Clinical trial NCT05811494: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Gait Disorders, Neurologic
Stroke
Walking
Keywords: Gait-Devices
Robotics
Stroke
Gait
Lead sponsor: Neuron, Spain
Sponsor class: OTHER
First posted: 2023-04-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in gait speed
timeFrame: Change from Baseline in gait speed at 4 weeks
Secondary outcomes:
measure: Gait ratio
timeFrame: Change from Baseline in gait ratio at 4 weeks
measure: Double stance time during the gait cycle
timeFrame: Change from Baseline in double stance time during the gait cycle at 4 weeks
measure: Percentage of time in stance phase during the gait cycle
timeFrame: Change from Baseline in percentage of time in stance phase during the gait cycle at 4 weeks
measure: Maximal Voluntary Contraction (MVC) of the rectus femurs
timeFrame: Change from Baseline in MVC of the rectus femurs at 4 weeks
measure: Co-contraction index
timeFrame: Change from Baseline in co-contraction index at 4 weeks
measure: Changue in balance
timeFrame: Change from Baseline in balance at 4 weeks
measure: Change in risk of falling
timeFrame: Change from Baseline in risk of falling at 4 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Neuron Chamberí
city: Madrid
country: Spain
facility: Neuron Mercedes
city: Madrid
country: Spain
facility: Neuron Habana
city: Madrid
country: Spain
facility: Neuron Madrid Rio
city: Valencia
country: Spain
facility: Neuron Valencia
Study officials:
References: