Vibration Approach Functions in Upper Extremities for People After Stroke

NCT05969249 | Unknown

• 1 other identifier: N202211038
• Study Type: interventional
• Target: 124
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will develop a vibration rehabilitation system for the upper extremities and provide strong evidence-based information regarding the mechanism and rehabilitation of stroke patients through the application of vibration by comparing the benefits of its clinical outcome with those of traditional rehabilitation methods. Based on these findings, we could create precision vibration exercise programs to improve the health of stroke patients.

Conditions

Stroke

Outcome Measures

Primary Outcomes (5)

• Upper Extremity motor control of Fugl-Meyer Assessment (FMA-UE)

  Assessment the upper limb movement, sensation and coordination ability of stroke patients,

  Change from Baseline at eight weeks

• Motor Assessment Score

  Assessment level of impairment and upper arm function, hand movements and advanced hand activities in patients with stroke. Patients perform each task 3 times, only the best performance is recorded. Items are assessed using a 7-point scale (0 to 6) and score of 6 indicates optimal motor behavior.

  Change from Baseline at eight weeks

• Minnesota Manual Dexterity Test

  This test intends to assess bimanual dexterity and coordination. The MMDT consists of a thin board with 60 holes. The blocks have a diameter of 3.7 cms and are red and black. The blocks and holes are approximately the same size. It has 2 subsets the placing test and the turning test. A log is maintained of the time taken for these steps.

  Change from Baseline at eight weeks

• active and passive joint perception tests and coordination control tasks in bilateral hand grip strength

  The task operation process includes the three parts of grip force formation, sustained grip and grip force release, which are performed alternately between the two hands at the same time.The grip strength between the left and right hands is continued alternately for 3 rounds. The data analysis is to take the best performance among the 3 rounds for analysis.

  Change from Baseline at eight weeks

• the Wolf Motor Function Test

  Through timed and practical exercises, the Wolf Motor Function Test measures upper extremity motor abilities.

  Change from Baseline at eight weeks

Study Arms (2)

Experimental

EXPERIMENTAL

Each patient will go on a treatment with 24 sections, and each section is 60 minutes. The experimental group received 30 minutes of effective vibration intervention with a vibration frequency of 30 Hz and an amplitude of 5 mm on the affected upper limb. The vibration duration was 1 minute, and there was also a 1-minute rest interval. After completion, 30 minutes of traditional clinical rehabilitation training was also performed.

Device: Upper limb in vibration training

Active Comparator:

ACTIVE COMPARATOR

Each patient will go on a treatment with 24 sections, and each section is 60 minutes. During the intervention, it is necessary to wear an upper limb vibration device on the affected limb, and perform a sham vibration intervention (sham vibration) with a vibration frequency of 1 Hz (excluding the effective vibration frequency range of 4-50 Hz proposed in previous studies) and an amplitude of 5 mm for 30 minutes. The duration of the vibration is 1 minute, and there is a rest interval of 1 minute. After completion, 30 minutes of traditional clinical rehabilitation training will be performed.

Device: Upper limb in vibration training

Interventions

Upper limb in vibration training DEVICE

The stroke subjects were all involved in the training,wear upper and lower extremity vibrators,the posture for intervention is hemiplegic upper limbs with shoulder joints slightly bent and abducted at 45 degrees, with elbows bent at 90 degrees and wrists centered. The elbow angle of this posture is set by the elbow joint rotation axis of the upper limb vibrator. The set angle is the movable angle range of 80-110 degrees of elbow bending. The vibration rehabilitation password accepted by all subjects is "Try to keep the elbow joint bent at 90 degrees during the vibration process, Resist the force of the vibration and try not to move".

Active Comparator:; Experimental

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The doctor diagnosed cerebrovascular disease caused by cerebrovascular embolism or hemorrhage
• The patient suffers from stroke and has no other serious complications that significantly affect upper limb function
• The stroke is stable
• The degree of recovery from stroke has reached the third stage of the Brownstrong action stage or more
• The subject's cognitive function is normal;
• The muscle tension of the hemiplegic limb must be less than 3 on the modified Ashewurth scale
• Vibration or rehabilitation intervention can be performed for 1 hour under the balance of sitting posture
• Understand the experiment and agree

You may not qualify if:

• This stroke is a recurrence
• The muscle tension of the hemiplegic limbs is too high and they are completely unable to exercise alone
• The patient has unilateral hemianopia or significant unilateral neglect in vision, which seriously affects the execution of physical movements
• Patients with vestibular, cerebellum and other diseases that seriously affect the execution of movements
• Patients with orthopedic or trauma and other factors that cause discomfort such as pain during evaluation or intervention
• Patients who are unable to communicate effectively due to cognitive abnormalities caused by stroke
• The patient has other related factors such as neurological and psychiatric diseases, which are affected by physical activity during the experiment

Sponsors & Collaborators

• Taipei Medical University Shuang Ho Hospital: lead

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Chueh-Ho Lin, Ph.D.

  250 Wu-Hsing Street, Taipei City, Taiwan 110, R.O.C.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chueh-Ho Lin, Ph.D.

CONTACT

+88627361661; chueh.ho@tmu.edu.tw

Jia-Lan CHANG, Master

CONTACT

+88622490088; 08173@s.tmu.edu.tw

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: July 24, 2023
• First Posted: August 1, 2023
• Study Start: August 7, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 31, 2024
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share