Medical Policy


Subject:  Standing Frames
Policy #:  DME.00034Current Effective Date:  01/05/2016
Status:ReviewedLast Review Date:  11/05/2015

Description/Scope

This document addresses the use of standing frames, which are assistive devices that provide an alternative position for individuals confined to supine, prone, or sitting positions. These devices allow the individual to achieve a standing position and then support the person in the standing position. Standers can be integrated to use with wheelchairs for those in a sitting position. Other types of standing frames are designed to aid those in a prone or supine position to achieve a standing position.

Position Statement

Investigational and Not Medically Necessary:

Standing frames are considered investigational and not medically necessary for all indications.

Rationale

The published studies that address passive standing for individuals with neurological mobility disabilities, (for example, cerebral palsy, spinal cord injuries, and stroke) do not have consistent outcomes. The theory that passive standing enhances hip alignment, bone mineralization, urinary function, respiratory functioning and psychosocial functioning is not supported by the current available evidence.

Post-Stroke

Bagley and colleagues (2005) conducted a randomized controlled trial (RCT) of 170 post-stroke individuals in a rehabilitation unit. Participants were randomized to a control group (n=69) who received usual care and an intervention group (n=71) who received usual care with a minimum of 14 days treatment with a standing frame. There were no statistically significant differences between groups in measurements of mobility, motor skills, performance of activities of daily living, trunk control or anxiety or depression at 6 weeks, 12 weeks and 6 months post stroke (p=0.310; p=0.970 and p=0.282, respectively).

In a pilot RCT, Allison and colleague (2007) studied 17 post-stroke individuals in a rehabilitation unit. Individuals were allocated to a control group (conventional physiotherapy) or a treatment group (conventional therapy plus an additional session of standing practice). Duration of study was variable depending upon the length of time the individual was inpatient, from 14 to 28 days. Balance, gross motor function and trunk control were assessed upon admission, weekly during the intervention stage and 12 weeks following discharge. At week 12, the treatment group reported a statistically significant improvement (p<0.05) in balance scores compared to the scores of the control group. While the treatment group also reported an improvement in motor function scores over the control group, the difference was not statistically significant. The authors concluded that a larger study is required to establish the value of additional standing practice after stroke.

Cerebral palsy (CP)

Caulton and colleagues (2004) studied severely disabled children with CP to determine whether participation in 50% longer periods of standing (in either upright or semi-prone standing frames) would lead to an increase in the vertebral and proximal tibial volumetric trabecular bone mineral density (vTBMD), which affects low trauma fractures. A heterogeneous group of pre-pubertal children with CP (n=26) participated and were matched into pairs using baseline vertebral vTBMD standard deviation scores. Children within the pairs were randomly allocated to control (regular standing duration) or intervention (50% increase in the regular standing duration) groups. The median standing duration varied from 80.5% (range, 9.5%-102%) and 140.6% (range, 108.7%-152.2%) of the baseline standing duration in the control group and intervention group respectively. The mean vertebral vTBMD in the intervention group increased by 8.16 mg/cm3, a 6% mean increase in vertebral vTBMD. There was no change in the mean proximal tibial vTBMD. The authors found that a longer period of standing in non-ambulant children with CP improves vertebral, but not proximal, tibial vTBMD. The authors concluded that such an intervention might reduce the risk of vertebral fractures, but is unlikely to reduce the risk of lower limb fractures in children with CP. In this study, all the children were involved in a standing program; there was no comparison between standing and non-standing participants.

