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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

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.

Condition or disease Intervention/treatment Phase
Stroke Device: paretic leg-control Device: paretic leg-WBV Device: non-paretic leg-control Device: non-paretic leg-WBV Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Whole Body Vibration (WBV) on Muscle Stiffness and Reflex Activity in People After Stroke.
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : September 3, 2017
Actual Study Completion Date : December 31, 2017

Arm Intervention/treatment
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.
Device: paretic leg-control
standing on the vibration platform, with no vibration signals delivered.

Device: non-paretic leg-control
standing on the vibration platform, with no vibration signals delivered.

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.
Device: paretic leg-WBV
standing on the vibration platform, with WBV at 30Hz, 1.5mm.

Device: non-paretic leg-WBV
standing on the vibration platform, with WBV at 30Hz, 1.5mm.




Primary Outcome Measures :
  1. H-reflex of paretic soleus muscle [ Time Frame: Immediately before the intervention ]
    To measure the efficacy of synaptic transmission

  2. H-reflex of paretic soleus muscle [ Time Frame: 1st minute after the intervention ]
    To measure the efficacy of synaptic transmission

  3. H-reflex of paretic soleus muscle [ Time Frame: 2nd minute after the intervention ]
    To measure the efficacy of synaptic transmission

  4. H-reflex of paretic soleus muscle [ Time Frame: 3rd minute after the intervention ]
    To measure the efficacy of synaptic transmission

  5. H-reflex of paretic soleus muscle [ Time Frame: 4th minute after the intervention ]
    To measure the efficacy of synaptic transmission

  6. H-reflex of paretic soleus muscle [ Time Frame: 5th minute after the intervention ]
    To measure the efficacy of synaptic transmission

  7. Muscle stiffness of paretic medial gastrocnemius [ Time Frame: Immediately before the intervention ]
    Measured by Supersonic elastography with ankle in neutral position

  8. Muscle stiffness of paretic medial gastrocnemius [ Time Frame: 1st minute after the intervention ]
    Measured by Supersonic elastography with ankle in neutral position

  9. Muscle stiffness of paretic medial gastrocnemius [ Time Frame: 2nd minute after the intervention ]
    Measured by Supersonic elastography with ankle in neutral position

  10. Muscle stiffness of paretic medial gastrocnemius [ Time Frame: 3rd minute after the intervention ]
    Measured by Supersonic elastography with ankle in neutral position

  11. Muscle stiffness of paretic medial gastrocnemius [ Time Frame: 4th minute after the intervention ]
    Measured by Supersonic elastography with ankle in neutral position

  12. Muscle stiffness of paretic medial gastrocnemius [ Time Frame: 5th minute after the intervention ]
    Measured by Supersonic elastography with ankle in neutral position

  13. H-reflex of non-paretic soleus muscle [ Time Frame: Immediately before the intervention ]
    To measure the efficacy of synaptic transmission

  14. H-reflex of non-paretic soleus muscle [ Time Frame: 1st minute after the intervention ]
    To measure the efficacy of synaptic transmission

  15. H-reflex of non-paretic soleus muscle [ Time Frame: 2nd minute after the intervention ]
    To measure the efficacy of synaptic transmission

  16. H-reflex of non-paretic soleus muscle [ Time Frame: 3rd minute after the intervention ]
    To measure the efficacy of synaptic transmission

  17. H-reflex of non-paretic soleus muscle [ Time Frame: 4th minute after the intervention ]
    To measure the efficacy of synaptic transmission

  18. H-reflex of non-paretic soleus muscle [ Time Frame: 5th minute after the intervention ]
    To measure the efficacy of synaptic transmission

  19. Muscle stiffness of non-paretic medial gastrocnemius [ Time Frame: Immediately before the intervention ]
    Measured by Supersonic elastography with ankle in neutral position

  20. Muscle stiffness of non-paretic medial gastrocnemius [ Time Frame: 1st minute after the intervention ]
    Measured by Supersonic elastography with ankle in neutral position

  21. Muscle stiffness of non-paretic medial gastrocnemius [ Time Frame: 2nd minute after the intervention ]
    Measured by Supersonic elastography with ankle in neutral position

  22. Muscle stiffness of non-paretic medial gastrocnemius [ Time Frame: 3th minute after the intervention ]
    Measured by Supersonic elastography with ankle in neutral position

  23. Muscle stiffness of non-paretic medial gastrocnemius [ Time Frame: 4th minute after the intervention ]
    Measured by Supersonic elastography with ankle in neutral position

  24. Muscle stiffness of non-paretic medial gastrocnemius [ Time Frame: 5th minute after the intervention ]
    Measured by Supersonic elastography with ankle in neutral position


Secondary Outcome Measures :
  1. Intramuscular blood perfusion of paretic medial gastrocnemius muscle [ Time Frame: Immediately before the intervention ]
    Measured by power Doppler ultrasound

  2. Intramuscular blood perfusion of paretic medial gastrocnemius muscle [ Time Frame: 1 minute after the intervention ]
    Measured by power Doppler ultrasound

  3. Intramuscular blood perfusion of paretic medial gastrocnemius muscle [ Time Frame: 2nd minute after the intervention ]
    Measured by power Doppler ultrasound

  4. Intramuscular blood perfusion of paretic medial gastrocnemius muscle [ Time Frame: 3rd minute after the intervention ]
    Measured by power Doppler ultrasound

  5. Intramuscular blood perfusion of paretic medial gastrocnemius muscle [ Time Frame: 4th minute after the intervention ]
    Measured by power Doppler ultrasound

  6. Intramuscular blood perfusion of paretic medial gastrocnemius muscle [ Time Frame: 5th minute after the intervention ]
    Measured by power Doppler ultrasound

  7. Intramuscular blood perfusion of non-paretic medial gastrocnemius muscle [ Time Frame: Immediately before the intervention ]
    Measured by power Doppler ultrasound

  8. Intramuscular blood perfusion of non-paretic medial gastrocnemius muscle [ Time Frame: 1th minute after the intervention ]
    Measured by power Doppler ultrasound

  9. Intramuscular blood perfusion of non-paretic medial gastrocnemius muscle [ Time Frame: 2nd minute after the intervention ]
    Measured by power Doppler ultrasound

  10. Intramuscular blood perfusion of non-paretic medial gastrocnemius muscle [ Time Frame: 3rd minute after the intervention ]
    Measured by power Doppler ultrasound

  11. MoviIntramuscular blood perfusion of non-paretic medial gastrocnemius muscle [ Time Frame: 4th minute after the intervention ]
    Measured by power Doppler ultrasound

  12. Intramuscular blood perfusion of non-paretic medial gastrocnemius muscle [ Time Frame: 5th minute after the intervention ]
    Measured by power Doppler ultrasound


Other Outcome Measures:
  1. 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

  2. Brief Balance Evaluation Systems Test [ Time Frame: Immediately before the intervention ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03015545


Locations
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Hong Kong
The Hong Kong Polytechnic University
Hung Hom, Kowloon, Hong Kong
Sponsors and Collaborators
The Hong Kong Polytechnic University
Investigators
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Study Chair: Hector WH Tsang, PhD Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
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Responsible Party: Marco Yiu-Chung Pang, Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT03015545    
Other Study ID Numbers: HSEARS20161117007
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marco Yiu-Chung Pang, The Hong Kong Polytechnic University:
Muscle Stiffness
Ultrasound elastography
H-reflex
Whole body vibration
blood perfusion
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases