Effects of Intensive Robot-assisted Therapy in Patients With Subacute Stroke "RT"

Completed

Phase N/A Results N/A

Trial Description

Robot-assisted training (RT) devices developed to date have a significant impact on stroke rehabilitation. Several research groups have developed the robotic devices and examined their efficacy on improving upper limb function after stroke. All these robotic devices have been applied in stroke rehabilitation and their efficacy are evaluated, but the scientific evidence for the mechanisms of RT-induced recovery, the optimal treatment intensity, and the impact on physiological responses is still lacking.
This trial is to examine (1) the immediate effects of treatment intensity in RT on sensorimotor impairments and functional performance in patients with subacute stroke; (2) the long-term benefits of treatment intensity in RT by conducting a 6-month follow up evaluation; and (3) the effects of RT on cortical/movement reorganization as well as on the physiological markers of inflammation, oxidative stress, and erythrocyte deformability. These overall findings will help better understanding of the efficacy of RT on functional outcomes, brain and movement reorganization, and physiological markers.

Detailed Description

Subacute stroke participants will be recruited from the Chang Gung Memorial Hospital and then were randomly assigned to 1 of the 3 groups: RT with higher-intensity group, RT with lower-intensity group, and conventional intervention group. Assessments on sensorimotor impairments (Fugl Mayer Assessment, Motor Status Scale, Modified Ashworth Scale, Myoton, Muscle Metabolism, Box and Block Test, and Revised Nottingham Sensory assessment) and functional performance (Functional Independence Measure, Motor Activity Log, ABILHAND Questionnaire, Adelaide Activities Profile, EQ-5D-5L, and accelerometer) take about 40 minutes to complete. Evaluation of brain reorganization using functional magnetic resonance image and movement patterns by kinematic analysis take about 1 hour for each examination. Blood samples of the patients (12 ml.) will be collected to examine the physiological markers (ie, inflammation-related markers, oxidative stress markers, and erythrocyte deformability) before and after intervention. Total 24 ml blood will be collected in this study. Except for the blood taking, all the examinations are non-invasive.

