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Vibratory Perturbation-based Pinch Task Training for Stroke Patients

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03798340
Enrollment
20
Registered
2019-01-09
Start date
2016-03-24
Completion date
2016-12-31
Last updated
2019-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke Rehabilitation

Keywords

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

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.

Interventions

OTHERVibratory 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.

OTHERTraditional task-oriented facilitation

Reach-to-grasp training and hand release training

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

Sponsors

National Cheng-Kung University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in the result of Fugl-Meyer assessment for UE motor functionbaseline, 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.
Change in the result of Modified Ashworth scale (MAS)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.
Change in the result of Box and blocks testbaseline, 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.
Change in the result of Semmes-Weinstein monofilament (SWM) testbaseline, 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.
Change in the result of Motor Activity Logbaseline, 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.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026