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

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ClinicalTrials.gov Identifier: NCT03963258
Recruitment Status : Recruiting
First Posted : May 24, 2019
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
Mouwang Zhou, Peking University Third Hospital

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

Condition or disease Intervention/treatment Phase
Rehabilitation Stroke Hemiplegia Physical Therapy Modalities Electromyography Upper Extremity Recovery of Function Vibration Device: whole-body vibration training Other: conventional upper limb training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Short-Term Effects of Whole-Body Vibration on Upper Extremity Function in Subjects With Poststroke Hemiplegia
Actual Study Start Date : June 15, 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: control group
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
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

Experimental: whole-body vibration group
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
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
Other Name: vibration training




Primary Outcome Measures :
  1. upper-extremity Fugl-Meyer Scale [ Time Frame: After the 3-week intervention period ]
    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

  2. Wolf Motor Function Test [ Time Frame: After the 3-week intervention period ]
    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.

  3. Surface electromyography [ Time Frame: After the 3-week intervention period ]
    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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03963258


Contacts
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Contact: mouwang zhou, master 13910092892 zhoumouwang@163.com
Contact: hongbo Li, bachelor 17778025997 1184455890@qq.com

Locations
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China, No State Or Province
Peking Univercity Third Hospital Recruiting
Beijing, No State Or Province, China, 100191
Sub-Investigator: Hongbo Li, bachelor         
Sponsors and Collaborators
Peking University Third Hospital
Investigators
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Principal Investigator: mouwang zhou, master Peking University Third Hospital

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Responsible Party: Mouwang Zhou, Director, Head of Rehabilitation Medicine , Principal Investigator, Clinical Professor, Peking University Third Hospital
ClinicalTrials.gov Identifier: NCT03963258     History of Changes
Other Study ID Numbers: IRB00006761-M2018112
First Posted: May 24, 2019    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Mouwang Zhou, Peking University Third Hospital:
Whole-Body vibration
Stroke
Hemiplegia
upper extremity
Rehabilitation training
Muscular surface EMG
Vibration training
Additional relevant MeSH terms:
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Hemiplegia
Nervous System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms