Vibratory Perturbation-based Pinch Task Training for Stroke Patients

Stroke Rehabilitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03798340
• Other study ID #: A-ER-104-206
• Status: Completed
• Phase: N/A
• Start date: March 24, 2016
• Est. completion date: December 31, 2016

Study information

• Verified date: January 2019
• Source: National Cheng-Kung University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 31, 2016
• Est. primary completion date: October 4, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke
• Stroke Rehabilitation

Intervention

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.
• Traditional task-oriented facilitation
Reach-to-grasp training and hand release training
• Sensorimotor training
Targeted to goals that are relevant to the sensorimotor facilitation of the patient

Locations

Country	Name	City	State
Taiwan	National Cheng-Kung University Hospital	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)