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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03963258
• Other study ID #: IRB00006761-M2018112
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2019
• Est. completion date: May 2020

Study information

• Verified date: July 2019
• Source: Peking University Third Hospital
• Contact: mouwang zhou, master
• Phone: 13910092892
• Email: zhoumouwang[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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:
• 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

Locations

Country	Name	City	State
China	Peking Univercity Third Hospital	Beijing	No State Or Province

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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