Kecskemethy and colleagues (2008) acknowledged that despite widespread use, little is known about the actual weight borne while in a stander and the impact on BMD. They studied 6 males and 14 females in an attempt to quantify actual weight bearing while in two types of passive standers. The participants ranged in age from 6 to 21 years, had quadriplegic CP and were non-ambulatory. For each participant, weight bearing was monitored continuously during a routine 30-minute standing session using one of two standers. The total number of monitored sessions was 108. Right and left weight bearing was measured by the use of footplates interfaced with axial load cells. Weight borne during the 108 standing sessions ranged widely from 37% to 101%. Although mechanical loads are important for obtaining and maintaining bone mineralization, the findings of this study showed that skeletal loading is a very complex process not easily evaluated. The benefits of passive standing are dependent upon factors intrinsic to the particular person, (for example, physical status), as well as extrinsic factors, such as the device(s) used, positioning and measurements of clinical outcomes. The authors concluded that the quantity and quality of objective, scientific evidence demonstrating the benefits of weight bearing are varied and not always consistent, indicating the need for further studies to assess the benefits of weight bearing to include an assessment of actual weight borne.

Hough and colleagues (2010) systematically reviewed the published literature addressing the efficacy of interventions, (for example, medical and physical) to improve low bone mineral density (LBMD) in children and adolescents with CP. The authors found that the most promising interventions for decreased BMD were weight bearing and bisphosphonates. However, there are variations in bone development for pre- and post-pubescent individuals with CP. The cause of this variation is unknown and additional large RCTs are needed of both physical and medical approaches.

Other Conditions

In 2010, the Duchenne muscular dystrophy (DMD) Care Considerations Working Group, a group of experts selected by the Centers for Disease Control and Prevention (CDC) developed a comprehensive set of management strategies for DMD. The report notes that passive standing devices in late ambulatory and early non-ambulatory stages is necessary when there are no or mild hip, knee or ankle contractures. In addition, the continued use of a passive device or a power device into the late non-ambulatory stage if the contractures are not too severe and devices are tolerated was advocated. This recommendation is based upon collective judgment of the experts; there does not appear to be any published clinical trials which support this recommendation.

There have been two systematic reviews assessing the available evidence and providing recommendations for supported standing programs. A 2010 systematic review by Glickman and colleagues included 39 studies, 10 studies related to pediatric and 29 studies to adult populations. The majority of the studies included less than 50 participants and described or compared supported standing to another intervention or took measurement prior to and following the interventions. Studies were grouped based upon outcomes in BMD, cardiopulmonary function, muscle strength/function and range of motion (ROM). The authors noted that for both pediatric and adult populations, the available evidence moderately supports standing programs in BMD, ROM, spasticity and bowel function. For those with spinal cord injuries, there was a potentially negative cardiopulmonary side effect. The authors noted that conclusions were difficult to reach as the literature varied greatly in terms of design, intervention and outcome measures. The authors also noted that with the exception of ROM, perceived outcomes and benefits reported by therapists and users were not consistent with non-survey, literature-measured outcomes.

Paleg and colleagues (2013) addressed the use of standing support systems in the pediatric population. A total of 30 studies were reviewed, along with the authors' opinions, to obtain recommendations for minimal dosages needed to maintain body function and structures. These areas included, but were not limited to, mental, cardiovascular and respiratory, digestive and urinary functioning and structures of the bones. The evidence was evaluated and recommendations made based upon the Oxford Centre for Evidence-Based Medicine (CEBM) Levels of Evidence and the American Academy of Neurology (AAN) Levels of Evidence. Evidence levels range from the highest level (1: systematic review of randomized controlled trials) to lowest (5: expert opinion without critical appraisal). None of the studies were rated as level 1 evidence. A total of 20 of the studies were rated between levels of evidence 2-4. Those studies rated at level of evidence 2, were small studies, ranging from 5 to 97 participants.

Despite widespread clinical use, there is a paucity of consistent high quality studies or guidance based upon the evidence regarding the use of standing frames in those who require assistance to stand. The studies that do exist are small, or do not provide high quality, consistent evidence. Further studies are needed to adequately evaluate the potential benefits of standing devices in this clinical population.

Background/Overview

A sit-to-stand device allows the individual with upper body strength to achieve a standing position from a wheelchair without assistance. A sling is slipped behind the buttocks and hooked onto the frame of the standing device. The person's legs and feet are placed in supports on the frame. By using a pneumatic pump lever, the person lifts himself/herself to a standing position. A back support is rotated in place to support the individual's back.

