CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 44 enrolled
Drug / intervention
30 minutes Lokomat +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT02749357
NCT02749357N/ACompleted

Effect of Different Programs of Robotic Assisted Gait Training in Individuals With Chronic Motor Incomplete Spinal Cord Injury.

Instituto Nacional de Rehabilitacion·interventional·Posted Apr 25, 2016·Updated Aug 25, 2021

In Brief

A clinical study evaluating 30 minutes Lokomat and 60 minutes Lokomat for Spinal Cord Injuries. Completed, enrolled 44 participants across 1 site.

Detailed Summary

INTRODUCTION: The ability to move and transfer own body in an effective manner, is frequently affected in people with a spinal cord injury with a negative impact in mood and quality of life, in such a way, that achieving an effective locomotion, is one of the main objectives in the rehabilitation program in a spinal cord injured patient. There are different modalities of locomotion training in spinal cord injury, being the robotic orthosis among them, and offering until now, positive outcomes. However there´s still a lack of evidence of the optimal training characteristics, in order to establish the best time, number of sessions, and progression scheme. For these reasons, establishing the effects of different locomotion training programs will provide the necessary data in order to develop an effective training program for the maximum benefit of the patient. OBJECTIVE To determine the effect of different training programs with robotic gait orthosis for patients with chronic motor incomplete spinal cord injury (SCI) (American Spinal Injury Association Impairment Scale (AIS) C / D) in short and long term. METHODS AND DESIGN. The design of the study consists on a randomized, blinded to the observer, clinical trial. Patients from the National Institute of Rehabilitation (INR) with spinal cord injury, AIS C and D, with at least 6 months of evolution, and who are able to walk with or without gait auxiliary, will be eligible. Informed consent will be obtained from all subjects prior to participation. Patients will be randomly assigned to either one of the two different training groups: intervention or control group. The control group will be submitted to training sessions of 30 minutes, and the intervention group will have training sessions of 60 minutes. Both groups will receive a training period of six weeks, five days a week. Throughout the training period, gait assessments with the GaitRite instrument, will be performed, and repeated at 6 and 12 months after completion of the training as part of follow up. The data obtained from the GaitRite will be compared within each group, in order to determine which type of training is more effective Statistical analysis will be performed using SPSS, considering all P \< 0.05 as statistically significant.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesMexico

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedApr 25, 2016
Enrollment StartMay 1, 2016
Primary CompletionJun 1, 2021
Study CompletionAug 1, 2021
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 10.2 years ago

Interventions

30 minutes Lokomatdevice

30 training sessions in robotic orthosis with duration of 30 or 60 minutes during 6 weeks, duration of 30 minutes. The initial training speed will be the comfortable one for each patient, as assessed by Swinnen (20). The training progression will consist in a 10% weekly increase in speed, and a 5% weekly reduction of partial weight support.

60 minutes Lokomatdevice

30 training sessions in robotic orthosis with duration of 30 or 60 minutes during 6 weeks, duration of 60 minutes.