Vibratory Perturbation-based Pinch Task Training for Stroke Patients

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

Vibratory perturbed task-specific movement training

Traditional task-oriented facilitation

Sensorimotor training

About this trial

This is an interventional treatment trial for Stroke Rehabilitation focused on measuring stroke, perturbation-based training, task-specific motor training, recovery of function

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

National Cheng-Kung University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vibratory perturbed task-specific movement training

Traditional task-oriented facilitation

Arm Description

Intervention: 10 minutes of traditional sensorimotor facilitation followed by 20 minutes of vibratory perturbed task-specific movement training

Intervention:10 minutes of traditional sensorimotor training followed by 20 minutes of reach-to-grasp and hand release training.

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03798340

First Posted

January 7, 2019

Last Updated

January 28, 2019

Sponsor

National Cheng-Kung University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03798340

Brief Title

Vibratory Perturbation-based Pinch Task Training for Stroke Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

March 24, 2016 (Actual)

Primary Completion Date

October 4, 2016 (Actual)

Study Completion Date

December 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Cheng-Kung University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke Rehabilitation

Keywords

stroke, perturbation-based training, task-specific motor training, recovery of function

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vibratory perturbed task-specific movement training

Arm Type

Experimental

Arm Description

Intervention: 10 minutes of traditional sensorimotor facilitation followed by 20 minutes of vibratory perturbed task-specific movement training

Arm Title

Traditional task-oriented facilitation

Arm Type

Active Comparator

Arm Description

Intervention:10 minutes of traditional sensorimotor training followed by 20 minutes of reach-to-grasp and hand release training.

Intervention Type

Other

Intervention Name(s)

Vibratory perturbed task-specific movement training

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Traditional task-oriented facilitation

Intervention Description

Reach-to-grasp training and hand release training

Intervention Type

Other

Intervention Name(s)

Sensorimotor training

Intervention Description

Targeted to goals that are relevant to the sensorimotor facilitation of the patient

Primary Outcome Measure Information:

Title

Change in the result of Fugl-Meyer assessment for UE motor function

Description

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.

Time Frame