A prone or supine stander is positioned next to the individual, usually next to a bed. The individual is either rolled or transferred to the device with the help of a sling lift. Once positioned on the device, the person's extremities are secured and the device is changed to a vertical (standing) position.

Standing frames can be categorized by types:

Definitions

Bone mineral density (BMD): Term used to describe the amount of calcium present in bone.

Duchenne muscular dystrophy (DMD): A type of muscular dystrophy which results in progressive muscle degeneration and weakness. Onset of symptoms is generally in early childhood between the ages of 3 to 5.

Prone: Lying with the front or face downward.

Reciprocal movement: Alternate movements of arms and legs seen in walking and other normal movements.

Supine: Lying on the back or having the face upward.

Coding

The following codes for treatments and procedures applicable to this document 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 are Investigational and Not Medically Necessary:

HCPCS 
E0637Combination sit to stand frame/table system, any size including pediatric, with seat lift feature, with or without wheels [when specified as standing system]
E0638Standing frame/table system, one position (e.g., upright, supine, or prone stander), any size including pediatric, with or without wheels
E0641Standing frame/table system, multi-position (e.g., three-way stander), any size including pediatric, with or without wheels
E0642Standing frame/table system, mobile (dynamic stander), any size including pediatric
E2230Manual wheelchair accessory, manual standing system
E2301Wheelchair accessory, power standing system, any type
  
ICD-10 Diagnosis 
 All diagnoses
  
References

Peer Reviewed Publications:

