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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03963258
Other study ID # IRB00006761-M2018112
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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