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Guideline Summary
Guideline Title
Best evidence statement (BESt). Intensive partial body weight supported treadmill training.
Bibliographic Source(s)
Cincinnati Children's Hospital Medical Center. Best evidence statement (BESt). Intensive partial body weight supported treadmill training. Cincinnati (OH): Cincinnati Children's Hospital Medical Center; 2010 Oct. 10 p. [32 references]
Guideline Status

This is the current release of the guideline.

Scope

Disease/Condition(s)

Neurological disorders such as cerebral palsy (CP), spinal cord injury (SCI), and acquired brain injury (ABI)

Guideline Category
Treatment
Clinical Specialty
Family Practice
Internal Medicine
Neurology
Pediatrics
Physical Medicine and Rehabilitation
Intended Users
Advanced Practice Nurses
Nurses
Occupational Therapists
Physical Therapists
Physician Assistants
Physicians
Guideline Objective(s)

To evaluate if intensive partial body weight supported treadmill training (PBWSTT), robotic or manual, compared to other activities, is more effective in improving function, specifically gait and/or gross motor skills, in individuals with neurological disorders such as cerebral palsy (CP), spinal cord injury (SCI), and acquired brain injury (ABI)

Target Population

Inclusion

  • Children, adolescents, and young adults up to 21 years of age
  • Individuals who:
    • Meet the equipment specifications

      Note: For Lokomat® training distance between the knee joint line and the greater trochanter must be between 21 cm and 47 cm

    • Demonstrate emerging gait and/or gross motor skills
    • Follow commands and
    • Indicate readiness to improve their health through participation in this intensive program
  • Individuals with:
    • Cerebral palsy (CP): Gross Motor Function Classification System (GMFCS) level II – IV (see Appendix 1 in the original guideline document)
    • Spinal cord injury (SCI): Intact quadriceps and Achilles tendon reflex; American Spinal Injury Association (ASIA) C & D (chronic, greater than 1 year post injury); ASIA B, C, or D (acute, less than 1 year post injury)
    • Acquired brain injury (ABI)
    • Other non progressive neurologic disorders

Exclusion

  • Individuals with spinal instability, large disc bulge/rupture
  • Individuals with severe orthostatic hypotension that limits time in weight bearing
  • For those with SCI, high resting diastolic blood pressure (BP) that interferes with patients ability to exercise safely

    Note: >90mmHg is considered an exclusion by Hocoma for the Lokomat

  • Machine-assisted respiration (ventilator dependent)
  • Individuals not able to tolerate upright position for at least 30 minutes
  • Individuals with severe osteoporosis and/or lower extremity/pelvic/rib fracture
  • Individuals with uncontrolled seizures that pose a safety risk and limit ability to participate in program
  • Individuals for whom bed rest or immobilization has been prescribed because of osteomyelitis or other inflammatory and/or infectious diseases
  • When loading of the hip, pelvic, abdominal, and/or chest region is prohibited
Interventions and Practices Considered

Partial body weight supported treadmill training (PBWSTT) including robotic and manual

Major Outcomes Considered

Functional skills, specifically gait and/or gross motor skills

Methodology

Methods Used to Collect/Select the Evidence
Hand-searches of Published Literature (Primary Sources)
Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence

Search Strategy

  1. Databases

    Search Terms: Partial body weight supported treadmill training, Partial body weight treadmill training, Partial body support treadmill training, Harness, Litegait®, Walkable, Lokomat®, Robotic driven gait orthosis, Treadmill training, Suspended, Task specific training, Mobility, Gross motor, Quality of life, Cardio-respiratory, Strength, Independence, Activities of daily living, Self care, Gait, Postural control

  1. Limits and Filters: English, humans
  2. Additional articles: from reference lists
Number of Source Documents

Not stated

Methods Used to Assess the Quality and Strength of the Evidence
Weighting According to a Rating Scheme (Scheme Given)
Rating Scheme for the Strength of the Evidence

Table of Evidence Levels

Quality Level Definition
1a† or 1b† Systematic review, meta-analysis, or meta-synthesis of multiple studies
2a or 2b Best study design for domain
3a or 3b Fair study design for domain
4a or 4b Weak study design for domain
5 Other: General review, expert opinion, case report, consensus report, or guideline

