Effects of Robotic Versus Manually-Assisted Locomotor Training for Individuals With Incomplete Spinal Cord Injury

NCT00127439 | Completed Results DMC

• 1 other identifier: B4024-I
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to collect data comparing two means of providing locomotor training: manual and robotic and the possible differential effects it may have on walking ability for persons with spinal cord injury (SCI).

Conditions

Spinal Cord Injuries

Keywords

Ambulatory Disability; Disability Ambulation; Locomotion Disorders; Motor Activity; Rehabilitation; Spinal Cord Injury

Outcome Measures

Primary Outcomes (9)

• Self Selected Velocity on Treadmill

  Subjects walk on a treadmill with overhead safety mounted to laboratory ceiling while wearing a harness. Treadmill speeds adjusted to lower than overground walking speeds and adjusted to patient reaches a comfortable speed.

  12 weeks

• Stepping: Foot Trajectory Toe-Off

  Foot angle in a global reference frame at the start of swing phase during treadmill walking at self-selected speed. The kinematic outcomes were first standardized as deviations from control subjects who walk at similar speed (i.e., deviation from the control mean divided by SD among control). Stepping was quantified by the change in orientation of the foot angle (in a global reference frame) from the beginning to the end of the swing phase (i.e., foot-off to foot-down). The values will be identified from the processed 3-D kinematics for each walking cycle and average across steps.

  12 weeks

• Stepping: Foot Trajectory Toe-off % Cycle

  The outcome measure is the percentage of the gait cycle (%) for the occurrence of toe off. Foot trajectory toe-off was identified as indicated in the prior primary outcome (#2). The occurrence of toe-off was then identified relative to the percent of a complete gait cycle and thus the end point of the stance component of the gait cycle and the point of initiation for the swing component of the gait cycle. This outcome is reported in per cent of gait cycle.

  12 weeks

• Foot Trajectory Initial Contact

  Foot trajectory initial contact is the foot angle in a global reference frame at the end of swing (start of stance phase) during treadmill walking at self-selected speed when the foot contacts the ground (i.e. heel strike, foot contact, initial contact). The kinematic outcomes were first standardized as deviations from control subjects who walk at similar speed (i.e. deviation from the control mean divided by the SD among control). Foot trajectory initial contact (heel strike) was quantified by the orientation of the foot angle (in a global reference frame) at foot down (initial contact or heel strike). The values will be identified from the process 3-D kinematics for each walking cycle and averaged across steps. The outcome measurement is in degrees.

  12 weeks

• Foot Trajectory Range (Toe Off to Heel Strike)

  Range of foot trajectory from toe off to heel strike in degrees. The kinematic outcomes were first standardized as deviations from control subjects who walk at similar speed (i.e., deviation from the control mean divided by SD among control).

  12 weeks

• Propulsion: Propulsive Impulse

  Push-off force at toe off in N-s during treadmill stepping

  12 weeks

• Kinematics: Minimum Thigh Angle

  Greatest thigh angle for hip flexion during stepping

  12 weeks

• Kinematics: Minimum Hip Angle - Extension

  Hip angle at maximal hip extension during stepping

  12 weeks

• Kinematics: Trunk Angle Mid-Stance

  Trunk Angle Mid-Stance - position in degrees

  12 weeks

Study Arms (2)

Robotic Assisted Locomotor Training

EXPERIMENTAL

A robotic stepping device in concert with a body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. The robotic device provides the appropriate kinematics associated with standing and stepping.

Other: Robotic Assisted Locomotor Training

Manually Assisted Locomotor Training

EXPERIMENTAL

A body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. Therapists and trainers promote the appropriate kinematics associated with standing and stepping.

Procedure: Manually Assisted Locomotor Training

Interventions

Manually Assisted Locomotor Training PROCEDURE

The total program is 45 sessions, 5x/week with total locomotor training (LT) duration of 30 stepping minutes/day. 1) BWS is initiated at 40% and gradually decreasing to 0%, 2) treadmill speed is set at normal walking speeds and increased as tolerated, and 3) manual assistance given when the subject is unable to independently step or control upright posture, and decreased as participant progresses. Trainers assist via verbal cues and manual assistance to achieve good stepping. The goal for endurance is 20 mins of continuous, independent, coordinated stepping on the treadmill at 0% BWS. Participants are encouraged to assist and/or independently maintain an upright posture, weight shift onto the loaded limb, flex or extend their legs, and to swing their arms in coordination with the legs.

Also known as: manually assisted body-weight supported treadmill training

Manually Assisted Locomotor Training

Robotic Assisted Locomotor Training OTHER

The total program is 45 sessions, 5x/week with total locomotor training (LT) duration of 30 stepping minutes/day. 1) BWS is initiated at 40% and gradually decreasing to 0%, 2) treadmill speed is set at normal walking speeds and increased as tolerated, and 3) manual assistance given when the subject is unable to independently step or control upright posture, and decreased as participant progresses. Trainers assist via verbal cues and manual assistance to achieve good stepping. The goal for endurance is 20 mins of continuous, independent, coordinated stepping on the treadmill at 0% BWS. Participants are encouraged to assist and/or independently maintain an upright posture, weight shift onto the loaded limb, flex or extend their legs, and to swing their arms in coordination with the legs.

