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The Effects of WBV on Muscle Stiffness and Reflex Activity in Stroke.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03015545
Recruitment Status : Completed
First Posted : January 10, 2017
Last Update Posted : December 10, 2018
Sponsor:
Information provided by (Responsible Party):
Marco Yiu-Chung Pang, The Hong Kong Polytechnic University

Tracking Information
First Submitted Date  ICMJE December 29, 2016
First Posted Date  ICMJE January 10, 2017
Last Update Posted Date December 10, 2018
Actual Study Start Date  ICMJE May 1, 2017
Actual Primary Completion Date September 3, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2018)
  • H-reflex of paretic soleus muscle [ Time Frame: Immediately before the intervention ]
    To measure the efficacy of synaptic transmission
  • H-reflex of paretic soleus muscle [ Time Frame: 1st minute after the intervention ]
    To measure the efficacy of synaptic transmission
  • H-reflex of paretic soleus muscle [ Time Frame: 2nd minute after the intervention ]
    To measure the efficacy of synaptic transmission
  • H-reflex of paretic soleus muscle [ Time Frame: 3rd minute after the intervention ]
    To measure the efficacy of synaptic transmission
  • H-reflex of paretic soleus muscle [ Time Frame: 4th minute after the intervention ]
    To measure the efficacy of synaptic transmission
  • H-reflex of paretic soleus muscle [ Time Frame: 5th minute after the intervention ]
    To measure the efficacy of synaptic transmission
  • Muscle stiffness of paretic medial gastrocnemius [ Time Frame: Immediately before the intervention ]
    Measured by Supersonic elastography with ankle in neutral position
  • Muscle stiffness of paretic medial gastrocnemius [ Time Frame: 1st minute after the intervention ]
    Measured by Supersonic elastography with ankle in neutral position
  • Muscle stiffness of paretic medial gastrocnemius [ Time Frame: 2nd minute after the intervention ]
    Measured by Supersonic elastography with ankle in neutral position
  • Muscle stiffness of paretic medial gastrocnemius [ Time Frame: 3rd minute after the intervention ]
    Measured by Supersonic elastography with ankle in neutral position
  • Muscle stiffness of paretic medial gastrocnemius [ Time Frame: 4th minute after the intervention ]
    Measured by Supersonic elastography with ankle in neutral position
  • Muscle stiffness of paretic medial gastrocnemius [ Time Frame: 5th minute after the intervention ]
    Measured by Supersonic elastography with ankle in neutral position
  • H-reflex of non-paretic soleus muscle [ Time Frame: Immediately before the intervention ]
    To measure the efficacy of synaptic transmission
  • H-reflex of non-paretic soleus muscle [ Time Frame: 1st minute after the intervention ]
    To measure the efficacy of synaptic transmission
  • H-reflex of non-paretic soleus muscle [ Time Frame: 2nd minute after the intervention ]
    To measure the efficacy of synaptic transmission
  • H-reflex of non-paretic soleus muscle [ Time Frame: 3rd minute after the intervention ]
    To measure the efficacy of synaptic transmission
  • H-reflex of non-paretic soleus muscle [ Time Frame: 4th minute after the intervention ]
    To measure the efficacy of synaptic transmission
  • H-reflex of non-paretic soleus muscle [ Time Frame: 5th minute after the intervention ]
    To measure the efficacy of synaptic transmission
  • Muscle stiffness of non-paretic medial gastrocnemius [ Time Frame: Immediately before the intervention ]
    Measured by Supersonic elastography with ankle in neutral position
  • Muscle stiffness of non-paretic medial gastrocnemius [ Time Frame: 1st minute after the intervention ]
    Measured by Supersonic elastography with ankle in neutral position
