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Whole Body Vibration in Chronic Stroke

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by The Hong Kong Polytechnic University
Sponsor:
Information provided by (Responsible Party):
Marco Yiu-Chung Pang, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier:
NCT01822704
First received: March 28, 2013
Last updated: April 1, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Stroke
Device: Low intensity whole body vibration
Device: High intensity whole body vibration
Behavioral: Leg exercises

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Application of Vertical Whole Body Vibration in Stroke Patients: Neuromuscular Effects, and Clinical Efficacy

Resource links provided by NLM:


Further study details as provided by The Hong Kong Polytechnic University:

Primary Outcome Measures:
  • Isometric knee muscle strength [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
  • Isometric knee muscle strength [ Time Frame: week 10 ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 81
Study Start Date: March 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control
This group will undergo three 45-minute exercise sessions per week for 10 weeks. No whole body vibration will be given.
Behavioral: Leg exercises
Experimental: Low intensity vibration
This group will receive three 45-minute whole body vibration training sessions for 10 consecutive weeks. The vibration will be of low intensity (frequency: 20 Hertz, amplitude: 1mm).
Device: Low intensity whole body vibration Behavioral: Leg exercises
Experimental: High intensity vibration
This group will receive three 45-minute whole body vibration training sessions per week for 10 consecutive weeks.The vibration will be of higher intensity than the low intensity vibration group (frequency: 30 Hertz, amplitude: 1mm).
Device: High intensity whole body vibration Behavioral: Leg exercises

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01822704

Contacts
Contact: Marco YC Pang, PhD 852-2766-7156 Marco.Pang@polyu.edu.hk

Locations
Hong Kong
The Hong Kong Polytechnic University Recruiting
Hung Hom, Kowloon, Hong Kong
Contact: Alan Liao, MPT    852-2766-4845    lr-liao@126.com   
Principal Investigator: Marco Y Pang, PhD         
Sponsors and Collaborators
The Hong Kong Polytechnic University
Investigators
Principal Investigator: Marco YC Pang, PhD The Hong Kong Polytechnic University
  More Information

Publications:
Responsible Party: Marco Yiu-Chung Pang, Associate Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT01822704     History of Changes
Other Study ID Numbers: HSEARS20130209001
Study First Received: March 28, 2013
Last Updated: April 1, 2013
Health Authority: Hong Kong: The Hong Kong Polytechnic University

Keywords provided by The Hong Kong Polytechnic University:
Stroke
Exercise
Rehabilitation
Vibration

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014