Also known as: robotic assisted body-weight supported treadmill training

Robotic Assisted Locomotor Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults at least 18 years of age
• Spinal cord injury (SCO) at least 6 months since injury
• Motor I-SCI, upper motor neuron lesion only at cervical or thoracic levels
• A diagnosis of first time SCI including etiology from trauma, vascular, or orthopedic pathology
• SCI as defined by the American ASIA Impairment Scale categories C or D
• Medically stable condition that is asymptomatic for bladder infection, decubiti, osteoporosis, cardiopulmonary disease, pain, contractures or other significant medical complications that would prohibit or interfere with testing of walking function and training or alter compliance with the training protocol
• Documented medical approval from the participant's personal physician verifying the participant's medical status at time of enrollment
• Ability to walk a minimum of 30 feet with or without an assistive device, independently or with minimal assistance
• Over ground gait speed \< 0.8 m/s
• Persons using anti-spasticity medication must maintain stable medication dosage during the study
• Able to give informed consent

You may not qualify if:

• Current participation in a rehabilitation program/research protocol that could interfere or influence the outcome measures of the current study
• History of congenital SCI (e.g. myelomeningocele, intraspinal neoplasm, Friedreich's ataxia) or other degenerative spinal disorders (e.g. spinocerebellar degeneration, syringomyelia) that may complicate the protocol
• Inappropriate or unsafe fit of the harness or robotic trainer due to the participant's body size and/or joint contractures or severe spasticity that would prohibit the safe provision of either training modality

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

North Florida/South Georgia Veterans Health System

Gainesville, Florida, 32608, United States

Location

Related Publications (7)

• Behrman AL, Harkema SJ. Locomotor training after human spinal cord injury: a series of case studies. Phys Ther. 2000 Jul;80(7):688-700.

  PMID: 10869131 BACKGROUND

• Barbeau H, Norman K, Fung J, Visintin M, Ladouceur M. Does neurorehabilitation play a role in the recovery of walking in neurological populations? Ann N Y Acad Sci. 1998 Nov 16;860:377-92. doi: 10.1111/j.1749-6632.1998.tb09063.x.

  PMID: 9928326 BACKGROUND

• Hesse S, Uhlenbrock D. A mechanized gait trainer for restoration of gait. J Rehabil Res Dev. 2000 Nov-Dec;37(6):701-8.

  PMID: 11321006 BACKGROUND

• Colombo G, Joerg M, Schreier R, Dietz V. Treadmill training of paraplegic patients using a robotic orthosis. J Rehabil Res Dev. 2000 Nov-Dec;37(6):693-700.

  PMID: 11321005 BACKGROUND

• Hornby TG, Zemon DH, Campbell D. Robotic-assisted, body-weight-supported treadmill training in individuals following motor incomplete spinal cord injury. Phys Ther. 2005 Jan;85(1):52-66.

  PMID: 15623362 BACKGROUND

• Trimble MH, Behrman AL, Flynn SM, Thigpen MT, Thompson FJ. Acute effects of locomotor training on overground walking speed and H-reflex modulation in individuals with incomplete spinal cord injury. J Spinal Cord Med. 2001 Summer;24(2):74-80. doi: 10.1080/10790268.2001.11753558.

  PMID: 11587422 BACKGROUND

• Day KV, Kautz SA, Wu SS, Suter SP, Behrman AL. Foot placement variability as a walking balance mechanism post-spinal cord injury. Clin Biomech (Bristol). 2012 Feb;27(2):145-50. doi: 10.1016/j.clinbiomech.2011.09.001. Epub 2011 Oct 14.

  PMID: 22000699 RESULT

Related Links

• Click here for more information about this study: Differential Effects of Robotic vs. Manually-Assisted Locomotor Training

MeSH Terms

Conditions

Spinal Cord Injuries; Motor Activity

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Behavior

Limitations and Caveats

Data for two subjects was incomplete during outcome measures acquisition, interpretable and removed from data analysis.Two subjects did not complete. An n=24 was anticipated; an original N=19 enrolled, the group sizes decreased to 8 and 7.

Results Point of Contact

• Title: Andrea L. Behrman, PhD, PT
• Organization: University of Louisville

andreabehrman@catholichealth.net

502-582-7451

Study Officials

• Andrea Behrman, PT PhD

  North Florida/South Georgia Veterans Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2005
• First Posted: August 5, 2005
• Study Start: June 1, 2005
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: January 24, 2018
• Results First Posted: January 24, 2018

Record last verified: 2018-01

Locations

US (1)