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Completed

NCT Number: NCT03798340

Vibratory Perturbation-based Pinch Task Training for 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.

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Key information

Conditions

Stroke Rehabilitation Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cheng-Kung University Hospital

Tainan, 704, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vibratory perturbed task-specific movement training

Other

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.

Traditional task-oriented facilitation

Other

Reach-to-grasp training and hand release training

Sensorimotor Training

Other

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 9, 2019
Registry last updated
Jan 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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