Vibratory Perturbation-based Pinch Task Training for Stroke Patients

January 28, 2019 updated by: National Cheng-Kung University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Tainan, Taiwan, 704
        • National Cheng-Kung University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vibratory perturbed task-specific movement training
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
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.
Other: Sensorimotor training
Targeted to goals that are relevant to the sensorimotor facilitation of the patient
Active Comparator: Traditional task-oriented facilitation
Intervention:10 minutes of traditional sensorimotor training followed by 20 minutes of reach-to-grasp and hand release training.
Other: Sensorimotor training
Targeted to goals that are relevant to the sensorimotor facilitation of the patient
Other: Traditional task-oriented facilitation
Reach-to-grasp training and hand release training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the result of Fugl-Meyer assessment for UE motor function
Time Frame: 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.
baseline, endpoint (6 weeks) and follow up (18 weeks)
Change in the result of Modified Ashworth scale (MAS)
Time Frame: 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.
baseline, endpoint (6 weeks) and follow up (18 weeks)
Change in the result of Box and blocks test
Time Frame: 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.
baseline, endpoint (6 weeks) and follow up (18 weeks)
Change in the result of Semmes-Weinstein monofilament (SWM) test
Time Frame: 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.
baseline, endpoint (6 weeks) and follow up (18 weeks)
Change in the result of Motor Activity Log
Time Frame: 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.
baseline, endpoint (6 weeks) and follow up (18 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cheng-Kung University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2016

Primary Completion (Actual)

October 4, 2016

Study Completion (Actual)

December 31, 2016

Study Registration Dates

First Submitted

January 7, 2019

First Submitted That Met QC Criteria

January 8, 2019

First Posted (Actual)

January 9, 2019

Study Record Updates

Last Update Posted (Actual)

January 30, 2019

Last Update Submitted That Met QC Criteria

January 28, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-ER-104-206

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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