Clinical trial NCT04762940: INTENSIVE TREATMENT WITH ROBOTIC PLUS VIBRATION IN STROKE
Official title: EFFECTIVENESS OF INTENSIVE TREATMENT WITH ROBOTIC PLUS VIBRATION TO SENSITIVITY AND FUNCTIONALITY REHABILITATION IN STROKE PATIENTS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Activities, Motor
Quality of Life
Sensitivity
Upper Extremity Paresis
Keywords: Stroke
Rehabilitation
Upper limb
Sensitivity
Motor rehabilitation
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: The Amadeo® Manual Robotic System (Tyromotion GmbH, Graz, Austria) is designed for rehabilitative treatment of the hand and fingers providing robot-assisted exercise for the finger flexors and extensors. This system has a controlled position, active, active-assisted and passive exercise mode, it also allows isometric exercises with visual feedback provided during computerized games that emphasize flexion and extension. Another of the functions that this device presents and that differentiates it from other handheld robotic systems is its vibration function. Through sensors that are placed on the fingertips, providing a vibratory proprioceptive stimulus of different frequencies.

Currently, there are no published trials on the efficacy of the vibration of this device and its consequent improvement in the sensitivity and functionality of patients with hemiparesis after stroke. Investigations have been conducted in patients with peripheral lesions and in the healthy population. A preliminary study with monkeys demonstrated that the frequency of the vibration presents better results when the muscle stretch receptors are driven by a high frequency vibration, activating the neurons corresponding to the motor cortex and in the 3rd primary sensory area. More recent studies have shown the efficacy of focal vibratory stimulation applied to the wrist and forearm muscles, specifically the application to the tendon of the stimulated muscle.

Regarding the most appropriate form of stimulation, the most important determining factors to highlight are the frequency of application, the duration and intensity and the time of application. The mechanism of action of local muscle vibration is to stimulate various receptors. Meissner corpuscles respond best around 40 Hz, while Vater-Pacini corpuscles around 100 Hz. Together, they are also known as rapidly adapting cutaneous receptors. In contrast, Merkel-Ranvier cells and Ruffini corpuscles are called slow-adapting and classically described as sensitive to sustained pressure. That is why authors of different studies have focused on high frequency vibration of 300 Hz, for 30 minutes. 3 times per week. The duration of vibratory stimulation, different studies show the effects of vibration and changes in the cortex after performing the treatment constantly, for about ten days, intensively three to four days a week, observing long-term changes in terms on cortical excitability.

Detailed description: The rehabilitation of the stroke patient is an individual process, adapted to each type of patient, continuous and oriented by objectives whose main purpose is to treat and / or compensate for deficits and disability to achieve the maximum functional independence achievable in each case, facilitating independence and reintegration into the family, social and work environment. The stroke rehabilitation program is a complex process that requires a multidisciplinary approach to existing motor, sensory and / or neuropsychological deficiencies through re-education techniques based fundamentally on the phenomenon of neuronal plasticity and task-oriented rehabilitation.

There is evidence that supports the need to work on the intensity and repetition of motor skills in treatments to promote neuroplasticity and motor relearning. Considering the significant advances in information and communication technology (ICT) and more specifically the rapid development and deployment of technology, a number of recent systematic and non-systematic reviews highlight the increasing use of wearable devices to provide intensity to rehabilitation after of suffering a stroke including robotics, virtual reality, functional electrical stimulation (FES).

Robot-assisted therapy for post-stroke rehabilitation is relatively new as a complementary tool to physical therapy, through which patients practice their limb and paretic hand, resorting to or resisting the force offered by these robots.

The strongest point of these devices is the "attractive" variety of exercises that provide the user with great motivation, in addition to the "intensity" factor in the therapies. These factors allow for rehabilitation treatments with robotic technology, which cannot be achieved with any conventional rehabilitation therapy. The Amadeo® Manual Robotic System (Tyromotion GmbH, Graz, Austria) is designed for rehabilitative treatment of the hand and fingers providing robot-assisted exercise for the finger flexors and extensors. This system has a controlled position, active, active-assisted and passive exercise mode, it also allows isometric exercises with visual feedback provided during computerized games that emphasize flexion and extension.

Another of the functions that this device presents and that differentiates it from other handheld robotic systems is its vibration function. Through sensors that are placed on the fingertips, providing a vibratory proprioceptive stimulus of different frequencies.

