Vibratory Perturbation-based Pinch Task Training for Stroke Patients

Study Overview
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Brief Summary
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The investigator assumed that perturbed-event-induced vibrotactile cueing enable more precision arm movement adjustment, sensory function and dexterity improvement in the spastic arm. Thus the specific aim of the study was to develop a vibrotactile therapy system that can provide vibrotactile feedback through the pinch performance of the hand when countering mechanically induced perturbations and also analyzed training effects of the perturbation-based pinch task training system on the sensorimotor performance of the hands for stroke patients.

Official Title
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Effects of Motor Task-Specific Therapy Synchronized With Vibrotactile Cueing on Sensorimotor Performance of Upper Extremity for the Chronic Stroke Patients

Conditions
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Stroke Rehabilitation

Intervention / Treatment
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* Other: Vibratory perturbed task-specific movement training
* Other: Traditional task-oriented facilitation
* Other: Sensorimotor training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of unilateral cerebral infarction or hemorrhage Be able to perform a pinch task with the thumb and index finger With premorbid right-handedness Exclusion Criteria: Subject has a uncontrolled hypertension Subject has major cognitive-perceptual deficits Subject has other brain disease

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vibratory perturbed task-specific movement training<br>Intervention: 10 minutes of traditional sensorimotor facilitation followed by 20 minutes of vibratory perturbed task-specific movement training | Other: Vibratory perturbed task-specific movement training<br>* The perturbation-based pinch task training was conducted with the affected hand placed on the pinch device. The horizontal vibratory perturbation was generated for a total of 20 minutes by two recoil-type actuators with a frequency of 30 Hz and an amplitude of 2 mm, and intermittent exposure (10 s per 30 s). Each training session was divided into eight cycles with a training interval of 2 min per 2.5 min.<br>Other: Sensorimotor training<br>* Targeted to goals that are relevant to the sensorimotor facilitation of the patient<br>|
| Active Comparator: Traditional task-oriented facilitation<br>Intervention:10 minutes of traditional sensorimotor training followed by 20 minutes of reach-to-grasp and hand release training. | Other: Traditional task-oriented facilitation<br>* Reach-to-grasp training and hand release training<br>Other: Sensorimotor training<br>* Targeted to goals that are relevant to the sensorimotor facilitation of the patient<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the result of Fugl-Meyer assessment for UE motor function | Each item is rated on a three-point ordinal scale (2 points for the detail being performed completely, 1 point for the detail being performed partially, and 0 for the detail not being performed). The maximum motor performance score is 66 points for the upper extremity.completely, 1 point for the detail being performed partially, and 0 for the detail not being performed). The maximum motor performance score is 66 points for the upper extremity. | baseline, endpoint (6 weeks) and follow up (18 weeks) | 
| Change in the result of Modified Ashworth scale (MAS) | Muscle tone is defined by the resistance of a muscle being stretched.The tester graded the resistance felt, with a single score. The higher values represent a worse outcome. 0 point for no increase in muscle tone; 1 point for slight increase in muscle tone, manifested by a catch or by minimal resistance at the end of the range of motion (ROM) when the affected part is moved in flexion or extension; 1 + for slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM; 2 point for more marked increase in muscle tone through most of the ROM, but affected parteasily moved, 3 point for considerable increase in muscle tone and passive movement difficult; 4 point for affected part rigid in flexion or extension. | baseline, endpoint (6 weeks) and follow up (18 weeks) | 
| Change in the result of Box and blocks test | The score is the number of blocks carried from one box to the other in one minute. Higher values represent a better outcome. | baseline, endpoint (6 weeks) and follow up (18 weeks) | 
| Change in the result of Semmes-Weinstein monofilament (SWM) test | The Semmes-Weinstein monofilamenttest examines the cutaneous pressure threshold, range from 1.65-6.65. Higher values represent a worse outcome. | baseline, endpoint (6 weeks) and follow up (18 weeks) | 
| Change in the result of Motor Activity Log | MAL is a structured interview with testing sensitivity used to examine how much (amount of use, AOU) and how well (quality of movement, QOM) the subject uses their more-affected arm. For the 30 items MAL, each item is scored on a 0-5-ordinal scale. | baseline, endpoint (6 weeks) and follow up (18 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, perturbation-based training, task-specific motor training, recovery of function