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

NCT05811494 | Withdrawn

• 1 other identifier: ALC001NR003
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Gait Disorders, Neurologic; Stroke; Walking

Keywords

Gait-Devices; Robotics; Stroke; Gait

Outcome Measures

Primary Outcomes (1)

• Change in gait speed

  The velocity at which the patient is able to cover 6 meters at comfortable speed. It will be measured with the 10 Meter walking test in which the evaluator tells the patient to walk over 10 meters and takes the time required to cover the 6 meters in the middle, leaving the 2 initial and final meter for acceleration and deceleration.

  Change from Baseline in gait speed at 4 weeks

Secondary Outcomes (7)

• Gait ratio

  Change from Baseline in gait ratio at 4 weeks

• Double stance time during the gait cycle

  Change from Baseline in double stance time during the gait cycle at 4 weeks

• Percentage of time in stance phase during the gait cycle

  Change from Baseline in percentage of time in stance phase during the gait cycle at 4 weeks

• Maximal Voluntary Contraction (MVC) of the rectus femurs

  Change from Baseline in MVC of the rectus femurs at 4 weeks

• Co-contraction index

  Change from Baseline in co-contraction index at 4 weeks

Study Arms (4)

End-Effector walking training

EXPERIMENTAL

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.

Device: Lexo

Fixed Exoskeleton walking training

EXPERIMENTAL

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.

Device: Lokomat

Body-Weight Support treadmill training with augmented reality

EXPERIMENTAL

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.

Device: C-Mill

Body-Weight Support treadmill training

ACTIVE COMPARATOR

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.

Device: Body-weight support treadmill

Interventions

Lexo 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.

End-Effector walking training

Lokomat 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.

Fixed Exoskeleton walking training

C-Mill 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 with augmented reality

Body-weight support treadmill DEVICE

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

Body-Weight Support treadmill training

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Neuron, Spain: lead

Study Sites (5)

Neuron Chamberí

Madrid, Madrid, 28003, Spain

Location

Neuron Mercedes

Madrid, Madrid, 28022, Spain

Location

Neuron Habana

Madrid, Madrid, 28023, Spain

Location

Neuron Madrid Rio

Madrid, Madrid, 28045, Spain

Location

Neuron Valencia

Valencia, 46023, Spain

Location

MeSH Terms

Conditions

Gait Disorders, Neurologic; Stroke

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinator in Research Department

Model Details: 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

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: April 13, 2023
• Study Start: March 15, 2023
• Primary Completion: June 1, 2024
• Study Completion: August 1, 2024
• Last Updated: February 3, 2025

Record last verified: 2025-01

Locations

ES (5)