Robotic Gait Training in Spinal Cord Injury

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.

Conditions

• Spinal Cord Injuries

Interventions

DEVICE

30 minutes Lokomat

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.

DEVICE

60 minutes Lokomat

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

Sponsors & Collaborators

• National Council of Science and Technology, Mexico

  collaborator OTHER

• Instituto Nacional de Rehabilitacion

  lead OTHER_GOV

Principal Investigators

• Jimena Quinzaños, MSc · Instituto Nacional de Rehabilitacion

• Ivett Quiñones, PHD · Instituto Nacional de Rehabilitacion

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-05-31

Primary Completion

2021-06-30

Completion

2021-08-31

Countries

• Mexico

Study Locations