Currently, there are no published trials on the efficacy of the vibration of this device and its consequent improvement in the sensitivity and functionality of patients with hemiparesis after stroke. Investigations have been conducted in patients with peripheral lesions and in the healthy population. A preliminary study with monkeys demonstrated that the frequency of the vibration presents better results when the muscle stretch receptors are driven by a high frequency vibration, activating the neurons corresponding to the motor cortex and in the 3rd primary sensory area. More recent studies have shown the efficacy of focal vibratory stimulation applied to the wrist and forearm muscles, specifically the application to the tendon of the stimulated muscle.

Regarding the most appropriate form of stimulation, the most important determining factors to highlight are the frequency of application, the duration and intensity and the time of application. The mechanism of action of local muscle vibration is to stimulate various receptors. Meissner corpuscles respond best around 40 Hz, while Vater-Pacini corpuscles around 100 Hz. Together, they are also known as rapidly adapting cutaneous receptors. In contrast, Merkel-Ranvier cells and Ruffini corpuscles are called slow-adapting and classically described as sensitive to sustained pressure. That is why authors of different studies have focused on high frequency vibration of 300 Hz, for 30 minutes. 3 times per week.

The duration of vibratory stimulation, different studies show the effects of vibration and changes in the cortex after performing the treatment constantly, for about ten days, intensively three to four days a week, observing long-term changes. term on cortical excitability. With regard to the evaluation of the different variables that are the subject of this study, a review of the tests has been carried out with more sensitive and reliable results at present. The Fugl Meyer Assessment Upper Extremity Scale (UE) continues to be one of the most commonly used and specific tests to assess motor and sensory impairment in stroke patient.

Since one of the main variables and object of measurement of the present study is sensitivity, it has been introduced, Semmes-Weinstein® Monofilaments is the most common and accurate instrument for sensory assessment. There are multiple scales to measure functionality such as FIM36 (Functional Independence Measure), FAM (Functional Assessment Measure), Barthel Index, however, the Motor Activity Log scale measures the functionality and motor performance of the most affected upper limb in a specific way, as well as its spontaneous use and integration in quantity and quality in the performance of Activities of Daily Living.

Stroke impact Scale (SIS) is a specific questionnaire for patients with brain damage and measures the impact it has had on their quality of life. SIS version 3.0 contains 8 domains related to hand function, strength, activities of daily living, communication, emotion, memory, and thinking. The SIS is a valid and reliable measure for a diverse group of patients after suffering a stroke.

The present study aims to determine, in stroke patients with left hemiparesis, the efficacy of intensive vibration therapy treatment with the Amadeo® robotic system, focusing on assessing sensitivity, integration of the affected upper limb and functionality, as well such as the improvement in the quality of life in the execution of their Activities of daily living in comparison with those patients who do not receive intensive vibration treatment but do perform upper limb treatment with the Amadeo® robotic system.

We present a randomized controlled trial to compare the improvement in sensitivity, the integration of the hemibody and the functionality in a sample of people who have suffered a stroke with left hemiparesis and receive intensive vibratory treatment, through the Amadeo robotic system ® compared to another population with the same characteristics that does not receive this vibration therapy, although they do perform robotic treatment without vibration.

It will be conducted at the "Los Madroños" hospital and Clínica NEURON (Madrid, Spain).

Inclusion criteria:

* Age: people aged between 30 and 80 years.
* Diagnosis: stroke in the right hemisphere.
* Right-handed.
* Present hemiparesis or left hemiplegia with paralysis / paresis in his affected hand.
* People with sensitivity alterations as a result of stroke.
* Evolution: subacute patients (from three months to one year, and who at the same time meet the subacute criteria of the IMSERSO document of the model of care for people with brain damage, as well as chronic patients (after one year, and who meet the chronicity criteria of the IMSERSO document of the model of care for people with brain damage).
* People without other concomitant pathologies that affect mobility and / or sensitivity
* The acceptance and signing of the informed consent by the user.
* Present a score equal to or greater than 24 points in the Mini-Mntal State Examination (MMSE).
* Patients can be admitted or outpatient as long as they meet the above criteria and belong to the advanced neurorehabilitation unit.

