NCT05811494

Effectiveness of Multiple Robotic Gait-Devices for Improving Walking Ability in Subacute Stroke Patients

Effectiveness of Multiple Robotic Gait-Devices for Improving Walking Ability in Subacute Stroke Patients: a Randomized Controlled Trial

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Neuron, Spain · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to know the effectiveness of different robotic devices for gait rehabilitation in stroke patients

Detailed description

Subjects will attend the Neuron rehabilitation clinic on their own to begin a rehabilitation program. After being recruited for the study and signing informed consent the patient will be assessed with the Timed Up and Go Test and 10 Meter Walking Test, and it will be realized a spatio temporal variables analysis with baiobit system and a superficial Electomiografic activity analysis during gait with Noraxon system. Once the assessment is completed, the participant will receive the treatment assigned at his rehabilitation clinic. The patient will receive 30 minutes of robotic treatment with Lexi, Lokomat, C-Mill or the body-weight support treadmill and 15 minutes of overground walking training between 70-85% of HR max. Once the treatment period is over, after 25 sessions, the assessment will be carried out again, recording the initial tests in the same order by the same assessors.

Conditions

• Gait Disorders, Neurologic
• Stroke
• Walking

Interventions

Type	Name	Description
DEVICE	Lexo	Lexo is a Robot-Assited Gait device based on an end-effector system that supports the weight of the patient and help him to recover the walking function.
DEVICE	Lokomat	Lokomat is a Robot-Assited Gait device based on a fixed exoskeleton that supports the weight of the patient and help him to recover the walking function guiding the hips, knees and feet of the patient while walking.
DEVICE	C-Mill	C- Mill is a body weight support treadmill which includes virtual reality. I can provide feedback to the patient, assisting or hindering the gait task.
DEVICE	Body-weight support treadmill	Body-weight support treadmill group will receive the same time and intensity of training like the robotic groups but using the treadmill

Timeline

• Start date: 2023-03-15
• Primary completion: 2024-06-01
• Completion: 2024-08-01
• First posted: 2023-04-13
• Last updated: 2025-02-03

Locations

5 sites across 1 country: Spain