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Gait Trainers and Standing Devices

Policy Number: MP-727

Name of Policy: Gait Trainers and Standing Devices 

Latest Review Date: August 2021

Category: DME

Policy Grade: D

POLICY:

Standing Devices

Standing Devices may be considered medically necessary when the following criteria are met:

There is documentation that the stander is necessary for the user to be independent in one or more of the following activities of daily living in his/her home:

1. Eating,

2. Personal hygiene,

3. Toileting,

4. Dressing, or

5. Transfer.

AND

The patient is unable to accomplish the above activities with their current DME device or equipment.

OR

There is documentation that off-loading of a decubitus ulcer cannot be accomplished by other means.

AND

The patient has completed a one-month trial using the standing device/gait trainer and has shown meaningful improvement after the trial period. Documentation from the referring provider must show that the patient has shown meaningful improvement during the trial period.

Standing devices requested for vocational usage are considered not medically necessary.

Gait Trainers

Gait Trainers may be considered medically necessary when the following criteria are met:

There is documentation of the patient’s mobility limitation;

AND

The patient has the potential for ambulation;

AND

The patient is unable to accomplish gait training activities with their current DME device or equipment.

AND

There is a written home therapy plan (a plan for treatment in the home rather than an institutional setting) developed with emphasis on skill carryover, and goals that target the member's functional use of the requested gait trainer in the home, and there is a caretaker who can appropriately supervise use of the gait trainer.

Gait trainers are non-covered if the following applies:

  • There is no expected improvement in mobility or maintenance of function.

  • The member currently has equipment to accomplish the same purpose.

  • The equipment is non-medical, such as a glider.

  • Deluxe features that do not contribute to the therapeutic function of the gait trainer.

Standing devices or Gait Trainers for the sole purpose of helping a patient reach high places or storage areas are considered not medically necessary.

Accessories that are not primarily used to serve a medical purpose and are primarily used for comfort and/or convenience of the member or member's family including, but not limited to color options, tote bags, cup holders, baskets, are considered not medically necessary.

Accessories that are used to serve a medical purpose (e.g. knee pads, elbow pads, tray for anterior support) that are upgraded over the standard product are considered not medically necessary.

DESCRIPTION OF PROCEDURE OR SERVICE:

A stander is a device that enables the user of a wheeled mobility device (wheelchair or wheelchair and seated positioning system) to achieve a passive standing position. The devices are available by physician prescription only. There are three basic types of standers: supine, prone, and upright.

  • Supine standers support the back surface of the body and require the least amount of trunk and head control.

  • Prone standers support the front of the body while the user is supported in various angles.

  • Upright standers are used primarily in the vertical position by individuals who have fair to good trunk and head control.

  • Multi-positional standers combine all three types of standers into a single stander to allow for a variety of positioning needs. They are equipped with cushions to secure the head, trunk, hip, knees and feet. A foot operated pneumatic tilt permits the angle of the stander to be adjusted.

Standing devices have been proposed for patients who are wheelchair dependent including, but not limited to, patients with cerebral palsy, spinal cord injuries, muscular dystrophy, paraplegia, quadriplegia, multiple sclerosis, spina bifida, traumatic brain injury and paralytic syndromes.

Proposed medical benefits of standing include:

  • Improve/maintain bone integrity/skeletal development

  • Lessen/manage the progression of scoliosis

  • Strengthen cardiovascular system and build endurance

  • Improve Circulation

  • Reduce Swelling

  • Improve bowel function and regularity

  • Aid in kidney and bladder functions

  • Improve/maintain range of motion

  • Management of atrophy in the trunk and lower extremities

  • Manage pressure (ulcers) through changing positions

  • Improve strength to trunk and lower extremities

  • Decrease joint/muscle contractures

Gait trainers are assistive devices which enable a patient to be placed in an upright position to learn or relearn mobility skills safely and efficiently. Gait trainers are lightweight and may be equipped with armrests, seat and chest supports. Gait trainers have been proposed for patients with spinal cord injuries, broken legs or pelvis, strokes or neurological disorders, muscular dystrophy or other musculoskeletal disorders.

Gait training has been proposed for patients who have had an illness or injury that affects their ability to get around or walk. Proposed medical benefits of gait training include:

  • Strengthen your muscles and joints

  • Improve your balance and posture

  • Build your endurance

  • Develop your muscle memory

  • Retrain your legs for repetitive motion

  • Lower your risk of falls, while increasing your mobility

Meaningful improvement after a one month trial of a standing device may include: improvement in the functional use of the arms or hands, or head and trunk control, improvements in the performance of activities of daily living (ADLs), or improvements in digestive, respiratory, circulatory or excretory function, and skin integrity, by off-loading weight through standing (e.g., relief of pressure sores not achievable by other means). Improvements in skin integrity may include lack of progression or signs of healing in the decubiti ulcer.

