Exoskeleton Research: Myoelectric Orthosis for Rehab of Severe Chronic Arm Motor Deficits

Обзор

This study will evaluate the effects of combining motor learning-based therapy with use of the MyoPro , a wearable exoskeletal myoelectrically controlled orthotic device. MyoPro uses electromyographic (EMG) signals from the weak muscles to assist movement of the user's affected arm. The primary objective of this randomized controlled trial is to study the efficacy of using MyoPro in motor learning-based therapy for individuals with chronic stroke (\>6 months post) with severe upper limb motor deficits (Fugl-Meyer for Upper Limb score less than 30) compared with a similar dose of motor learning-based therapy alone. The secondary objectives are to evaluate neuroplasticity mechanisms, identify biomarkers of greater response to the intervention, and explore cost-effectiveness.

Подробное описание

Current rehabilitation methods fail to restore normal arm function for many stroke survivors, particularly those with severe deficits. The main objective of this study is to test efficacy and evaluate underlying neurophysiological mechanisms of a novel approach to treat persistent severe arm deficits after stroke with a combination of MyoPro and motor learning-based therapy. The investigators will also estimate cost effectiveness of this therapeutic approach. Rationale: Motor learning-based therapy is one of the most effective stroke rehabilitation methods available, however its application is challenging for individuals with severe arm impairment because of their limited ability to practice volitional arm movement effectively. The MyoPro is an exoskeletal myoelectrically controlled orthotic device that is custom fitted to an individual's paretic arm and assists the user to move the paretic arm. MyoPro can help with motor learning-based therapy for individuals with severe motor deficits as it motivates practice because even weak muscle activity is translated into patient-initiated arm movement. Preliminary results of motor-learning therapy using MyoPro in the investigators' laboratory showed an increase in Fugl-Meyer for Upper extremity score (FM) of 7.4 points following 18 weeks of training (18 in-clinic therapy sessions over 9 weeks followed by 9 weeks of home practice) for chronic stroke survivors with baseline FM 30. However, comparison of the same dose of combination therapy with motor-learning alone remains to be determined. Study Design: Using a randomized, controlled design, individuals with chronic severe stroke ( 6 months post; Fugl Meyer UE score 30;n=60) will participate in either MyoPro+motor learning (M+ML) or motor learning alone (ML-alone). The study intervention will include 9 weeks of in-clinic training (18 sessions;1.5 hours each) followed by 9 weeks of home practice and a 6-week follow-up. Aim 1 is to determine whether M+ML results in greater treatment gains compared to ML-alone. The primary outcome will be change in FM. Secondary outcome measures will assess overall paretic arm performance and will include: kinematics, muscle tone (Modified Ashworth Scale; MAS), grip/pinch/arm dynamometry, sensory function (Semmes Weinstein mono-filament test, joint proprioception), arm function (Arm Motor Ability Test (AMAT);actigraphy) and quality of life (Stroke Impact Scale (SIS)). Aim 2 is to characterize structural and functional brain changes after treatment. Outcomes include corticospinal excitability (motor evoked potential recruitment curve (MEP-rc)), and functional connectivity (resting state function Magnetic Resonance Imaging(rs-fMRI). Aim 3 is to identify baseline factors associated with greater functional improvement with treatment. Outcomes are as follows: baseline integrity of the stroke-affected corticospinal tract (lesion load, MEP-rc; Diffusion Tensor Imaging); baseline motor ability of the affected arm (FM); baseline functional connectivity (rs-fMRI); device usage and actigraphy. Aim 4 is to evaluate cost effectiveness of M+ML versus ML-alone. Outcomes include: direct/indirect costs and health related quality of life surveys (Short Form 12v.2 and SIS). Significance: This study will address an important problem for the VA patient population by testing for the first time whether MyoPro combined with motor learning-based therapy is superior to motor learning alone in the treatment of chronic, severe arm impairment in stroke. If found to be effective, the study intervention is readily deployable to the clinical setting.

