- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00127439
Effects of Robotic Versus Manually-Assisted Locomotor Training for Individuals With Incomplete Spinal Cord Injury (DE)
Differential Effects of Robotic vs. Manually-Assisted Locomotor Training
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Spinal cord injury (SCI) is one of the most disabling health problems facing adults today, with one of the consequences often being inability to walk or difficulty walking. Recent studies suggest that intensive step training on a treadmill using body-weight support (BWS) and manual assistance that provides repetitive task-specific sensory cues to the neural axis can improve the recovery of walking for persons with incomplete SCI. More recently, robotics have been developed as an alternative to manually-assisted training. Robotic-assisted training may allow for increased intensity of training, improve the reproducibility and consistency of training, and reduce the personnel needed to implement the training. However, the effects of robotic-assisted training compared to manually-assisted training are not known. An improved understanding of these differential effects and the mechanisms of improvement in walking can facilitate continued advances in evidenced-based practice of neuro-rehabilitation, therefore improving the treatment of persons with SCI.
The primary objective of this project is to assess and compare the effects of robotic-assisted versus manually-assisted locomotor training (LT) using the body-weight support (BWS) on sub-tasks of walking. Specifically, we believe that at least four sub-tasks of walking are differentially affected by the robotic-assisted training when compared to manually-assisted training (propulsion, transition from stance to step, stepping, and equilibrium). The investigators hypothesize that robotic-assisted training will have a greater effect on improving propulsion, transition and equilibrium. The effect of these two modalities on adaptability, a fifth sub-task of walking, is unclear; therefore, a development component of the pilot project will involve establishing a quantitative measure of adaptability and assessing differential effects of training. Participants will be randomized to one of two training groups: robotic-assisted or manually-assisted, and evaluated for performance on sub-tasks of walking.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Florida
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Gainesville, Florida, États-Unis, 32608
- North Florida/South Georgia Veterans Health System
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Robotic Assisted Locomotor Training
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.
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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.
Autres noms:
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Expérimental: Manually Assisted Locomotor Training
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.
|
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.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Self Selected Velocity on Treadmill
Délai: 12 weeks
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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.
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12 weeks
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Stepping: Foot Trajectory Toe-Off
Délai: 12 weeks
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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.
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12 weeks
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Stepping: Foot Trajectory Toe-off % Cycle
Délai: 12 weeks
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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.
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12 weeks
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Foot Trajectory Initial Contact
Délai: 12 weeks
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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.
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12 weeks
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Foot Trajectory Range (Toe Off to Heel Strike)
Délai: 12 weeks
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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).
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12 weeks
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Propulsion: Propulsive Impulse
Délai: 12 weeks
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Push-off force at toe off in N-s during treadmill stepping
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12 weeks
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Kinematics: Minimum Thigh Angle
Délai: 12 weeks
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Greatest thigh angle for hip flexion during stepping
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12 weeks
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Kinematics: Minimum Hip Angle - Extension
Délai: 12 weeks
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Hip angle at maximal hip extension during stepping
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12 weeks
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Kinematics: Trunk Angle Mid-Stance
Délai: 12 weeks
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Trunk Angle Mid-Stance - position in degrees
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12 weeks
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Andrea Behrman, PT PhD, North Florida/South Georgia Veterans Health System
Publications et liens utiles
Publications générales
- Behrman AL, Harkema SJ. Locomotor training after human spinal cord injury: a series of case studies. Phys Ther. 2000 Jul;80(7):688-700.
- 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.
- Hesse S, Uhlenbrock D. A mechanized gait trainer for restoration of gait. J Rehabil Res Dev. 2000 Nov-Dec;37(6):701-8.
- 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.
- 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.
- 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.
- 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, Avon). 2012 Feb;27(2):145-50. doi: 10.1016/j.clinbiomech.2011.09.001. Epub 2011 Oct 14.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- B4024-I
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Informations sur les médicaments et les dispositifs, documents d'étude
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