†a = good quality study; b = lesser quality study

Methods Used to Analyze the Evidence
Review of Published Meta-Analyses
Systematic Review
Description of the Methods Used to Analyze the Evidence

Not stated

Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations

Not stated

Rating Scheme for the Strength of the Recommendations

Table of Recommendation Strength

Strength Definition
"Strongly recommended" There is consensus that benefits clearly outweigh risks and burdens (or vice-versa for negative recommendations).
"Recommended" There is consensus that benefits are closely balanced with risks and burdens.
No recommendation made There is a lack of consensus to direct development of a recommendation.
Dimensions: In determining the strength of a recommendation, the development group makes a considered judgment in a consensus process that incorporates critically appraised evidence, clinical experience, and other dimensions as listed below.
  1. Grade of the Body of Evidence
  2. Safety/Harm
  3. Health benefit to the patients (direct benefit)
  4. Burden to patient of adherence to recommendation (cost, hassle, discomfort, pain, motivation, ability to adhere, time)
  5. Cost-effectiveness to healthcare system (balance of cost/savings of resources, staff time, and supplies based on published studies or onsite analysis)
  6. Directness (the extent to which the body of evidence directly answers the clinical question [population/problem, intervention, comparison, outcome])
  7. Impact on morbidity/mortality or quality of life
Cost Analysis

A formal cost analysis was not performed and published cost analyses were not reviewed.

Method of Guideline Validation
Peer Review
Description of Method of Guideline Validation

Reviewed against quality criteria by two independent reviewers.

Recommendations

Major Recommendations

The strength of the recommendation (strongly recommended, recommended, and no recommendation) and the quality of evidence (1a-5) are defined at the end of the "Major Recommendations" field.

  1. It is recommended that partial body weight supported treadmill training (PBWSTT) be considered as a physical therapy treatment intervention in a clinical setting for individuals who show potential to improve gait and/or gross motor skills with the diagnoses of:
    • Cerebral palsy (CP) (Mattern-Baxter 2009 [1b]; Fiss & Effgen, 2006 [1b]; Meyer-Heim et al., 2009 [3a]; Damiano, 2009 [5]; Hocoma, "Recommendations for clinical practice: pediatric," 2006 [5]; Local Consensus [5])
    • Spinal cord injury (SCI) (Damiano & DeJong, 2009 [1a]; Mehrholz, Kugler, & Pohl, 2008 [1a]; Hocoma, "Recommendations for clinical practice: pediatric," 2006 [5]; Hocoma, "Recommendations for clinical practice: spinal cord injury," 2006 [5]; Local Consensus [5])
    • Acquired brain injury (ABI) (Hocoma, "Recommendations for clinical practice: pediatric," 2006 [5]; Local Consensus [5]) or
    • Other non-progressive neurologic disorders (Damiano & DeJong, 2009 [1a]; Fiss & Effgen, 2006 [1b]; Tuckey & Greenwood, 2004 [5]; Local Consensus [5])

    Note: Treatment can be initiated after a trial has been undertaken to assess fit and tolerance to the equipment (Local Consensus [5]).

  1. It is recommended that the percentage of body weight support given to the patient is individualized to the patient's needs and determined by clinical judgment of the therapist. The goal is to minimize the amount of body weight support given to the patient while maintaining an erect posture and optimal gait pattern (Damiano & DeJong, 2009 [1a]; Mattern-Baxter, 2009 [1b]; Marshall et al., 2007 [1b]; Local Consensus [5]).
  2. It is recommended that treadmill speed targets functional gait speed but may need to be adjusted to optimize the stepping pattern (Damiano & DeJong, 2009 [1a]; Mattern-Baxter, 2009 [1b]).
  3. It is recommended that the intensity of PBWSTT be delivered as follows:
    • Frequency: 2 or more times per week (Damiano & DeJong, 2009 [1a]; Mattern-Baxter, 2009 [1b]; Meyer-Heim et al., 2009 [3a]; Trahan & Malouin, 2002 [4b]; Hocoma, "Recommendations for clinical practice: pediatric," 2006 [5], Hocoma, "Recommendations for clinical practice: spinal cord injury," 2006 [5]; Local Consensus [5]).
    • Session length: goal of 30 minutes of direct walking time on the treadmill (Damiano & DeJong, 2009 [1a]; Mattern-Baxter, 2009 [1b]; Meyer-Heim et al., 2009 [3a]; Hocoma, "Recommendations for clinical practice: pediatric," 2006 [5]; Hocoma, "Recommendations for clinical practice: spinal cord injury," 2006 [5]; Local Consensus [5]).