POLICY GUIDELINES:

Standers and Gait trainers require individualized, patient specific medical justification from the patient’s orthopedic surgeon, neurologist, developmental pediatrician, or physiatrist to determine medical necessity. Justification must be submitted for review that includes the patient’s diagnosis, a narrative description with functional criteria for the stander or gait trainer, and any requested non-standard features, including wheels. At a minimum, such documentation must include all of the following:

A. Diagnosis, prognosis and severity of condition;

B. A description of functional goals and current standing/gait training program;

C. Reevaluation of the member at the end of the trial period for the standing/gait training program (e.g., how long and how many times per day or week the stander/gait trainer was used) and documented effectiveness of standing/gait training trial program;
D. History of standing and compliance when a stander is requested; assessment of ability to ambulate or potential to ambulate when a gait trainer is requested.
E. If nonstandard features are requested (e.g., mobile [wheeled] or multi-positional standing device) an explanation as to why a standard device is inadequate for the particular activity or indication AND that other standard devices have been trialed and found inadequate to meet the patient's needs;

F. Other DME equipment the patient currently uses; and

G. Relevant medical records.

When a wheelchair-integrated model is requested, a review is conducted to determine when the last wheelchair was obtained. If it is within 2 years, an additional allowance is made only for the basic standing device.

KEY POINTS:

Literature review performed through August 2021.

STANDING DEVICE

Cross-sectional study comparing 3 groups of patients with SCI: patients with daily standing times of more than 1 hour, patients with daily standing times of less than 1 hour, and non-standing patients. Seventy-one patients with chronic SCI were recruited. They were assigned to 1 of 3 groups according to their reported daily standing time. The bone density of lumbar and proximal femoral regions was measured with dual-energy x-ray absorptiometry. The 3 groups were similar in terms of demographics and clinical variables. No significant difference was found among the mean t-scores of lumbar and proximal femoral regions of the groups. However, the patients in the group that stood more than 1 hour daily had a slight tendency to have higher t-scores than those in the control group. There was no significant difference among the 3 groups. However, standing might be partially helpful in protecting the bone density in SCI by opposing the effects of immobilization.

Twenty community-dwelling people with motor complete spinal cord injury above T8 participated in a 16-week trial. The trial consisted of a 6-week stand phase and a 6-week no-stand phase separated by a 4-week washout period. Participants were randomised to one of two treatment sequences. Participants allocated to the Treatment First group stood on a tilt table for 30 min per session, five times per week for 6 weeks and then did not stand for the next 10 weeks. Participants allocated to the Control First group did the opposite: they did not stand for 10 weeks and then stood for 6 weeks. Participants in both groups received routine bowel care throughout the 16-week trial. Assessments occurred at weeks 0, 7, 10 and 17 corresponding with pre and post stand and no-stand phases. The primary outcome was Time to First Stool. There were seven secondary outcomes reflecting other aspects of bowel function and spasticity. There were three dropouts leaving complete data sets on 17 participants. The mean (95% confidence interval) between-intervention difference for Time to First Stool was 0 min (-7 to 7) indicating no effect of regular standing on Time to First Stool. Regular standing does not reduce Time to First Stool. Further trials are required to test the veracity of some commonly held assumptions about the benefits of regular standing for bowel function.

Early identification and intervention with conservative measures is important to help manage hip dysplasia in children with a high adductor and iliopsoas tone and delay in weight bearing. The effect of a daily standing program with hip abduction on hip acetabular development in ambulatory children with cerebral palsy was studied. The participants were 26 children with spastic diplegia cerebral palsy (CP), classified at Level III according to the Gross Motor Function Classification System (GMFCS). Thirteen children stood with hip abduction at least 1 h daily from 12 to 14 months of age to 5 years with an individually fabricated standing frame with hip abduction. At the age of 5 years, radiologic results of the study group were compared with a comparison group of 13 children with spastic diplegia CP who had not taken part in a standing program. The migration percentage in all children who stood with abduction remained within stable limits (13-23%) at 5 years of age, in comparison to children who did not stand in abduction (12-47%) (p < 0.01). The results indicate that a daily standing program with hip abduction in the first 5 years may enhance acetabular development in ambulatory children with spastic diplegia CP. Implications for Rehabilitation Abnormal acetabular development is a problem related to mobility problems and spasticity muscles around the hip. The literature suggests that postural management and standing programs could reduce levels of hip subluxation and increase function in children with cerebral palsy. A standing program with hip abduction can be a beneficial to develop more stable hips in children with spastic diplegic GMFCS level III.