  • Muscle stiffness of non-paretic medial gastrocnemius [ Time Frame: 2nd minute after the intervention ]
    Measured by Supersonic elastography with ankle in neutral position
  • Muscle stiffness of non-paretic medial gastrocnemius [ Time Frame: 3th minute after the intervention ]
    Measured by Supersonic elastography with ankle in neutral position
  • Muscle stiffness of non-paretic medial gastrocnemius [ Time Frame: 4th minute after the intervention ]
    Measured by Supersonic elastography with ankle in neutral position
  • Muscle stiffness of non-paretic medial gastrocnemius [ Time Frame: 5th minute after the intervention ]
    Measured by Supersonic elastography with ankle in neutral position
Original Primary Outcome Measures  ICMJE
 (submitted: January 6, 2017)
  • H-reflex of paretic soleus muscle [ Time Frame: Immediately before the intervention ]
    To measure the efficacy of synaptic transmission
  • H-reflex of paretic soleus muscle [ Time Frame: Immediately after the intervention ]
    To measure the efficacy of synaptic transmission
  • H-reflex of paretic soleus muscle [ Time Frame: 1 minute after the intervention ]
    To measure the efficacy of synaptic transmission
  • H-reflex of paretic soleus muscle [ Time Frame: 2 minutes after the intervention ]
    To measure the efficacy of synaptic transmission
  • H-reflex of paretic soleus muscle [ Time Frame: 3 minutes after the intervention ]
    To measure the efficacy of synaptic transmission
  • Muscle elasticity of paretic medial gastrocnemius [ Time Frame: Immediately before the intervention ]
    Measured by Supersonic elstography with ankle in neutral position
  • Muscle elasticity of paretic medial gastrocnemius [ Time Frame: Immediately after the intervention ]
    Measured by Supersonic elstography with ankle in neutral position
  • Muscle elasticity of paretic medial gastrocnemius [ Time Frame: 1 minutes after the intervention ]
    Measured by Supersonic elstography with ankle in neutral position
  • Muscle elasticity of paretic medial gastrocnemius [ Time Frame: 2 minutes after the intervention ]
    Measured by Supersonic elstography with ankle in neutral position
  • Muscle elasticity of paretic medial gastrocnemius [ Time Frame: 3 minutes after the intervention ]
    Measured by Supersonic elstography with ankle in neutral position
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2018)
  • Intramuscular blood perfusion of paretic medial gastrocnemius muscle [ Time Frame: Immediately before the intervention ]
    Measured by power Doppler ultrasound
  • Intramuscular blood perfusion of paretic medial gastrocnemius muscle [ Time Frame: 1 minute after the intervention ]
    Measured by power Doppler ultrasound
  • Intramuscular blood perfusion of paretic medial gastrocnemius muscle [ Time Frame: 2nd minute after the intervention ]
    Measured by power Doppler ultrasound
  • Intramuscular blood perfusion of paretic medial gastrocnemius muscle [ Time Frame: 3rd minute after the intervention ]
    Measured by power Doppler ultrasound
  • Intramuscular blood perfusion of paretic medial gastrocnemius muscle [ Time Frame: 4th minute after the intervention ]
    Measured by power Doppler ultrasound
  • Intramuscular blood perfusion of paretic medial gastrocnemius muscle [ Time Frame: 5th minute after the intervention ]
    Measured by power Doppler ultrasound
  • Intramuscular blood perfusion of non-paretic medial gastrocnemius muscle [ Time Frame: Immediately before the intervention ]
    Measured by power Doppler ultrasound
  • Intramuscular blood perfusion of non-paretic medial gastrocnemius muscle [ Time Frame: 1th minute after the intervention ]
    Measured by power Doppler ultrasound
  • Intramuscular blood perfusion of non-paretic medial gastrocnemius muscle [ Time Frame: 2nd minute after the intervention ]
    Measured by power Doppler ultrasound
