). Both groups showed within-group improvements in step length and walking speed. The observed between-group results support the use of gait trainer-assisted walking as an adjunct to traditional physical therapy for improving functional walking parameters.

Pediatric gait trainers are available from various manufacturers in multiple sizes and models. One such device is the Rifton Pacer Gait Trainer (Community Products, LLC dba Rifton Equipment, Rifton, NY), a walker designed for use by children with motor challenges. The basic unit consists of a lightweight aluminum frame with a stable U-shaped base and 4 large-diameter caster wheels. The casters include separate controls for brake, swivel lock, variable drag, and one-way ratchet, usable in any combination to regulate movement. The frame with prompts can be positioned anteriorly or posteriorly and telescopes for height adjustment across 3 sizes, accommodating user elbow heights from 44.5 cm to 119.5 cm.

Device Options

Other models include, but are not limited to: the Walkabout Gait Trainer (Meylan-Smith A/S, Denmark), a posterior support, weight-relieving device that provides dynamic pelvic support and is hands-free and open in the front; the KidWalk Gait Mobility System (Prime Engineering, Fresno, CA), an open-front, hands-free trainer with a swivel seat and support systems that track the child’s vertical and lateral motion to promote a natural walking pattern; and the Therapeutic Ambulatory Orthotic System (TAOS) (Sky Medical, Inc., Sunrise, FL), an orthotic and walker-based device designed to provide children with cerebral palsy an upright, hands-free environment.

The U.S. Food and Drug Administration (FDA) categorizes gait trainers as Class I devices under product codes ITJ (walker, mechanical) and NXE (walker, mechanical, poly vinyl chloride), each with a 510(k)-exempt submission type (FDA, 2023, 2024).

Cerebral palsy (CP): A group of disorders that can involve brain and nervous system functions, such as movement, learning, hearing, seeing, and thinking. CP results from an event affecting the immature, developing brain, most often before birth. Signs and symptoms appear during infancy or preschool years. In general, cerebral palsy causes impaired movement associated with exaggerated reflexes, floppiness or rigidity of the limbs and trunk, abnormal posture, involuntary movements, unsteadiness of walking, or some combination of these. Some individuals may have difficulty with swallowing, eye muscle imbalance, or reduced range of motion at various joints of their bodies due to muscle stiffness. Some individuals are able to walk, while others are not. Some individuals show normal to near-normal intellectual function, while others may have intellectual disabilities due to underlying developmental brain abnormalities. Epilepsy, blindness, or deafness also may be present.

Gross Motor Function Classification System (GMFCS): A five-level classification system (Levels I-V) for cerebral palsy based on self-initiated movement with particular emphasis on sitting (truncal control) and walking. Distinctions between levels of motor function are based on functional limitations, the need for assistive technology, including mobility devices (such as walkers, crutches, and canes) and wheeled mobility, and, to a much lesser extent, quality of movement. Children in Level II do not require assistive mobility devices after age 4, while children in Level III require assistive mobility devices to walk (Palisano, 1997).

Spina bifida: Part of a group of birth defects called neural tube defects that include spinal cord malformation presenting in varying degrees of severity and impairment. Functional deficits include, but are not limited to, lower limb paralysis, sensory loss, and cognitive dysfunction.

Traumatic brain injury (TBI): Occurs when an external mechanical force causes brain dysfunction, often associated with a diminished or altered state of consciousness, and potentially leads to permanent or temporary impairment of cognitive, physical, and psychosocial functions. TBI usually results from a violent blow or jolt to the head or body but can also be caused by an object penetrating the skull.

Peer Reviewed Publications:

1. Davies PL, Soon PL, Young M, Clausen-Yamaki A. Validity and reliability of the school function assessment in elementary school students with disabilities. Phys Occup Ther Pediatr. 2004; 24(3):23-43.
2. Gharib NM, El-Maksoud GM, Rezk-Allah SS. Efficacy of gait trainer as an adjunct to traditional physical therapy on walking performance in hemiparetic cerebral palsied children: a randomized controlled trial. Clin Rehabil. 2011; 25(10):924-934.
3. Palisano R, Rosenbaum P, Walter S, et al. Development and reliability of a system to classify gross motor function in children with cerebral palsy. Dev Med Child Neurol. 1997; 39(4):214-223.
4. Peredo DE, Davis BE, Norvell DC, Kelly PC. Medical equipment use in children with disabilities: a descriptive survey. J Pediatr Rehabil Med. 2010; 3(4):259-267.

Government Agency, Medical Society, and Other Authoritative Publications:

1. U.S. Food and Drug Administration Product Classification Database. Walker, Mechanical. Product code ITJ. Rockville, MD: FDA. April 10, 2024. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?id=ITJ. Accessed on March 14, 2026.
2. U.S. Food and Drug Administration Product Classification Database. Walker, Mechanical, Poly Vinyl Chloride (PVC). Product code NXE. Rockville, MD: FDA. March 6, 2023. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?id=NXE. Accessed on March 14, 2026.

1. American Academy of Physical Medicine and Rehabilitation (AAPMR). Available at: http://www.aapmr.org/Pages/default.aspx. Accessed on March 14, 2026.
2. U.S. National Library of Medicine. National Institutes of Health. MedlinePlus. Cerebral palsy. Updated November 23, 2025. Available at: http://www.nlm.nih.gov/medlineplus/cerebralpalsy.html. Accessed on March 14, 2026.

KidWalk Gait Mobility System
Rifton Pacer Gait Trainer
Therapeutic Ambulatory Orthotic System (TAOS)
Walkabout Gait Trainer

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another and is not intended to represent a complete listing of all products available.

Federal and State law, as well as contract language, and Medical Policy take precedence over Clinical UM Guidelines. We reserve the right to review and update Clinical UM Guidelines periodically. Clinical guidelines approved by the Medical Policy & Technology Assessment Committee are available for general adoption by plans or lines of business for consistent review of the medical necessity of services related to the clinical guideline when the plan performs utilization review for the subject. Due to variances in utilization patterns, each plan may choose whether to adopt a particular Clinical UM Guideline. To determine if review is required for this Clinical UM Guideline, please contact the customer service number on the member's card.

Alternatively, commercial or FEP plans or lines of business which determine there is not a need to adopt the guideline to review services generally across all providers delivering services to Plan's or line of business's members may instead use the clinical guideline for provider education and/or to review the medical necessity of services for any provider who has been notified that his/her/its claims will be reviewed for medical necessity due to billing practices or claims that are not consistent with other providers, in terms of frequency or in some other manner.

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