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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-15

Study Completion Date

2024-08-01

Brief Summary

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

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Detailed Description

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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

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Gait Disorders, Neurologic Stroke Walking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

There will be three groups of robotic treatment. One of them will receive the walking training with an End-effector Device (LEXO), another with a fixed exoskeleton (Lokomat), and the last one with a Body-Weight Support Treadmill system with Augmented Reality (C-Mill). Theree will be an experimental group which will receive the walking rehabilitation by using a Treadmill with Body-Weight Support

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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End-Effector walking training

Participants in the End-effector group will receive one session per day over 4 weeks of Physical Therapy. This therapy will consist in 30 minutes of Lexo training adjusting the assistance/resistance of the device for working in 14-17 in the Borg scale and 70-85% HRmax of the patient, assessed with the Tanaka formula (208-(0,7+Age)) and with the correction of 10 beats less if the patient is taking ß-blockers.

Group Type EXPERIMENTAL

Lexo

Intervention Type DEVICE

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.

Fixed Exoskeleton walking training

Participants in the fixed-exoskeleton group will receive one session per day over 4 weeks of Physical Therapy. This therapy will consist in 30 minutes of Lokomat training adjusting the assistance/resistance of the device for working in 14-17 in the Borg scale and 70-85% HRmax of the patient, assessed with the Tanaka formula (208-(0,7+Age)) and with the correction of 10 beats less if the patient is taking ß-blockers.

Group Type EXPERIMENTAL

Lokomat

Intervention Type DEVICE

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.

Body-Weight Support treadmill training with augmented reality

Participants in the Body-Weight Support treadmill training with augmented reality group will receive one session per day over 4 weeks of Physical Therapy. This therapy will consist in 30 minutes of C-Mill training adjusting the assistance/resistance of the device for working in 14-17 in the Borg scale and 70-85% HRmax of the patient, assessed with the Tanaka formula (208-(0,7+Age)) and with the correction of 10 beats less if the patient is taking ß-blockers.

Group Type EXPERIMENTAL

C-Mill

Intervention Type DEVICE

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.

Body-Weight Support treadmill training

Participants in the Body-Weight Support treadmill training group will receive one session per day over 4 weeks of Physical Therapy. This therapy will consist in 30 minutes of body-weight support treadmill training adjusting the assistance/resistance of the device for working in 14-17 in the Borg scale and 70-85% HRmax of the patient, assessed with the Tanaka formula (208-(0,7+Age)) and with the correction of 10 beats less if the patient is taking ß-blockers.

Group Type ACTIVE_COMPARATOR

Body-weight support treadmill

Intervention Type DEVICE

Body-weight support treadmill group will receive the same time and intensity of training like the robotic groups but using the treadmill

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Having suffered an ischaemic or haemorrhagic stroke with less than 6 months of evolution at the start of the study
* Presenting gait deficits compatible with a level between 2 and 3 of the functional category of gait (FAC)
* More than 20 seconds in the Time Up and Go test
* Less than 3 points on the Reisberg Global Deterioration Scale (GDS-R).

Exclusion Criteria

* Presenting any type of specific contraindication to use the robotic device to be used with respect to their group. Thus, those patients who present a limitation in the range of movement in the hip of more than 0º of extension and 40º of flexion, in the knee of less than 30º of flexion and in the ankle of less than 0º of dorsal flexion will not be able to participate in the study.
* Lower limb spasticity greater than 3 on the modified Asworth scale
* Unable to maintain an assisted standing position for more than 5 minutes
* Unable to understand simple commands

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No