Back to resultsEffectiveness of Multiple Robotic Gait-Devices for Improving Walking Ability in Subacute Stroke Patients
Primary Purpose
Gait Disorders, Neurologic, Stroke, Walking
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Lexo
Lokomat
C-Mill
Body-weight support treadmill
Sponsored by
About this trial
This is an interventional treatment trial for Gait Disorders, Neurologic focused on measuring Gait-Devices, Robotics, Stroke, Gait
Eligibility Criteria
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
Sites / Locations
- Neuron Chamberí
- Neuron MercedesRecruiting
- Neuron Habana
- Neuron Madrid Rio
- Neuron Valencia
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
End-Effector walking training
Fixed Exoskeleton walking training
Body-Weight Support treadmill training with augmented reality
Body-Weight Support treadmill training
Arm Description
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.
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.
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Gait ratio
This refers to the relationship between stride length and gait cadence during walking, and is expressed in mm/step/minute. It represents the tendency of motor stride optimisation to minimise the metabolic cost during walking and has normal values of 6 mm/step/minute in women and 7 mm/step/minute in men with a standard deviation of ±08%. It will be measured using Biobit device.
Double stance time during the gait cycle
Double stance during gait occurs when both feet are in contact with the ground at the same time. It will be measured using Biobit device
Percentage of time in stance phase during the gait cycle
The stance phase is the part of each gait cycle that begins at heel strike and ends at toe-off. The stance time is therefore the time between the initial contact and the last contact of a single stride. It will be measured using Biobit device
Maximal Voluntary Contraction (MVC) of the rectus femurs
Motor unit recruitment capacity of the rectus femoris muscle during maximal contraction. An electrode will be placed in the middle third of the rectus femoris muscle parallel to the muscle fibres and in line with the midline of the patella as described by SENIAM. To carry out the measurement, the patient will be placed in a seated position with the knee at 90º of flexion and in contact with the edge of the stretcher. The patient will be asked to do 2 sets of 10 repetitions at 50% of the MVC as a warm-up and then, after 1 minute rest, the patient will be asked to extend the knee as hard and fast as possible for 3 seconds. This process shall be repeated twice more, leaving 1 minute rest between each contraction, and the measurement with the highest average score in those 3 seconds shall be taken. It will be measured using Noraxon EMG software
Co-contraction index
It is an indirect measure of muscle metabolic cost during walking. Thus, using the formula provided by Falconer et al ,ICC=(2×EMG antagonist)/((EMG antagonist+EMG agonist)) ×100, and applying it during the different phases of gait (double stance, monopodal stance, second double stance and swing phase), we obtain the ICC of the muscles responsible for flexion and flexion, second double stance and swing phase), we will obtain the ICC of the musculature in charge of knee flexion-extension (rectus femoris and semitendinosus) and of the musculature in charge of plantar and dorsal flexion of the ankle (tibialis anterior and medial gastrocnemius). It will be measured using Norton EMG software
Changue in balance
Balance has been described as the capacity of controlling the center of pressures while realizing any task. It will be measured with the Berg Balance Scale
Change in risk of falling
A fall is defined as an event in which an adult unintentionally loses balance and descends to the ground or other lower surface. It is not related to a medical incident or other overwhelming external force. On the other hand, risk was defined by the World Health Organisation (WHO) as the probability that an undesirable event with respect to an individual's health status will occur. It will be measured by Timed Up and Go Test
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05811494
Brief Title
Effectiveness of Multiple Robotic Gait-Devices for Improving Walking Ability in Subacute Stroke Patients
Official Title
Effectiveness of Multiple Robotic Gait-Devices for Improving Walking Ability in Subacute Stroke Patients: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2023 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Neuron, Spain
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gait Disorders, Neurologic, Stroke, Walking
Keywords
Gait-Devices, Robotics, Stroke, Gait
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
Investigator
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
End-Effector walking training
Arm Type
Experimental
Arm Description
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.
Arm Title
Fixed Exoskeleton walking training
Arm Type
Experimental
Arm Description
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.
Arm Title
Body-Weight Support treadmill training with augmented reality
Arm Type
Experimental
Arm Description
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.
Arm Title
Body-Weight Support treadmill training
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Lexo
Intervention Description
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
Intervention Name(s)
Lokomat
Intervention Description
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
Intervention Name(s)
C-Mill
Intervention Description
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
Intervention Name(s)
Body-weight support treadmill
Intervention Description
Body-weight support treadmill group will receive the same time and intensity of training like the robotic groups but using the treadmill
Primary Outcome Measure Information:
Title
Change in gait speed
Description
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.
