Vibratory Perturbation-based Pinch Task Training for Stroke Patients

Not Applicable

Completed

• Conditions: Stroke Rehabilitation
• Interventions: Other: Traditional task-oriented facilitation; Other: Vibratory perturbed task-specific movement training; Other: Sensorimotor training

• Registration Number: NCT03798340
• Lead Sponsor: National Cheng-Kung University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-24
• Primary Completion: 2016-10-04
• Study Completion: 2016-12-31
• Status Verified: 2019-01
• Study First Submitted: 2019-01-07
• Study First Submitted QC: 2019-01-08
• Study First Posted: 2019-01-09
• Last Update Submitted: 2019-01-28
• Last Update Posted: 2019-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Clinical diagnosis of unilateral cerebral infarction or hemorrhage
2. Be able to perform a pinch task with the thumb and index finger
3. With premorbid right-handedness

Exclusion Criteria

1. Subject has a uncontrolled hypertension
2. Subject has major cognitive-perceptual deficits
3. Subject has other brain disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vibratory perturbed task-specific movement training	Sensorimotor training	Intervention: 10 minutes of traditional sensorimotor facilitation followed by 20 minutes of vibratory perturbed task-specific movement training
Traditional task-oriented facilitation	Traditional task-oriented facilitation	Intervention:10 minutes of traditional sensorimotor training followed by 20 minutes of reach-to-grasp and hand release training.
Traditional task-oriented facilitation	Sensorimotor training	Intervention:10 minutes of traditional sensorimotor training followed by 20 minutes of reach-to-grasp and hand release training.
Vibratory perturbed task-specific movement training	Vibratory perturbed task-specific movement training	Intervention: 10 minutes of traditional sensorimotor facilitation followed by 20 minutes of vibratory perturbed task-specific movement training

Primary Outcome Measures

Name	Time	Method
Change in the result of Fugl-Meyer assessment for UE motor function	baseline, endpoint (6 weeks) and follow up (18 weeks)	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.
Change in the result of Semmes-Weinstein monofilament (SWM) test	baseline, endpoint (6 weeks) and follow up (18 weeks)	The Semmes-Weinstein monofilamenttest examines the cutaneous pressure threshold, range from 1.65-6.65. Higher values represent a worse outcome.
Change in the result of Modified Ashworth scale (MAS)	baseline, endpoint (6 weeks) and follow up (18 weeks)	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.
Change in the result of Box and blocks test	baseline, endpoint (6 weeks) and follow up (18 weeks)	The score is the number of blocks carried from one box to the other in one minute. Higher values represent a better outcome.
Change in the result of Motor Activity Log	baseline, endpoint (6 weeks) and follow up (18 weeks)	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.

Trial Locations

Locations (1)

National Cheng-Kung University Hospital; 🇨🇳 Tainan, Taiwan