  1. Allison R, Dennett R. Pilot randomized controlled trial to assess the impact of additional supported standing practice on functional ability post stroke. Clin Rehabil. 2007; 21(7):614-619.
  2. Bagley P, Hudson M, Forster A, et al. A randomized trial evaluation of the Oswestry Standing Frame for patients after stroke. Clin Rehabil. 2005; 19(4):354-364.
  3. Bushby K, Finkel R, Birnkrant DJ, et al.; DMD Care Considerations Working Group. Diagnosis and management of Duchenne muscular dystrophy, part 1: diagnosis, and pharmacological and psychosocial management. Lancet Neurol. 2010a; 9(1):77-93.
  4. Bushby K, Finkel R, Birnkrant DJ, et al.; DMD Care Considerations Working Group. Diagnosis and management of Duchenne muscular dystrophy, part 2: implementation of multidisciplinary care. Lancet Neurol. 2010b; 9(2):177-189.
  5. Caulton JM, Ward KA, Alsop CW, et al. A randomized controlled trial of standing program on bone mineral density in non-ambulant children with cerebral palsy. Arch Dis Child. 2004; 89(2):131-135.
  6. Eng JJ, Levins SM, Townson AF, et al. Use of prolonged standing for individuals with spinal cord injuries. Phys Ther. 2001; 81(8):1392-1399.
  7. Glickman LB, Geigle PR, Paleg GS. A systematic review of supported standing programs. J Pediatr Rehabil Med. 2010; 3(3):197-213.
  8. Goktepe AS, Tugcu I, Yilmaz B, et al. Does standing protect bone density in patients with chronic spinal cord injury? J Spinal Cord Med. 2008; 31(2):197-201.
  9. Gudjonsdottir B, Stemmons Mercer V. Effects of a dynamic versus a static prone stander on bone mineral density and behavior in four children with severe cerebral palsy. Pediatr Phys Ther. 2002; 14(1):38-46.
  10. Hendrie WA, Watson MJ, McArthur MA. A pilot mixed methods investigation of the use of Oswestry standing frames in the homes of nine people with severe multiple sclerosis. Disabil Rehabil. 2015; 37(13):1178-1185.
  11. Hough J, Boyd R, Keating J. Systematic review of interventions for low bone mineral density in children with cerebral palsy. Pediatrics. 2010; 125(3):670-678.
  12. Kecskemethy H, Herman D, May R, et al. Quantifying weight bearing while in passive standers and a comparison of standers. Dev Med Child Neurol. 2008; 50(7):520-523.
  13. Kunkel CF, Scremin AM, Eisenberg B, et al. Effect of "standing" on spasticity, contracture, and osteoporosis in paralyzed males. Arch Phys Med Rehabil. 1993; 74(1):73-78.
  14. Kwok S, Harvey L, Glinsky J, et al. Does regular standing improve bowel function in people with spinal cord injury? A randomised crossover trial. Spinal Cord. 2015; 53(1):36-41.
  15. Macias-Merlo L, Bagur-Calafat C, Girabent-Farrés M, Stuberg WA. Standing programs to promote hip flexibility in children with spastic diplegic cerebral palsy. Pediatr Phys Ther. 2015; 27(3):243-249.
  16. Mergler S, Evenhuis H, Boot A, et al. Epidemiology of low bone mineral density and fractures in children with severe cerebral palsy: a systematic review. Develop Med & Child Neurol. 2009; 51(8):773-778.
  17. Paleg GS, Smith BA, Glickman LB. Systematic review and evidence-based clinical recommendations for dosing of pediatric supported standing programs. Pediatr Phys Ther. 2013; 25(3):232-247.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. Dicianno B, Morgan A, Lieberman J, et al. Rehabilitation Engineering & Assistive Technology Society of North America (RESNA) position on the application of wheelchair standing devices: 2013 current state of the literature. Available at: http://www.resna.org/sites/default/files/legacy/resources/position-papers/RESNAStandingPositionPaper_Dec2013.pdf. Accessed on September 9, 2015.
  2. Center for Medicare and Medicaid Services (CMS). National Coverage Determination for: Seat Lifts. NCD #280.4. Effective May 1, 1989. Available at: http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?
    NCDId=221&ncdver=1&SearchType=Advanced&CoverageSelection=Both&NCSelection=NCA%7cCAL%7cNCD%7cMEDCAC%7cTA%7cMCD&ArticleType=Ed%7cKey%7cSAD%7cFAQ&PolicyType=Final&s=---
    %7c5%7c6%7c66%7c67%7c9%7c38%7c63%7c41%7c64%7c65%7c44&KeyWord=seat+lift&KeyWordLookUp=Title&KeyWordSearchType=And&kq=true&bc=IAAAABAAAAAA&. Accessed on September 10, 2015.
  3. U.S. Food and Drug Administration 510(k) Premarket Notification Database. EasyStand Evolv (Ivacare Corp., Elyria, OH). No. K062402. Rockville, MD: FDA. September 21, 2006. Available at: http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K062402. Accessed on September 10, 2015.
  4. U.S. Food and Drug Administration 510(k) Premarket Notification Database. Rabbit Mobile Standing Frame. No. K030882. Rockville, MD: FDA. April 4, 2003. Available at: http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K030882. Accessed on September 10, 2015.
  5. U.S. Food and Drug Administration 510(k) Premarket Notification Database. Rifton Mobile Prone Standers™. No. K921894. Rockville, MD: FDA. May 26, 1992. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K921894. Accessed on September 10, 2015.
  6. Wang CH, Bonnemann CG, Rutkowski A, et al. Consensus statement on standard of care for congenital muscular dystrophies. J Child Neurol. 2010; 25(12):1559-1581.
Index

EasyStand Evolv
Rabbit Mobile Standing Frame
Rifton Standers
Standing Frames

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.

Document History
StatusDateAction
Reviewed11/05/2015Medical Policy & Technology Assessment Committee (MPTAC) review. Description, Rationale and Reference sections updated. Removed ICD-9 codes from Coding section.
Reviewed11/13/2014MPTAC review. Rationale and References sections updated.
Reviewed11/14/2013MPTAC review. References updated. Updated Coding section with 01/01/2014 HCPCS descriptor changes for E2301.
Reviewed11/08/2012MPTAC review. References updated.
Reviewed11/17/2011MPTAC review. Rationale, References updated. Updated Coding section with 01/01/2012 HCPCS descriptor revisions.
Reviewed11/18/2010MPTAC review.
Reviewed11/19/2009MPTAC review. References and Coding updated.
New11/20/2008MPTAC initial document development.