There is a lack of evidence-based recommendations for effective dosing of pediatric supported standing programs, despite widespread clinical use. Standing programs 5 days per week positively affect bone mineral density (60 to 90 min/d); hip stability (60 min/d in 30° to 60° of total bilateral hip abduction); range of motion of hip, knee, and ankle (45 to 60 min/d); and spasticity (30 to 45 min/d).

Though standing programs as a therapeutic modality have been part of the program of management of children with developmental disorders and children and adults with spinal cord injuries for many years, there is very limited evidence in the peer reviewed literature of improvement in health outcomes attributable to standing.

Studies of very small groups of children suggest that weight-bearing activity may stimulate accrual of bone and reduction in muscle tone, however no reports of fracture rates or other health outcomes including bladder/bowel function, or incidence of contractures related to standing programs were found in a search of the scientific literature. While no studies of skin integrity related to standing programs were found, off-weighting of pressure areas is essential to treatment of skin breakdown.

GAIT TRAINERS:

Pediatric spinal cord injury (SCI) can result in permanent mobility impairment with consequences for activity, participation and quality of life. This case documents the effect of an over ground supported stepping intervention using a dynamic gait trainer. To our knowledge, there are no published studies on this intervention for children with SCI and similar interventions have only been reported in children at American Spinal Injury Association Impairment Scale (AIS) levels B and C.A child with a T10 (thoracic level, vertebra 10), AIS level A injury, sustained at 2 years of age, continued to make gains in all areas including participation, activity, body structure and function over the following 4 years. Use of a dynamic gait trainer improved the participant's ability to be active and participate despite lack of further neuromuscular recovery. This novel approach with a commonly available device allowed the child to be active and participate in the absence of neural recovery.

Weakness of trunk muscles is a common disorder in children with cerebral palsy (CP). They encounter decreased levels of endurance that can lead to diminished capacity of movement.

A RCT published by Shemy (2018), evaluated the effect of core stability training on the endurance of trunk muscles and gait parameters in children with hemiplegic CP. Thirty children with hemiplegic CP aged 10 to 12 years were randomly assigned to two groups of equal number; control group (A) and study group (B). Both groups underwent the same designed physical therapy program. Moreover, group B underwent core stability training 3 times/week for 8 weeks. Endurance time of trunk muscles and gait parameters were measured before and after the intervention using the trunk endurance tests and the Biodex gait trainer respectively. Both groups showed statistically significant improvements in the endurance time of trunk flexors and extensors and gait parameters after treatment but only group B showed statistically significant improvement in the endurance time of lateral trunk muscles. There were post-treatment statistically significant differences between both groups in favor of group B regarding all measured variables. Addition of core stability exercises to the treatment program can effectively improve the endurance time of trunk muscles and gait in children with hemiplegic CP.

Studies involved included at least one child with a mobility limitation and measured an outcome related to gait trainer use. Articles were appraised using American Academy of Cerebral Palsy and Developmental Medicine criteria for group and single-subject designs and quality ratings completed for studies rated levels I-III. The PRISMA statement was followed with inclusion criteria set a priori. Two reviewers independently screened titles, abstracts and full-text articles. Seventeen studies involving 182 children were included. Evidence from one small randomized controlled trial suggests a non-significant trend toward increased walking distance while the other evidence level II study (concurrent multiple baseline design) reports increased number of steps. Two level III studies (non-randomized two-group studies) report statistically significant impact on mobility level with one finding significant impact on bowel function and an association between increased intervention time and bone mineral density. Remaining descriptive level evidence provides support for positive impact on a range of activity outcomes, with some studies reporting impact on affect, motivation and participation with others.

A study of assistive devices and other environmental modifications, and their impact on everyday activities and care in young children with cerebral palsy (CP). Ninety-five children (55 boys, 40 girls; mean age 58 months, SD 18 months) and their parents were studied using a cross-sectional design. The Pediatric Evaluation of Disability Inventory (PEDI) was applied to assess daily activities using the three measurement scales: functional skills, caregiver assistance, and modifications of the environment. Use of modifications was described related to the five severity levels of the Gross Motor Function Classifications System (GMFCS). Impact was rated on the Caregiver Assistance scale of the PEDI and on a five-point Likert scale. Out of the 1075 provided environmental modifications, 980 were in regular use to support mobility, self-care and social function among 84 children. The number increased with GMFCS levels; children at levels IV and V used 80% of the modifications, with large variations between the children at same level. Adaptations of housing and transportation facilitated effective use of assistive devices. Half of the parents rated the modifications to have moderate to very large effect on the child's mobility, 25% on self-care skills, and 20% on social function. Furthermore, 65% reported that the modifications lightened the caregiving for mobility, 75% for self-care and 25% for social function. Functional independence and care demands often benefited from different types of modifications. The variations in use and benefits of environmental modifications indicate need of comprehensive assistive technology assessments, including child factors, family factors, technology factors and service system factors.

