Whole Body Vibration in Chronic Stroke

Stroke Clinical Trial

Official title:

Application of Vertical Whole Body Vibration in Stroke Patients: Neuromuscular Effects, and Clinical Efficacy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01822704
• Other study ID #: HSEARS20130209001
• Status: Recruiting
• Phase: N/A
• First received: March 28, 2013
• Last updated: April 1, 2013
• Start date: March 2013
• Est. completion date: May 2015

Study information

• Verified date: April 2013
• Source: The Hong Kong Polytechnic University
• Contact: Marco YC Pang, PhD
• Phone: 852-2766-7156
• Email: Marco.Pang[@]polyu.edu.hk
• Is FDA regulated: No
• Health authority: Hong Kong: The Hong Kong Polytechnic University
• Study type: Interventional

Clinical Trial Summary

This study is a randomized controlled trial aimed to assess the efficacy of a 10-week whole body vibration training program on physical functioning, societal participation and quality of life in individuals with chronic stroke. It is hypothesized that the whole body vibration program will induce significantly more gain in physical functioning, societal participation, and quality of life in chronic stroke patients, compared with the control group.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 81
• Est. completion date: May 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• diagnosis of a hemispheric stroke

• chronic stroke (onset of 6 months or more)

• aged 18 years or older

• medically stable

• able to stand for at least 1 minute with hand support

• Abbreviated Mental Test score at 6 or more

• Chedoke McMaster Stroke Assessment leg or foot score less than 7 points

Exclusion Criteria:

• recurrent stroke

• brainstem or cerebellar stroke

• other neurological conditions

• significant musculoskeletal conditions (e.g. amputations)

• vestibular disorders

• peripheral vascular disease

• other serious illnesses

• other contraindications to exercise.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Low intensity whole body vibration

• High intensity whole body vibration

Behavioral:
• Leg exercises

Locations

Country	Name	City	State
Hong Kong	The Hong Kong Polytechnic University	Hung Hom	Kowloon

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

References & Publications (1)

Lau RW, Yip SP, Pang MY. Whole-body vibration has no effect on neuromotor function and falls in chronic stroke. Med Sci Sports Exerc. 2012 Aug;44(8):1409-18. doi: 10.1249/MSS.0b013e31824e4f8c. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Isometric knee muscle strength		Week 0	No
Primary	Isometric knee muscle strength		week 10	No
Secondary	Eccentric knee muscle strength at a velocity of 60 degrees per second		Week 0	No
Secondary	Eccentric knee muscle strength at a velocity of 60 degrees per second		week 10	No
Secondary	Concentric knee muscle strength at a velocity of 60 degrees per second		week 0	No
Secondary	Concentric knee muscle strength at a velocity of 60 degrees per second		week 10	No
Secondary	Distance walked in the Six Minute Walk Test		week 0	No
Secondary	Distance walked in the Six Minute Walk Test		week 10	No
Secondary	Average oxygen consumption rate during the Six Minute Walk Test		week 0	No
Secondary	Average oxygen consumption rate during the Six Minute Walk Test		week 10	No
Secondary	Time taken to complete the Timed Up and Go Test		week 0	No
Secondary	Time taken to complete the Timed Up and Go Test		week 10	No
Secondary	Time taken to complete the Five-times-sit-to-stand test		week 0	No
Secondary	Time taken to complete the Five-times-sit-to-stand test		week 10	No
Secondary	Distance reached in the Functional Reach test		Week 0	No
Secondary	Distance reached in the Functional Reach test		week 10	No
Secondary	Balance score as measured by the Mini-Balance Evaluation Systems Test		week 0	No
Secondary	Balance score as measured by the Mini-Balance Evaluation Systems Test		week 10	No
Secondary	Walking ability as measured by the Functional Ambulation Category		week 0	No
Secondary	Walking ability as measured by the Functional Ambulation Category		week 10	No
Secondary	Balance confidence scores as measured by the Activities-specific Balance Confidence Scale		week 0	No
Secondary	Balance confidence scores as measured by the Activities-specific Balance Confidence Scale		week 10	No
Secondary	Quality of life score as measured by the 12-item Short Form Health Survey		week 0	No
Secondary	Quality of life score as measured by the 12-item Short Form Health Survey		week 10	No
Secondary	Level of activity participation as measured by the Frenchay Activities Index		week 0	No
Secondary	Level of activity participation as measured by the Frenchay Activities Index		Week 10	No
Secondary	Level of perceived environmental barriers as measured by the Craig Hospital Inventory of Environmental Factors		week 0	No
Secondary	Level of perceived environmental barriers as measured by the Craig Hospital Inventory of Environmental Factors		week 10	No
Secondary	Ankle spasticity score as measured by the Modified Ashworth Scale		week 0	No
Secondary	Ankle spasticity score as measured by the Modified Ashworth Scale		week 10	No