      Note: Total session length will be longer to include set up, getting on and off equipment, and carry over to over ground training (Hocoma, "Recommendations for clinical practice: pediatric," 2006 [5]; Hocoma, "Recommendations for clinical practice: spinal cord injury," [5]; Local Consensus [5]).

    • Length of episode of care: 15 to 20 sessions (Mattern-Baxter, 2009 [1b]; Meyer-Heim et al., 2009 [3a]; Hocoma, "Recommendations for clinical practice: pediatric," 2006 [5]; Hocoma, "Recommendations for clinical practice: spinal cord injury," [5]; Local Consensus [5]).

      Note 1: If the patient is not demonstrating progress towards goals the episode of care may be discontinued. (Damiano & DeJong, 2009 [1a]; Local Consensus [5]).

      Note 2: Plateaus need to be assessed on an individual basis since progress does not always occur in a linear fashion and may occur in increments (Damiano & DeJong, 2009 [1a]).

    • Additional episodes: For acute conditions the length of episode of care may be extended when the patient is continuing to make progress during a time of rapid recovery as determined by appropriate tests and measures (Local Consensus [5]). For chronic conditions an episode of intensive PBWSTT may be repeated every 6-12 months if follow-up assessments indicate that the individual gained and maintained new gait and/or gross motor skills (Local Consensus [5]).

      Note: After an episode of care is completed a break from traditional therapy services may be indicated to "allow practice and generalization" (Schertz & Gordon, 2009 [5]) of skills (Trahan & Malouin, 2002 [4b]; Schertz & Gordon, 2009 [5]; Local Consensus [5]).

  1. It is recommended that a home program be developed and provided to the family with emphasis on skill carryover with suggested activities that target enhanced community participation in daily activity. (Local Consensus [5]).
  2. It is recommended that the decision to use robotic versus manual PBWSTT be determined by clinical judgment of the therapist in agreement with child and family preferences, taking into consideration the following:
    • Over ground ambulation
    • Trunk control
    • Motor control
    • Spasticity

    (Local Consensus [5])

    Robotic

    Note 1: Robotic PBWSTT may be utilized with individuals who require external assistance to manage many aspects of their gait cycle (Local Consensus [5]).

    Note 2: Benefits of robotic PBWSTT are that it provides greater and more precise repetitions of a typical gait cycle and utilizes fewer staff resources (Fiss & Effgen, 2006 [1b]; Meyer-Heim et al., 2009 [3a]; Local Consensus [5]).

    Note 3: Individuals with increased muscle tone that interferes with functioning of the machine may not be eligible for robotic PBWSTT. (Local Consensus [5])

    Manual

    Note 1: Manual PBWSTT may be utilized with higher functioning individuals who demonstrate some independence with active stepping for community and household ambulation (Local Consensus [5]).

    Note 2: A benefit of manual PBWSTT is that it affords the individual opportunities to self manage aspects of their gait cycle (Fiss & Effgen, 2006 [1b]; Local Consensus [5]).

  1. It is recommended that regular skin checks are performed before and after the intervention by the caregiver or therapist to monitor skin integrity (Local Consensus [5]).
  2. It is recommended that clinicians receive specialized training in PBWSTT prior to providing this intervention. (Mutlu, Krosschell, & Spira, 2009 [1b]; Local Consensus [5]).
  3. It is recommended that gait speed, walking endurance, gross motor skills, strength (myometry) and occupational performance be evaluated a) before starting the intensive PBWSTT program, b) immediately after completing and c) 6 weeks after completing the intensive PBWSTT program to determine the effects of the intervention. (Schertz & Gordon, 2009 [5]; Local Consensus [5]).

    Note 1: Recommended Outcome Measures to evaluate treatment efficacy

    1. Walking velocity: 10 meter walk/run test (Thompson et al., 2008 [2b])
    2. Walking endurance: 6 minute walk test (Thompson et al., 2008 [2b], ATS Committee on Proficiency Standards for Clinical Pulmonary Function, 2002 [5])
    3. Gross motor function measure: GMFM 66 (Russell et al., 2000 [2b])
    4. Canadian Occupational Performance Measure (COPM) (Law et al., 1990 [5])

    Note 2: Optional Outcome Measures to evaluate treatment efficacy

    1. Childhood Assessment of Participation and Enjoyment (CAPE) (King et al., 2007 [2a])
    2. Cerebral Palsy Quality of Life (CPQOL) (Waters et al., 2007 [2a])
    3. Functional Independence Measure for Children (WeeFIM) (Uniform Data System for Medical Rehabilitation, 2006 [5])
    4. Pediatric Evaluation of Disability Inventory (PEDI) (Haley et al., 1992 [5])

Definitions:

Table of Evidence Levels

Quality Level Definition
1a† or 1b† Systematic review, meta-analysis, or meta-synthesis of multiple studies
2a or 2b Best study design for domain
3a or 3b Fair study design for domain
4a or 4b Weak study design for domain
5 Other: General review, expert opinion, case report, consensus report, or guideline

†a = good quality study; b = lesser quality study

Table of Recommendation Strength

Strength Definition
"Strongly recommended" There is consensus that benefits clearly outweigh risks and burdens (or vice-versa for negative recommendations).
"Recommended" There is consensus that benefits are closely balanced with risks and burdens.
No recommendation made There is a lack of consensus to direct development of a recommendation.
Dimensions: In determining the strength of a recommendation, the development group makes a considered judgment in a consensus process that incorporates critically appraised evidence, clinical experience, and other dimensions as listed below.
  1. Grade of the Body of Evidence
  2. Safety/Harm
  3. Health benefit to the patients (direct benefit)
  4. Burden to patient of adherence to recommendation (cost, hassle, discomfort, pain, motivation, ability to adhere, time)
  5. Cost-effectiveness to healthcare system (balance of cost/savings of resources, staff time, and supplies based on published studies or onsite analysis)
  6. Directness (the extent to which the body of evidence directly answers the clinical question [population/problem, intervention, comparison, outcome])
  7. Impact on morbidity/mortality or quality of life
Clinical Algorithm(s)

None provided

Evidence Supporting the Recommendations

References Supporting the Recommendations
Type of Evidence Supporting the Recommendations

The type of supporting evidence is identified and graded for each recommendation (see the "Major Recommendations" field).

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits

Functional Outcomes

When designed by a licensed physical therapist in conjunction with caregiver input, the hypothesized outcomes of partial body weight supported treadmill training (PBWSTT) may include improved:

  • Gait speed
  • Gait endurance
  • Walking function
  • Weight acceptance during transfers and
  • Motor skills

Benefits

  • PBWSTT provides a safe environment to practice walking
  • PBWSTT decreases demands on therapist, makes repetitive training more feasible, increases safety of standing and ambulation training and decreases the work necessary by one or more therapists
Potential Harms

Considerations/Side Effects/Risks

  • Decreased sensation could result in excessive shearing on skin causing breakdown without patient knowledge
  • Strenuous program with high level of commitment required
  • Manual partial body weight supported treadmill training (PBWSTT) has been purported to pose risk of injury to the therapist

Precautions

  • Inappropriate or unsafe fit of the harness/equipment due to the participant's body size
  • Open skin lesion in area of contact with equipment (cuff, harness support, robotic orthosis)
  • Conditions that result in compromised skin integrity
  • Skeletal dysplasia and individuals with a major difference (>2 cm) in leg length may not be accommodated by robotic legs (this only applies to the Lokomat®)
  • Bracing of spinal column or lower extremity (LE) that would preclude fit into the Driven Gait Orthosis or harness
  • Severely fixed contractures
  • Cardiac abnormalities resulting in activity restrictions
  • Severe vascular disorders of the lower limbs resulting in changes in sensation or compromised circulation
  • Uncooperative or self-aggressive behavior
  • Patients with long term access ports (colostomy, gastro-intestinal tube, peripherally inserted central catheter, etc.) where the PBWSTT equipment may disrupt position or increase pressure at site

Adverse Events

  • Mutlu and Mattern-Baxter comment that no adverse events have been reported and the treatment does not appear to be harmful
  • Friction associated skin breakdown can be observed

Qualifying Statements

Qualifying Statements

This Best Evidence Statement addresses only key points of care for the target population; it is not intended to be a comprehensive practice guideline. These recommendations result from review of literature and practices current at the time of their formulation. This Best Evidence Statement does not preclude using care modalities proven efficacious in studies published subsequent to the current revision of this document. This document is not intended to impose standards of care preventing selective variances from the recommendations to meet the specific and unique requirements of individual patients. Adherence to this Statement is voluntary. The clinician in light of the individual circumstances presented by the patient must make the ultimate judgment regarding the priority of any specific procedure.

