Short-Term Effects of Whole-Body Vibration on Upper Extremity Function in Subjects With Poststroke Hemiplegia

NCT03963258 | Unknown

• 1 other identifier: IRB00006761-M2018112
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the effect of whole body vibration on upper limb motor function in hemiplegic patients with subacute stroke

Conditions

Rehabilitation; Stroke; Hemiplegia; Physical Therapy Modalities; Electromyography; Upper Extremity; Recovery of Function; Vibration

Keywords

Whole-Body vibration; Stroke; Hemiplegia; upper extremity; Rehabilitation training; Muscular surface EMG; Vibration training

Outcome Measures

Primary Outcomes (3)

• upper-extremity Fugl-Meyer Scale

  the assessment is scored by summing item ratings and reporting the aggregate score out of 66 points,with higher scores representing a greater UE motor ability summing item ratings and reporting the aggregate score out of 66 points, with higher scores representing a greater UE motor ability

  After the 3-week intervention period

• Wolf Motor Function Test

  participants were timed as they completed 15 activities that progressively involved more difficult arm movements and interactions with objects such as lifting a soda can, stacking checkers, and folding a towel. We reported the average time to perform the 15 items and the evaluator rated the normalcy of these items with a 6-point ordinal scale (range,0-5) using the functional ability scale.

  After the 3-week intervention period

• Surface electromyography

  Surface electromyography was used to measure the integrated EMG（IEMG）of the biceps and triceps during maximum isometric voluntary contraction（MIVC）of the affected elbow flexion and extension and then the co-contraction rate（CR）was calculated

  After the 3-week intervention period

Study Arms (2)

control group

ACTIVE COMPARATOR

Over a 3-week period, the subjects in the control group received 1 hour daily of conventional upper limb training 5 times a week,including compensatory techniques for activities of daily living, UE strength, therapist-guided techniques for facilitating normal UE movement patterns,and range of motion and traditional positioning

Other: conventional upper limb training

whole-body vibration group

EXPERIMENTAL

Subjects in the whole-body vibration group received half an hour of daily conventional upper limb training, followed by whole-body vibration training for an additional half hour per day,5 days per week during a 3-week period

Device: whole-body vibration training

Interventions

whole-body vibration training DEVICE

The subjects were exposed to alternating vertical sinusoidal vibration using a Galileo tilting table system.The frequency of WBV ranged from 5 to 20 Hz, and the amplitude ranged from 1 to 6 mm.The subjects were kneeled on the ground, both shoulders flexed at 90 degrees, elbows slightly flexed, their trunk bent in this position and contacted on the platform board with their palms equidistant from the midpoint of the board

Also known as: vibration training

whole-body vibration group

conventional upper limb training OTHER

compensatory techniques for activities of daily living, UE strength, therapist-guided techniques for facilitating normal UE movement patterns,and range of motion and traditional positioning

control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• After unilateral stroke 1 to 6 months
• An ischemic or hemorrhagic poststroke hemiplegia
• No cognitive impairment
• Able to reach Brunnstrom stage II or above in the proximal and distal parts of the arms
• No excessive pain in the more affected upper extremity
• All subjects agreed to participate in the study after receiving explanations regarding the purpose and procedures of the experiment, and they signed an informed consent statement before participation

You may not qualify if:

• Unsteadiness
• Accompanied by important organs (such as heart, liver, lung, kidney) dysfunction or malignant tumors
• Contraindications to general vibration training exist
• Combined with other diseases causing upper limb dysfunction

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking Univercity Third Hospital

Beijing, No State Or Province, 100191, China

RECRUITING

MeSH Terms

Conditions

Stroke; Hemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• mouwang zhou, master

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

mouwang zhou, master

CONTACT

13910092892; zhoumouwang@163.com

hongbo Li, bachelor

CONTACT

17778025997; 1184455890@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Rehabilitation Medicine , Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: December 4, 2018
• First Posted: May 24, 2019
• Study Start: June 15, 2019
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: July 2, 2019

Record last verified: 2019-07

Locations

CN (1)