Practice Guidelines and Position Statements:

None identified.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Gait trainer, standing device, stander, supine standers, prone standers, upright standers, Rifton Supine Standers, Leckey Freestander, Jenx Monkey, Rifton Prone Stander, Tumbleform Tristander 45/58, Tumbleform 2 Tristander, Easy Stand Bantum, Ottobock

APPROVED BY GOVERNING BODIES:

Not applicable.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits. Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP contracts: FEP does not consider investigational if FDA approved and will be reviewed for medical necessity. Special benefit consideration may apply. Refer to member’s benefit plan.

CURRENT CODING:

HCPCS Codes:

E0637

Combination Sit To Stand Frame/Table System, Any Size Including Pediatric, With Seat Lift Feature, With Or Without

Wheels

E0638

Standing frame system, one position (e.g., upright, supine or prone stander), any size including pediatric, with or without wheels

E0641

Standing frame system, multi-position (e.g., three way stander), any size including pediatric, with or without wheels

E0642

Standing frame system, mobile (dynamic stander), any size including pediatric

E8000

Gait trainer, pediatric size, posterior support, includes all accessories and components

E8001

Gait Trainer, Pediatric Size, Upright Support, Includes All Accessories and Components

E8002

Gait trainer, pediatric size, anterior support, includes all accessories and components

REFERENCES:

  1. Altizer W, Noritz G, Paleg G Use of a dynamic gait trainer for a child with thoracic level spinal cord injury Case Reports 2017;2017:bcr-2017-220756.
  2. Caulton JM, Ward KA, Alsop CW, et al. A randomized controlled trial of a standing program on bone mineral density in nonambulant children with cerebral palsy. Archives of Disease in Childhood. 2004; 89:131-5.
  3. Eng JJ, et al. Use of prolonged standing for individuals with spinal cord injuries. Phys Ther 2001 Aug;81(8):1392-9.
  4. Glickman, LB, Geigle PR, Paleq GS. A systematic review of supported standing programs. J Pediatr Rehabil Med. 2010; 3(3):197- 213.
  5. Goktepe A., Does standing protect bone density in patients with chronic spinal cord injury? J Spinal Cord Med. 2008; 31(2):197-201.
  6. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
  7. Kwok S., Spinal Cord. Does regular standing improve bowel function in people with spinal cord injury? A randomised crossover trial. 2015 Jan;53(1):36-41.
  8. Macias-Merlo L, Bagur-Calafat C, Girabent-Farrés M, A Stuberg W. Disabil Rehabil.  Effects of the standing program with hip abduction on hip acetabular development in children with spastic diplegia cerebral palsy. 2016 Jun;38(11):1075-81.
  9. Ostensjo S, Carlberg EB, Vollestad NK. The use and impact of assistive devices and other environmental modifications on everyday activities and care in young children with cerebral palsy. Disabil Rehabil. 2005; 27(14):849-861.
  10. Paleg GS, Smith BA, Glickman LB Systematic review and evidence-based clinical recommendations for dosing of pediatric supported standing programs. Pediatr Phys Ther.2013 Fall;25(3):232-47.
  11. Paleg G, Livingstone R. Outcomes of gait trainer use in home and school settings for children with motor impairments: a systematic review. Clin Rehabil. 2015; 29(11):1077-1091.
  12. Shemy SA, Trunk endurance and gait changes after core stability training in children with hemiplegic cerebral palsy: A randomized controlled trial. J Back Musculoskelet Rehabil. 2018;31(6):1159-1167.
  13. Walter JS, Sola PG, Sacks J, Lucero Y, Langbein E, Weaver F. Indications for a home standing program for individuals with spinal cord injury. J Spinal Cord Med. 1999 Fall;22(3):152-8.

POLICY HISTORY:

New Medical Policy. DRAFT comment period through July 12, 2019.

Medical Policy Group, June 2020 (6): Updates to Key Points. No change to policy intent.

Medical Policy Group, December 2020 (6): Expanded policy statement to include non-covered statement regarding medical accessory upgrades.

Medical Policy Group, August 2021 (6): Updates to Key Points and References.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.