INTENSIVE TREATMENT WITH ROBOTIC PLUS VIBRATION IN STROKE

NCT04762940 | Unknown

• 1 other identifier: URJC-MADROÑOS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Activities, Motor; Quality of Life; Sensitivity; Upper Extremity Paresis

Keywords

Stroke; Rehabilitation; Upper limb; Sensitivity; Motor rehabilitation

Outcome Measures

Primary Outcomes (2)

• Change from Fugl Meyer Assessment scale for the upper limb (change): Pre-treatment

  Motor Function

  Pre-treatment

• Change from Fugl Meyer Assessment scale for the upper limb at 1,5 months (change): Post-treatment period

  Motor Function

  Post-treatment (1,5 months)

Secondary Outcomes (4)

• Semmes-Weinstein ® monofilaments for sensitivity assessment

  One month and a half

• Motor Activity Log

  One month and a half

• Stroke Impacte Scale.

  One month and a half

• Questionnaire of satisfaction with technology

  One month and a half

Study Arms (2)

Control group

ACTIVE COMPARATOR

They will receive 24 robotics sessions with Amadeo robot three times a week for movement, but without specifically receiving vibration therapy.

Device: Robotic

Experimental group

EXPERIMENTAL

They will recieve three times a week with 24 sessions plus vibration duration of approximately 20 minutes with a high vibration frequency. Vibration therapy, with proprioceptive stimuli through sensors placed on the distal phalanges of the fingers, modulation from lower to higher frequency being possible will be conducted prior to robotic treatments with Amadeo.

Device: Robotic; Device: Vibration

Interventions

Robotic DEVICE

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. Robotic treatment will be conducted three times a week with 24 sessions (a month and a half of treatment) with 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; and interactive therapy: it 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.

Control group; Experimental group

Vibration DEVICE

Vibration duration of approximately 20 minutes with a high vibration frequency will be conducted prior to robotic treatment. 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 (high frequency vibration of 300 Hz).

Experimental group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Rey Juan Carlos: lead

Study Sites (1)

Universidad Rey Juan Carlos

Alcorcón, Madrid, 28922, Spain

Location

Related Publications (1)