Conditions

Interventions

  • RT Device
    Other Names: Bi-Manu-Track; Reha-Stim Co., Berlin, Germany
    Intervention Desc: The Bi-Manu-Track enables the symmetrical practice of 2 movement patterns in conjunction with computer games: forearm pronation-supination and wrist flexion-extension. Each movement has three computer-controlled modes: (1) passive-passive, with both arms being moved by the machine with speed and range of motion individually adjustable; (2) active-passive, with the nonaffected arm driving the affected arm in a mirror-like fashion; and (3) active-active, with both arms actively moving against resistance. The speed of movement, the amount of resistance, and the range of movement can be adjusted individually. The device has a mechanical breaking of the movement when the torques exceeded 4 Nm, emergency breaks in the reach of the patients, skin friendly materials, and minimal risk for contusions.
    ARM 1: Kind: Experimental
    Label: Higher-intensity RT group
    Description: All participants received a duration-matched intervention for 90-120 minutes/day, 5 days/week for 4 consecutive weeks. For the RT groups, they will receive RT training together with functional rehabilitation trainings. Within 1 training session, each patient in the higher-intensity RT group will use Bi-Manual-Tract topractice 400-600 repetitions of the mode 1 and 800-1000 repetitions of mode 2, totaling 1200-1600 repetitions, respectively for the forearm and the wrist movements. In addition, the patients will practice 100-200 repetitions in mode 3, if application.
    ARM 2: Kind: Experimental
    Label: Lower-intensity RT group
    Description: Patients in the lower-intensity RT received half the number of the repetitions per unit of time than patients in the higher-intensity RT group. Within 1 training session, patients in the lower-intensity RT group will practice 200-300 repetitions of the mode 1 and 400-500 repetitions of mode 2, totaling 600-800 repetitions, respectively for the forearm and the wrist movements. In addition, the patients will practice 50-100 repetitions in mode 3, if application.
  • Conventional rehabilitation (CR) Behavioral
    Other Names: CR
    Intervention Desc: CR will focus on neurodevelopmental techniques with emphasis on functional tasks when possible. The functional training will be designed based on patients' motor capacity and include gross motor and fine motor dexterity training, and transitive and intransitive training. Stretching of the more affected limb, passive and active range of movements, and normalizing muscle tone by applying reflex inhibition patterns, inhibiting abnormal patterns, weight bearing with the affected limb will be applied to assist in functional task practice.
    ARM 1: Kind: Experimental
    Label: Higher-intensity RT group
    Description: All participants received a duration-matched intervention for 90-120 minutes/day, 5 days/week for 4 consecutive weeks. For the RT groups, they will receive RT training together with functional rehabilitation trainings. Within 1 training session, each patient in the higher-intensity RT group will use Bi-Manual-Tract topractice 400-600 repetitions of the mode 1 and 800-1000 repetitions of mode 2, totaling 1200-1600 repetitions, respectively for the forearm and the wrist movements. In addition, the patients will practice 100-200 repetitions in mode 3, if application.
    ARM 2: Kind: Experimental
    Label: Lower-intensity RT group
    Description: Patients in the lower-intensity RT received half the number of the repetitions per unit of time than patients in the higher-intensity RT group. Within 1 training session, patients in the lower-intensity RT group will practice 200-300 repetitions of the mode 1 and 400-500 repetitions of mode 2, totaling 600-800 repetitions, respectively for the forearm and the wrist movements. In addition, the patients will practice 50-100 repetitions in mode 3, if application.
    ARM 3: Kind: Experimental
    Label: Conventional rehabilitation (CR) group
    Description: The CR group will be designed to control for the duration of therapeutic activities. CR will focus on neurodevelopmental techniques with emphasis on functional tasks when possible. The functional training will be designed based on patients' motor capacity and include gross motor and fine motor dexterity training, and transitive and intransitive training. Stretching of the more affected limb, passive and active range of movements, and normalizing muscle tone by applying reflex inhibition patterns, inhibiting abnormal patterns, weight bearing with the affected limb will be applied to assist in functional task practice.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Fugl-Meyer Assessment (FMA) At baseline and immediately after the completion of intervention No
Primary Motor Status Scale (MSS) At baseline and immediately after the completion of intervention No
Primary Modified Ashworth Scale (MAS) At baseline and immediately after the completion of intervention No
Primary MyotonPRO At baseline and immediately after the completion of intervention No
Primary Muscle metabolism (NIRS) At baseline and immediately after the completion of intervention No
Primary Box and Block Test (BBT) At baseline and immediately after the completion of intervention No
Primary Revised Nottingham Sensory Assessment (RNSA) At baseline and immediately after the completion of intervention No
Primary Functional Independence Measure (FIM) At baseline and immediately after the completion of intervention No
Primary Motor Activity Log (MAL) At baseline, immediately after the completion of intervention, at a 6-month follow up No
Primary ABILHAND Questionnaire At baseline, immediately after the completion of intervention, at a 6-month follow up No
Primary Adelaide Activities Profile (AAP) At baseline, immediately after the completion of intervention, at a 6-month follow up No
Primary EQ-5D-5L At baseline and immediately after the completion of intervention No
Primary Accelerometers At baseline, immediately after the completion of intervention, at a 6-month follow-up. No
Primary Functional magnetic resonance imaging (fMRI) At baseline and immediately after the completion of intervention No
Primary Kinematic analysis At baseline and immediately after the completion of intervention No
Primary Inflammatory markers At baseline and immediately after the completion of intervention No
Primary Oxidative stress markers At baseline and immediately after the completion of intervention No
Primary Erythrocyte deformability At baseline and immediately after the completion of intervention No
Primary Blood glucose indicators At baseline and immediately after the completion of intervention No

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