Implementation of the Guideline

Description of Implementation Strategy

An implementation strategy was not provided.

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need
Getting Better
IOM Domain
Effectiveness

Identifying Information and Availability

Bibliographic Source(s)
Cincinnati Children's Hospital Medical Center. Best evidence statement (BESt). Intensive partial body weight supported treadmill training. Cincinnati (OH): Cincinnati Children's Hospital Medical Center; 2010 Oct. 10 p. [32 references]
Adaptation

Not applicable: The guideline was not adapted from another source.

Date Released
2010 Oct
Guideline Developer(s)
Cincinnati Children's Hospital Medical Center - Hospital/Medical Center
Source(s) of Funding

Cincinnati Children's Hospital Medical Center

Guideline Committee

Not stated

Composition of Group That Authored the Guideline

Best Evidence Statement (BESt) Development Team: Amy Bailes, PT, MS, PCS, Team Leader, Division of Occupational Therapy and Physical Therapy; Kelly Bonarrigo, PT, DPT, Division of Occupational Therapy and Physical Therapy; Jenny Schmit, PT, DPT, PhD, Division of Occupational Therapy and Physical Therapy

Senior Clinical Director: Rebecca D. Reder, OTD, OTR/L, Division of Occupational Therapy and Physical Therapy

Ad Hoc Member: Stacey Maignan, PT, MPT, Division of Occupational Therapy and Physical Therapy

Division of Health Policy & Clinical Effectiveness Support: Karen Vonderhaar, MS, RN, Guidelines Program Administrator; Alison Kissling, BA, MLIS, Pratt Library

Cincinnati Children's Hospital Medical Center (CCHMC) Reviewer(s): Jilda Vargus-Adams, MD, MSc, Pediatric Physiatrist, Assistant Professor, University of Cincinnati College of Medicine

Ad hoc Advisors: Michelle Kiger, OTR/L, Division of Occupational Therapy and Physical Therapy; Mary Gilene, MBA, Division of Occupational Therapy and Physical Therapy

Financial Disclosures/Conflicts of Interest

Conflict of interest declarations were completed by members of the Best Evidence Statement (BESt) development team and none were found.

Guideline Status

This is the current release of the guideline.

Guideline Availability

Electronic copies: Available from the Cincinnati Children's Hospital Medical Center External Web Site Policy.

Print copies: For information regarding the full-text guideline, print copies, or evidence-based practice support services contact the Cincinnati Children's Hospital Medical Center Health James M. Anderson Center for Health Systems Excellence at EBDMInfo@cchmc.org.

Availability of Companion Documents

The following are available:

Print copies: For information regarding the full-text guideline, print copies, or evidence-based practice support services contact the Cincinnati Children's Hospital Medical Center Health James M. Anderson Center for Health Systems Excellence at EBDMInfo@cchmc.org.

Patient Resources

None available

NGC Status

This NGC summary was completed by ECRI Institute on March 16, 2011.

Copyright Statement

This NGC summary is based on the original full-text guideline, which is subject to the following copyright restrictions:

Copies of this Cincinnati Children's Hospital Medical Center (CCHMC) External Web Site Policy Best Evidence Statement (BESt) are available online and may be distributed by any organization for the global purpose of improving child health outcomes. Examples of approved uses of the BESt include the following:

  • Copies may be provided to anyone involved in the organization's process for developing and implementing evidence based care;
  • Hyperlinks to the CCHMC website may be placed on the organization's website;
  • The BESt may be adopted or adapted for use within the organization, provided that CCHMC receives appropriate attribution on all written or electronic documents; and
  • Copies may be provided to patients and the clinicians who manage their care.

Notification of CCHMC at EBDMInfo@cchmc.org for any BESt adopted, adapted, implemented or hyperlinked by the by the organization is appreciated.

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