• 1. OMS. Who Steps Stroke Manual. En: Manual de la OMS para la vigilancia de accidentes cerebrovasculares. OMS 2006; p.1-5. 2. Pinedo S, De la Villa FM. Complicaciones en el paciente hemipléjico durante el primer año tras el ictus. Rev Neurol 2001; 32: 206-9. 3. Steultjens E, Dekker J, Bouter L, Van des Nes J, Van den Ende C, Landi F et al. Occupational Therapy for Stroke Patients: A systematic Review. Occupational Therapy for Stroke Patients: When, Where and How? Stroke 2003; 34; 676-87. 4. Brea A, Laclaustra M, Martorell E, Pedragosa À. Epidemiología de la enfermedad vascular cerebral en España. Clin e Investig en Arterioscler. 2013;25(5):211-7. 5. Cuadrado Á. Rehabilitación del ACV: evaluación, pronóstico y tratamiento Rehabilitation of the stroke: evaluation, prognosis and treatment. GaliciaclinicaInfo 2009;70(3):1-40. 6. Larsen LH, Zibrandtsen IC, Wienecke T, Kjaer TW, Christensen MS, Nielsen JB, et al. Corticomuscular coherence in the acute and subacute phase after stroke. Clin Neurophysiol 2017;128(11):2217-26. 7. Murphy MA, Resteghini C, Feys P, Lamers I. An overview of systematic reviews on upper extremity outcome measures after stroke. BMC Neurol. 2015 Mar 11;15(1). 8. Wu CY, Huang PC, Chen YT, Lin KC, Yang HW. Effects of mirror therapy on motor and sensory recovery in chronic stroke: a randomized controlled trial. Arch Phys Med Rehabil. 2013; 94:1023-30. 9. Invernizzi M, Negrini S, Carda S, Lanzotti L, Cisari C, Baricich A. The value of adding mirror therapy for upper limb motor recovery of subacute stroke patients: a randomized controlled trial. Eur J Phys Rehabil Med. 2013; 49:311-7. 10. Levin MF, Weiss PL, Keshner EA. Emergence of virtual reality as a tool for upper limb rehabilitation: incorporation of motor control and motor learning principles. Phys Ther. 2015; 95:415-25. 11. Sanchez Blanco. Monografico sobre Rehabilitacion de pacientes tras accidente cerebrovascular. Rehabilitacion (Madr). 2000; 36: 395-18. 19 12. Escuela Leeanne M. Carey de Ciencias de la Salud del Comportamiento, Universidad La Trobe, Victoria, Australia). 13. Sánchez-Blanco I, López de Munaín L, Ochoa-Sangrador C. Clasificación pronóstica de pacientes hemipléjicos: valor pronóstico en rehabilitación. Mapfre Med 1996; 7:187-96. 14. Sanchez Blanco. Predictive Model of functional independence in stroke patients admitted to a rehabilitation programme. Clin Rehabil. 1999; 13:464-75. 15. Subramanian S, Knaut LA, Beaudoin C, McFayden BJ, Feldman AG, Levin MF. Virtual reality environments for post-stroke arm rehabilitation. J Neuroeng Rehabil 2007; 4: 20. 16. Schmidth AR, Lee DT. Motor control and learning. A behavioural emphasis. Champaign. Human Kinetics; 1982. 17. Cano de la Cuerda R, Collado S. Neurorrehabilitacion. Métodos específicos de valoración y tratamiento. Madrid. Editorial Médica Panamericana; 2012: 89-139. 18. .Halsband U, Lange RK. Motor learning in man: a review of functional and clinical studies. J Physiol Paris. 2006; 99:414-24. 19. Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011; 377:1693-702. 20. Park Y, Chang M, Kim KM, An DH. The effects of mirror therapy with tasks on upper extremity function and self-care in stroke patients. J Phys Ther Sci. 2015; 27:1499-501. 21. ZanYue et al. Hand Rehabilitation Robotics on Poststroke Motor Recovery. Behavioural Neurology Volume 2017. 22. Stein J, Bishop L, Gillen G, Helbok R. Robot-assisted exercise for hand weakness after stroke. A pilot study. American Journal of Physical Medicine & Rehabilitation. 2011; 90(11):887-894. 23. Celadon N, Dosen S, Binder I, Ariano P, Farina D. Proportional estimation of finger movements from high-density surface electromyography. Journal of Neuroengineering and Rehabilitation. 2016; 13(1):73. 24. Gandolfi M, Valè N et al. Effects of High-intensity Robot-assisted Hand Training on Upper Limb Recovery and Muscle Activity in Individuals With Multiple Sclerosis: A Randomized, Controlled, SingleBlinded Trial. Front. Neurol. 2018 Oct 24; 9:905. 25. Flor H. Cortical reorganisation and chronic pain: implications for rehabilitation. J Rehabil Med 2003; 41: 66-72. 26. Kishor L, Abigail W, Viswanathan R, John G. et al. Application of vibration to wrist and hand skin affects fingertip tactile sensation. Physiol Rep, 3 (7), 2015. 27. Collins DF, Refshauge KM, Todd G, Gandevia SC. Cutaneous receptors contribute to kinesthesia at the index finger, elbow, and knee. J Neurophysiol 2005; 94:1699-706. 11.

  BACKGROUND

MeSH Terms

Conditions

Stroke; Motor Activity; Hypersensitivity; Paresis

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Roberto Cano de la Cuerda, PhD

CONTACT

914888674; roberto.cano@urjc.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessments will be made by researches blinded for the patient´s group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: February 12, 2021
• First Posted: February 21, 2021
• Study Start: March 15, 2021
• Primary Completion: May 15, 2021
• Study Completion: June 15, 2021
• Last Updated: February 21, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)