  • Intramuscular blood perfusion of non-paretic medial gastrocnemius muscle [ Time Frame: 3rd minute after the intervention ]
    Measured by power Doppler ultrasound
  • MoviIntramuscular blood perfusion of non-paretic medial gastrocnemius muscle [ Time Frame: 4th minute after the intervention ]
    Measured by power Doppler ultrasound
  • Intramuscular blood perfusion of non-paretic medial gastrocnemius muscle [ Time Frame: 5th minute after the intervention ]
    Measured by power Doppler ultrasound
Original Secondary Outcome Measures  ICMJE
 (submitted: January 6, 2017)
  • H-reflex of paretic flexor carpi radialis [ Time Frame: Immediately before the intervention ]
    To measure the efficacy of synaptic transmission
  • H-reflex of paretic flexor carpi radialis [ Time Frame: Immediately after the intervention ]
    To measure the efficacy of synaptic transmission
  • H-reflex of paretic flexor carpi radialis [ Time Frame: 1 minute after the intervention ]
    To measure the efficacy of synaptic transmission
  • H-reflex of paretic flexor carpi radialis [ Time Frame: 2 minutes after the intervention ]
    To measure the efficacy of synaptic transmission
  • H-reflex of paretic flexor carpi radialis [ Time Frame: 3 minutes after the intervention ]
    To measure the efficacy of synaptic transmission
  • Blood flow velocity of paretic side popliteal artery [ Time Frame: Immediately before the intervention ]
    Measured by spectral Doppler Ultrasound
  • Blood flow velocity of paretic side popliteal artery [ Time Frame: Immediately after the intervention ]
    Measured by spectral Doppler Ultrasound
  • Blood flow velocity of paretic side popliteal artery [ Time Frame: 1 minute after the intervention ]
    Measured by spectral Doppler Ultrasound
  • Blood flow velocity of paretic side popliteal artery [ Time Frame: 2 minutes after the intervention ]
    Measured by spectral Doppler Ultrasound
  • Blood flow velocity of paretic side popliteal artery [ Time Frame: 3 minutes after the intervention ]
    Measured by spectral Doppler Ultrasound
  • Moving Blood volume of paretic medial gastrocnemius muscle [ Time Frame: Immediately before the intervention ]
    Measured by power Doppler ultrasound
  • Moving Blood volume of paretic medial gastrocnemius muscle [ Time Frame: Immediately after the intervention ]
    Measured by power Doppler ultrasound
  • Moving Blood volume of paretic medial gastrocnemius muscle [ Time Frame: 1 minute after the intervention ]
    Measured by power Doppler ultrasound
  • Moving Blood volume of paretic medial gastrocnemius muscle [ Time Frame: 2 minutes after the intervention ]
    Measured by power Doppler ultrasound
  • Moving Blood volume of paretic medial gastrocnemius muscle [ Time Frame: 3 minutes after the intervention ]
    Measured by power Doppler ultrasound
Current Other Pre-specified Outcome Measures
 (submitted: April 24, 2017)
  • Fugl-Meyer Assessment of Motor Recovery after Stroke--lower extremities [ Time Frame: Immediately before the intervention ]
    Evaluates and measures motor recovery in post-stroke hemiplegic patients
  • Brief Balance Evaluation Systems Test [ Time Frame: Immediately before the intervention ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of WBV on Muscle Stiffness and Reflex Activity in Stroke.
Official Title  ICMJE The Effects of Whole Body Vibration (WBV) on Muscle Stiffness and Reflex Activity in People After Stroke.
Brief Summary Spastic hypertonia is common after stroke. Whole-body vibration (WBV) is known to have modulatory effects of muscle reflex activity and blood flow in other populations and thus have potential applications in the management of spastic hypertonia post-stroke. This study aims to investigate the acute effect of WBV on leg muscle H-reflex, stiffness, and blood perfusion in people with chronic stroke.
Detailed Description