Вмешательства

• Поведенческое motor learning based therapy
  Motor learning based therapy will include functional task/task component training and will be employed to practice hand-to-mouth, forward reach, grasp-release, and object manipulation. Training will include high repetition both in the clinic and during home exercise practice. Tasks will be decomposed into component parts and practiced in this manner with the goal of returning to full task performance as skill develops Training will be tailored to each individual subject's capability and progress
• Поведенческое MyoPro
  The MyoPro supports motor learning-based training by reinforcing coordinated movement practice, allowing for finely incrementalized training progression, and encouraging high repetition of movement. Importantly, the device assists the user to move the paretic limb in a manner they may otherwise be unable to do. This further motivates the user to continue attempts to move the paretic limb. When a user attempts to volitionally contract a weak muscle, sensors embedded within the MyoPro detect the E
• Поведенческое Home Exercise Program
  Every subject will be assigned an individualized HEP. Therapy staff will create written handouts for the user to follow. The HEP will include photographs of the study participant performing his/her exercises/functional tasks along with written instructions. Each individual will have their own personalized HEP that will be created during their study participation and will be dispensed only to them. The HEP will reinforce in-clinic therapy. The HEP will be progressed regularly, and individuals wil

Первичные конечные точки

• Fugl Meyer for Upper Limb (FM) change [Срок оценки: weeks 1, 4, 9, 18 and 24]

Вторичные конечные точки (9)

• Modified Ashworth Scale (MAS) [Срок оценки: weeks 1, 4, 9, 18, 24]
• Upper limb kinematics [Срок оценки: weeks 1, 4, 9, 18, 24]
• Dynamometry [Срок оценки: weeks 1, 4, 9, 18, 24]
• Arm Motor Ability Test [Срок оценки: weeks 1, 4, 9, 18, 24]
• Stroke Impact Scale [Срок оценки: weeks 1, 4, 9, 18, 24]
• Transcranial Magnetic Stimulation (TMS) [Срок оценки: weeks 1, 4, 9, 18, 24]
• Brain network connectivity using resting state functional Magnetic Resonance Imaging (rs-fMRI) [Срок оценки: week 1 and 18]
• Short Form 12v12 [Срок оценки: weeks 1, 9, 18, 24]
• Fractional anisotropy of movement-related tracts [Срок оценки: week 1 and 18]

Критерии участия

Критерии включения

• 18-89 years of age
• Unilateral arm weakness due to stroke (6 months or more since onset)
• Adequate range of motion at the elbow, forearm, wrist, and hand to don the device
• Active shoulder flexion of at least 30 degrees and active shoulder abduction of at least 20 degrees
• Ability to generate volitional, consistent, and detectable EMG signals from the upper arm and forearm sensor sites with wrist in neutral or flexed positions as detected by the MyoPro software
• MAS score less or equal to 3 for the biceps, triceps, supinators and pronators of the impaired arm
• Able to read and comprehend the English language
• Able to follow directions
• Able to provide informed consent
• Medically and psychologically stable.
• Ability to don/doff MyoPro independently or have support as needed.
• Ability to undergo MRI
• Ability to undergo TMS procedures

Критерии исключения

• Previous stroke(s) affecting motor function on the opposite side.
• Persistent and severe shoulder subluxation, pain or dislocation
• Shoulder passive range of motion < 45 degrees in flexion and abduction
• Fixed upper limb contractures on the impaired arm and hand
• Unable to safely support the weight of their arm plus 4 lbs (1.82 kg; the weight of the device) without pain even with arm supported.
• Skin rash or open non-healing wound on impaired arm
• Involuntary movements of the impaired arm
• Pacemaker or other implanted devices that are not compatible with testing procedures or would interfere with donning/doffing and functioning of device.
• Metal in the skull or deformity of the skull
• Claustrophobia, or inability to operate the MRI patient call button
• Contraindications for MRI (standardized screening form for MRI).
• Past history of seizures
• Family history of medication refractory epilepsy
• Pregnancy or pregnancy planning during the study period
• Currently taking medications or substances that lower the threshold for onset of seizure.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Louis Stokes VA Medical Center, Cleveland, OH — Cleveland

Идентификаторы

NCT: NCT05296408 · N3674-R

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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