Vibratory Perturbation-based Pinch Task Training for Stroke Patients

NCT03798340 | Completed

• 1 other identifier: A-ER-104-206
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke Rehabilitation

Keywords

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

Outcome Measures

Primary Outcomes (5)

• 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)

Study Arms (2)

Vibratory perturbed task-specific movement training

EXPERIMENTAL

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; Other: Sensorimotor training

Traditional task-oriented facilitation

ACTIVE COMPARATOR

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

Other: Traditional task-oriented facilitation; Other: Sensorimotor training

Interventions

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.

Vibratory perturbed task-specific movement training

Traditional task-oriented facilitation OTHER

Reach-to-grasp training and hand release training

Traditional task-oriented facilitation

Sensorimotor training OTHER

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

Traditional task-oriented facilitation; Vibratory perturbed task-specific movement training

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Subject has a uncontrolled hypertension
• Subject has major cognitive-perceptual deficits
• Subject has other brain disease

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng-Kung University Hospital

Tainan, 704, Taiwan

Location

Related Publications (1)

• Hsu HY, Kuan TS, Tsai CL, Wu PT, Kuo YL, Su FC, Kuo LC. Effect of a Novel Perturbation-Based Pinch Task Training on Sensorimotor Performance of Upper Extremity for Patients With Chronic Stroke: A Pilot Randomized Controlled Trial. Arch Phys Med Rehabil. 2021 May;102(5):811-818. doi: 10.1016/j.apmr.2020.11.004. Epub 2020 Dec 2.

  PMID: 33278364 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2019
• First Posted: January 9, 2019
• Study Start: March 24, 2016
• Primary Completion: October 4, 2016
• Study Completion: December 31, 2016
• Last Updated: January 30, 2019

Record last verified: 2019-01

Locations

TW (1)