Spastic hypertonia is common after stroke. Whole-body vibration (WBV) is known to have modulatory effects of muscle reflex activity and blood flow in other populations and thus have potential applications in management of spastic hypertonia post-stroke. However, the potential effects of WBV on leg muscle stiffness in stroke rehabilitation remains unknown. Scientific evidence is warranted to fill the knowledge gap.

Purpose This study aims to investigate the acute effect of WBV on leg muscle H-reflex, stiffness and blood perfusion in people with chronic stroke.

Methods Individuals with chronic stroke will be recruited from community self-help groups and existing patient database. Relevant information (e.g. demographic information, medical history) will be obtained from medical records and subject interviews. Each subject will have to fulfill the following inclusion criteria: (1) diagnosis of chronic stroke, (2) community-dwelling, (3) able to follow simple verbal instructions. Exclusion criteria are: (1) other diagnoses of neurological conditions, (2) significant musculoskeletal conditions (e.g. amputations), (3) metal implants in the lower extremity or spine, (4) recent fracture in the lower extremity, (5) diagnosis of osteoporosis, (6) vestibular disorders, (7) peripheral vascular disease, and (11) other serious illnesses or contraindications to exercise.

This is a single-blinded randomized within-patient cross-over study. Each participant was evaluated for the soleus H-reflex, stiffness and blood perfusion of the medial gastrocnemius (MG) using ultrasound on both sides before and after either a 5-minute WBV intervention (30 Hertz, 1.5mm, knee flexed 60 degrees) or a no-WBV condition (5 minutes). The measurements were performed at baseline and every 1-min post-intervention up to 5 minutes. The outcomes generated included the soleus H/M ratio, shear modulus and vascular index (VI) of the MG muscle.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Stroke
Intervention  ICMJE
  • Device: paretic leg-control
    standing on the vibration platform, with no vibration signals delivered.
  • Device: paretic leg-WBV
    standing on the vibration platform, with WBV at 30Hz, 1.5mm.
  • Device: non-paretic leg-control
    standing on the vibration platform, with no vibration signals delivered.
  • Device: non-paretic leg-WBV
    standing on the vibration platform, with WBV at 30Hz, 1.5mm.
Study Arms  ICMJE
  • Active Comparator: Control
    This group will stand with knee flexion 60 degrees on the same vibration platform for 60 seconds for 5 times with 60-seconds rest interval, but no vibration will be given.
    Interventions:
    • Device: paretic leg-control
    • Device: non-paretic leg-control
  • Active Comparator: High intensity whole body vibration
    This group will stand with knee flexion 60 degrees on the same vibration platform for 60 seconds for 5 times with 60-seconds rest interval. The whole body vibration platform will be set with frequency at 30Hz and amplitude at 1.5mm.
    Interventions:
    • Device: paretic leg-WBV
    • Device: non-paretic leg-WBV
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 7, 2018)
36
Original Estimated Enrollment  ICMJE
 (submitted: January 6, 2017)
42
Actual Study Completion Date  ICMJE December 31, 2017
Actual Primary Completion Date September 3, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Adult with a diagnosis of a hemispheric stroke >6 months,
  2. Medically stable,
  3. Able to stand independently for at least 1 minute and
  4. Mas score >1 measured at the ankle plantar flexors.

Exclusion Criteria:

  1. Brainstem or cerebellar stroke,
  2. Other neurological condition,
  3. Serious musculoskeletal or cardiovascular disease,
  4. Severe contracture of the ankle that the cannot be put in the neutral position.
  5. Metal implants or recent fractures in the lower extremities or spine,
  6. Fresh skin wound in lower extremities, especially popliteal fossa
  7. Other severe illnesses or contraindication for exercise.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03015545
Other Study ID Numbers  ICMJE HSEARS20161117007
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Marco Yiu-Chung Pang, The Hong Kong Polytechnic University
Study Sponsor  ICMJE The Hong Kong Polytechnic University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Hector WH Tsang, PhD Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
PRS Account The Hong Kong Polytechnic University
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP