CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 19 enrolled
Drug / intervention
Manually Assisted Locomotor Training +1 moreprocedure
Likely dose
45 sessions of 30-minute stepping training (treadmill with progressive body-weight support reduction from 40% to 0%, treadmill speed increased as tolerated), 5 days/weekAI-extracted
Key inclusion· 8
  • ✓Adults aged ≥18 years
  • ✓Spinal cord injury at least 6 months since injury
  • ✓Motor incomplete SCI (ASIA C or D) with upper motor neuron lesion at cervical or thoracic levels
  • ✓SCI from trauma, vascular, or orthopedic pathology (first-time SCI)
Key exclusion· 3
  • ✕Current participation in another rehabilitation program or research protocol that could interfere with outcome measures
  • ✕History of congenital SCI (myelomeningocele, intraspinal neoplasm, Friedreich's ataxia) or degenerative spinal disorders (spinocerebellar degeneration, syringomyelia)
  • ✕Inappropriate or unsafe fit of harness or robotic trainer due to body size, joint contractures, or severe spasticity prohibiting safe training

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00127439
NCT00127439N/ACompleted
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Differential Effects of Robotic vs. Manually-Assisted Locomotor Training

VA Office of Research and Development·interventional·Posted Aug 5, 2005·Updated Jan 24, 2018

In Brief

A clinical study evaluating Manually Assisted Locomotor Training and Robotic Assisted Locomotor Training for Spinal Cord Injuries. Completed, enrolled 19 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSpinal Cord Injuries
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 5, 2005
Enrollment StartJun 1, 2005
Primary CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 20.9 years ago

Interventions

Manually Assisted Locomotor Trainingprocedure

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.

Robotic Assisted Locomotor Trainingother

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.