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Completed

NCT Number: NCT03015545

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hong Kong Polytechnic University

Hung Hom, Kowloon, Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Brainstem or cerebellar stroke,
  • Other neurological condition,
  • Serious musculoskeletal or cardiovascular disease,
  • Severe contracture of the ankle that the cannot be put in the neutral position.
  • Metal implants or recent fractures in the lower extremities or spine,
  • Fresh skin wound in lower extremities, especially popliteal fossa
  • Other severe illnesses or contraindication for exercise.

Treatment and study plan

paretic leg-control

Device

standing on the vibration platform, with no vibration signals delivered.

paretic leg-WBV

Device

standing on the vibration platform, with WBV at 30Hz, 1.5mm.

non-paretic leg-control

Device

standing on the vibration platform, with no vibration signals delivered.

non-paretic leg-WBV

Device

standing on the vibration platform, with WBV at 30Hz, 1.5mm.

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

The Effects of Whole Body Vibration (WBV) on Muscle Stiffness and Reflex Activity in People After Stroke.

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 10, 2017
Registry last updated
Dec 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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