Time Frame
Change from Baseline in gait speed at 4 weeks
Secondary Outcome Measure Information:
Title
Gait ratio
Description
This refers to the relationship between stride length and gait cadence during walking, and is expressed in mm/step/minute. It represents the tendency of motor stride optimisation to minimise the metabolic cost during walking and has normal values of 6 mm/step/minute in women and 7 mm/step/minute in men with a standard deviation of ±08%. It will be measured using Biobit device.
Time Frame
Change from Baseline in gait ratio at 4 weeks
Title
Double stance time during the gait cycle
Description
Double stance during gait occurs when both feet are in contact with the ground at the same time. It will be measured using Biobit device
Time Frame
Change from Baseline in double stance time during the gait cycle at 4 weeks
Title
Percentage of time in stance phase during the gait cycle
Description
The stance phase is the part of each gait cycle that begins at heel strike and ends at toe-off. The stance time is therefore the time between the initial contact and the last contact of a single stride. It will be measured using Biobit device
Time Frame
Change from Baseline in percentage of time in stance phase during the gait cycle at 4 weeks
Title
Maximal Voluntary Contraction (MVC) of the rectus femurs
Description
Motor unit recruitment capacity of the rectus femoris muscle during maximal contraction. An electrode will be placed in the middle third of the rectus femoris muscle parallel to the muscle fibres and in line with the midline of the patella as described by SENIAM. To carry out the measurement, the patient will be placed in a seated position with the knee at 90º of flexion and in contact with the edge of the stretcher. The patient will be asked to do 2 sets of 10 repetitions at 50% of the MVC as a warm-up and then, after 1 minute rest, the patient will be asked to extend the knee as hard and fast as possible for 3 seconds. This process shall be repeated twice more, leaving 1 minute rest between each contraction, and the measurement with the highest average score in those 3 seconds shall be taken. It will be measured using Noraxon EMG software
Time Frame
Change from Baseline in MVC of the rectus femurs at 4 weeks
Title
Co-contraction index
Description
It is an indirect measure of muscle metabolic cost during walking. Thus, using the formula provided by Falconer et al ,ICC=(2×EMG antagonist)/((EMG antagonist+EMG agonist)) ×100, and applying it during the different phases of gait (double stance, monopodal stance, second double stance and swing phase), we obtain the ICC of the muscles responsible for flexion and flexion, second double stance and swing phase), we will obtain the ICC of the musculature in charge of knee flexion-extension (rectus femoris and semitendinosus) and of the musculature in charge of plantar and dorsal flexion of the ankle (tibialis anterior and medial gastrocnemius). It will be measured using Norton EMG software
Time Frame
Change from Baseline in co-contraction index at 4 weeks
Title
Changue in balance
Description
Balance has been described as the capacity of controlling the center of pressures while realizing any task. It will be measured with the Berg Balance Scale
Time Frame
Change from Baseline in balance at 4 weeks
Title
Change in risk of falling
Description
A fall is defined as an event in which an adult unintentionally loses balance and descends to the ground or other lower surface. It is not related to a medical incident or other overwhelming external force. On the other hand, risk was defined by the World Health Organisation (WHO) as the probability that an undesirable event with respect to an individual's health status will occur. It will be measured by Timed Up and Go Test
Time Frame
Change from Baseline in risk of falling at 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alfredo Lerín, PhD Student
Phone
+34620187457
Email
alfre_lerin@hotmail.com
Facility Information:
Facility Name
Neuron Chamberí
City
Madrid
ZIP/Postal Code
28003
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irene García Pascual
Facility Name
Neuron Mercedes
City
Madrid
ZIP/Postal Code
28022
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mónica Grifol Domingo
Facility Name
Neuron Habana
City
Madrid
ZIP/Postal Code
28023
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enrique Carrasco González
Facility Name
Neuron Madrid Rio
City
Madrid
ZIP/Postal Code
28045
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alfredo Lerín Calvo
Phone
620187457
Email
alfre_lerin@hotmail.com
Facility Name
Neuron Valencia
City
Valencia
ZIP/Postal Code
46023
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Álvaro Entrena Casas
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Multiple Robotic Gait-Devices for Improving Walking Ability in Subacute Stroke Patients
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