Clinical trial NCT01822704: Whole Body Vibration in Chronic Stroke
Official title: Application of Vertical Whole Body Vibration in Stroke Patients: Neuromuscular Effects, and Clinical Efficacy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Stroke
Exercise
Rehabilitation
Vibration
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2013-04-02
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Isometric knee muscle strength
timeFrame: Week 0
measure: Isometric knee muscle strength
timeFrame: week 10
Secondary outcomes:
measure: Eccentric knee muscle strength at a velocity of 60 degrees per second
timeFrame: Week 0
measure: Eccentric knee muscle strength at a velocity of 60 degrees per second
timeFrame: week 10
measure: Concentric knee muscle strength at a velocity of 60 degrees per second
timeFrame: week 0
measure: Concentric knee muscle strength at a velocity of 60 degrees per second
timeFrame: week 10
measure: Distance walked in the Six Minute Walk Test
timeFrame: week 0
measure: Distance walked in the Six Minute Walk Test
timeFrame: week 10
measure: Average oxygen consumption rate during the Six Minute Walk Test
timeFrame: week 0
measure: Average oxygen consumption rate during the Six Minute Walk Test
timeFrame: week 10
measure: Time taken to complete the Timed Up and Go Test
timeFrame: week 0
measure: Time taken to complete the Timed Up and Go Test
timeFrame: week 10
measure: Time taken to complete the Five-times-sit-to-stand test
timeFrame: week 0
measure: Time taken to complete the Five-times-sit-to-stand test
timeFrame: week 10
measure: Distance reached in the Functional Reach test
timeFrame: Week 0
measure: Distance reached in the Functional Reach test
timeFrame: week 10
measure: Balance score as measured by the Mini-Balance Evaluation Systems Test
timeFrame: week 0
measure: Balance score as measured by the Mini-Balance Evaluation Systems Test
timeFrame: week 10
measure: Walking ability as measured by the Functional Ambulation Category
timeFrame: week 0
measure: Walking ability as measured by the Functional Ambulation Category
timeFrame: week 10
measure: Balance confidence scores as measured by the Activities-specific Balance Confidence Scale
timeFrame: week 0
measure: Balance confidence scores as measured by the Activities-specific Balance Confidence Scale
timeFrame: week 10
measure: Quality of life score as measured by the 12-item Short Form Health Survey
timeFrame: week 0
measure: Quality of life score as measured by the 12-item Short Form Health Survey
timeFrame: week 10
measure: Level of activity participation as measured by the Frenchay Activities Index
timeFrame: week 0
measure: Level of activity participation as measured by the Frenchay Activities Index
timeFrame: Week 10
measure: Level of perceived environmental barriers as measured by the Craig Hospital Inventory of Environmental Factors
timeFrame: week 0
measure: Level of perceived environmental barriers as measured by the Craig Hospital Inventory of Environmental Factors
timeFrame: week 10
measure: Ankle spasticity score as measured by the Modified Ashworth Scale
timeFrame: week 0
measure: Ankle spasticity score as measured by the Modified Ashworth Scale
timeFrame: week 10
Other outcomes:
Locations:
city: Hung Hom
country: Hong Kong
facility: The Hong Kong Polytechnic University
state: Kowloon
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Marco YC Pang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.