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

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

Study Overview

• Status: Unknown
• Conditions: Stroke; Rehabilitation; Hemiplegia; Recovery of Function; Physical Therapy Modalities; Electromyography; Upper Extremity; Vibration
• Intervention / Treatment: Other: conventional upper limb training; Device: whole-body vibration training

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • No State Or Province
    • Beijing, No State Or Province, China, 100191
      • Recruiting
      • Peking Univercity Third Hospital
      • Sub-Investigator: Hongbo Li, bachelor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: vibration training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Principal Investigator: mouwang zhou, master, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 15, 2019
• Primary Completion (ANTICIPATED): May 1, 2020
• Study Completion (ANTICIPATED): May 1, 2020

Study Registration Dates

• First Submitted: December 4, 2018
• First Submitted That Met QC Criteria: May 23, 2019
• First Posted (ACTUAL): May 24, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 2, 2019
• Last Update Submitted That Met QC Criteria: July 1, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Stroke; Vibration training; upper extremity; Hemiplegia; Whole-Body vibration; Rehabilitation training; Muscular surface EMG
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Paralysis; Hemiplegia
• Other Study ID Numbers: IRB00006761-M2018112

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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