Exclusion criteria:

* Patients with Aphasia and / or Apraxia.
* Patients with serious difficulties in communication.
* Patients who do not present limitation of mobility and / or sensitivity.
* Other concomitant diseases.
* Diagnosis: left or posterior hemisphere stroke.
* Present a score of less than 24 points on the MMSE.
* Age over 80 years and under 30 years.
* The non-acceptance and signing of the informed consent by the subject.
* Evolution: acute patients less than three months of evolution.

Patients eligible to receive treatment will be consecutively randomized into two groups, those who receive robotic therapy with vibration and movement, and those who receive only vibration.

Outcomes:

* Clinical information: patient's sociodemographic data and anamnesis, the neurological examination and the different functional and sensitivity scales of which are:
* Semmes-Weinstein (SW) ® monofilaments for sensitivity assessment
* Fugl Meyer Assessment scale for the upper limb.
* Motor Activity Log (MAL).
* Stroke Impacte Scale (SIS).
* Questionnaire of satisfaction with technology. (based on the principles of the Likert scale)

Follow up:

One month after the post-treatment evaluation, the research team will re-evaluate, administering all the tests from the previous evaluations except for the technology satisfaction questionnaire. It will be carried out in the Advanced Neurorehabilitation Unit and exclusively to the population of the experimental group to see if the results obtained in the treatment are maintained over time.

Intervention:

The patients will be referred by the team made up of rehabilitation doctors and specialized neurologists from Hospital Los Madroños and Clínica NEURON and will receive treatment in its Advanced Neurorehabilitation Units:

* In the "experimental" group, sessions will be held three times a week with 24 sessions (a month and a half of treatment), with a vibration duration of approximately 20 minutes with a high vibration frequency. The intensity and timing of this treatment has been based on previous protocols, as previously justified in this project. Vibration therapy, with proprioceptive stimuli through sensors placed on the distal phalanges of the fingers, modulation from lower to higher frequency being possible
* In the "control" group, they will receive the same 24 robotics sessions three times a week for movement, but without specifically receiving vibration therapy. Therapy will be based on movements.
* Robotic treatment:

Assisted therapy: It allows to carry out the movement by force of the fingers themselves, compensating the range of movement that the user does not perform.

Interactive therapy: Allows to carry out active finger movement oriented to tasks or games. These can be configured to adapt them as much as possible to the capabilities of the user.

Eligibility criteria: Inclusion Criteria:

* Age: people aged between 30 and 80 years.
* Diagnosis: stroke in the right hemisphere.
* Right-handed.
* Present hemiparesis or left hemiplegia with paralysis / paresis in his affected hand.
* People with sensitivity alterations as a result of stroke.
* Evolution: subacute patients (from three months to one year, and who at the same time meet the subacute criteria of the IMSERSO document of the model of care for people with brain damage, as well as chronic patients (after one year, and who meet the chronicity criteria of the IMSERSO document of the model of care for people with brain damage).
* People without other concomitant pathologies that affect mobility and / or sensitivity
* The acceptance and signing of the informed consent by the user.
* Present a score equal to or greater than 24 points in the Mini-Mntal State Examination (MMSE).

  * Patients can be admitted or outpatient as long as they meet the above criteria and belong to the advanced neurorehabilitation unit.

Exclusion Criteria:

* Patients with Aphasia and / or Apraxia.
* Patients with serious difficulties in communication.
* Patients who do not present limitation of mobility and / or sensitivity.
* Other concomitant diseases.
* Diagnosis: left or posterior hemisphere stroke.
* Scores less than 24 points on the MMSE.
* Age over 80 years and under 30 years.
* The non-acceptance and signing of the informed consent by the subject.
* Evolution: acute patients less than three months of evolution.

Primary outcomes:
measure: Change from Fugl Meyer Assessment scale for the upper limb (change): Pre-treatment
timeFrame: Pre-treatment
measure: Change from Fugl Meyer Assessment scale for the upper limb at 1,5 months (change): Post-treatment period
timeFrame: Post-treatment (1,5 months)
Secondary outcomes:
measure: Semmes-Weinstein ® monofilaments for sensitivity assessment
timeFrame: One month and a half
measure: Motor Activity Log
timeFrame: One month and a half
measure: Stroke Impacte Scale.
timeFrame: One month and a half
measure: Questionnaire of satisfaction with technology
timeFrame: One month and a half
Other outcomes:
Locations:
city: Alcorcón
country: Spain
facility: Universidad Rey Juan Carlos
state: Madrid
Study officials:
References:
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