An interventional study of paretic leg-control and paretic leg-WBV in Stroke, sponsored by The Hong Kong Polytechnic University. Completed at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-10.
Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Treatment
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.
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 36 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
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Exclusion Criteria:
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 · Device: non-paretic leg-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. The whole body vibration platform will be set with frequency at 30Hz and amplitude at 1.5mm.
Device: paretic leg-WBV · Device: non-paretic leg-WBV
standing on the vibration platform, with no vibration signals delivered.
standing on the vibration platform, with WBV at 30Hz, 1.5mm.
standing on the vibration platform, with no vibration signals delivered.
standing on the vibration platform, with WBV at 30Hz, 1.5mm.
H-reflex of paretic soleus muscle
To measure the efficacy of synaptic transmission
Time frame: Immediately before the intervention
H-reflex of paretic soleus muscle
To measure the efficacy of synaptic transmission
Time frame: 1st minute after the intervention
H-reflex of paretic soleus muscle
To measure the efficacy of synaptic transmission
Time frame: 2nd minute after the intervention
H-reflex of paretic soleus muscle
To measure the efficacy of synaptic transmission
Time frame: 3rd minute after the intervention
H-reflex of paretic soleus muscle
To measure the efficacy of synaptic transmission
Time frame: 4th minute after the intervention
H-reflex of paretic soleus muscle
To measure the efficacy of synaptic transmission
Time frame: 5th minute after the intervention
Muscle stiffness of paretic medial gastrocnemius
Measured by Supersonic elastography with ankle in neutral position
Time frame: Immediately before the intervention
Muscle stiffness of paretic medial gastrocnemius
Measured by Supersonic elastography with ankle in neutral position
Time frame: 1st minute after the intervention
Muscle stiffness of paretic medial gastrocnemius
Measured by Supersonic elastography with ankle in neutral position
Time frame: 2nd minute after the intervention
Muscle stiffness of paretic medial gastrocnemius
Measured by Supersonic elastography with ankle in neutral position
Time frame: 3rd minute after the intervention
Muscle stiffness of paretic medial gastrocnemius
Measured by Supersonic elastography with ankle in neutral position
Time frame: 4th minute after the intervention
Muscle stiffness of paretic medial gastrocnemius
Measured by Supersonic elastography with ankle in neutral position
Time frame: 5th minute after the intervention
H-reflex of non-paretic soleus muscle
To measure the efficacy of synaptic transmission
Time frame: Immediately before the intervention
H-reflex of non-paretic soleus muscle
To measure the efficacy of synaptic transmission
Time frame: 1st minute after the intervention
H-reflex of non-paretic soleus muscle
To measure the efficacy of synaptic transmission
Time frame: 2nd minute after the intervention
H-reflex of non-paretic soleus muscle
To measure the efficacy of synaptic transmission
Time frame: 3rd minute after the intervention
H-reflex of non-paretic soleus muscle
To measure the efficacy of synaptic transmission
Time frame: 4th minute after the intervention
H-reflex of non-paretic soleus muscle
To measure the efficacy of synaptic transmission
Time frame: 5th minute after the intervention
Muscle stiffness of non-paretic medial gastrocnemius
Measured by Supersonic elastography with ankle in neutral position
Time frame: Immediately before the intervention
Muscle stiffness of non-paretic medial gastrocnemius
Measured by Supersonic elastography with ankle in neutral position
Time frame: 1st minute after the intervention
Muscle stiffness of non-paretic medial gastrocnemius
Measured by Supersonic elastography with ankle in neutral position
Time frame: 2nd minute after the intervention
Muscle stiffness of non-paretic medial gastrocnemius
Measured by Supersonic elastography with ankle in neutral position
Time frame: 3th minute after the intervention
Muscle stiffness of non-paretic medial gastrocnemius
Measured by Supersonic elastography with ankle in neutral position
Time frame: 4th minute after the intervention
Muscle stiffness of non-paretic medial gastrocnemius
Measured by Supersonic elastography with ankle in neutral position
Time frame: 5th minute after the intervention
Intramuscular blood perfusion of paretic medial gastrocnemius muscle
Measured by power Doppler ultrasound
Time frame: Immediately before the intervention
Intramuscular blood perfusion of paretic medial gastrocnemius muscle
Measured by power Doppler ultrasound
Time frame: 1 minute after the intervention
Intramuscular blood perfusion of paretic medial gastrocnemius muscle
Measured by power Doppler ultrasound
Time frame: 2nd minute after the intervention
Intramuscular blood perfusion of paretic medial gastrocnemius muscle
Measured by power Doppler ultrasound
Time frame: 3rd minute after the intervention
Intramuscular blood perfusion of paretic medial gastrocnemius muscle
Measured by power Doppler ultrasound
Time frame: 4th minute after the intervention
Intramuscular blood perfusion of paretic medial gastrocnemius muscle
Measured by power Doppler ultrasound
Time frame: 5th minute after the intervention
Intramuscular blood perfusion of non-paretic medial gastrocnemius muscle
Measured by power Doppler ultrasound
Time frame: Immediately before the intervention
Intramuscular blood perfusion of non-paretic medial gastrocnemius muscle
Measured by power Doppler ultrasound
Time frame: 1th minute after the intervention
Intramuscular blood perfusion of non-paretic medial gastrocnemius muscle
Measured by power Doppler ultrasound
Time frame: 2nd minute after the intervention
Intramuscular blood perfusion of non-paretic medial gastrocnemius muscle
Measured by power Doppler ultrasound
Time frame: 3rd minute after the intervention
MoviIntramuscular blood perfusion of non-paretic medial gastrocnemius muscle
Measured by power Doppler ultrasound
Time frame: 4th minute after the intervention
Intramuscular blood perfusion of non-paretic medial gastrocnemius muscle
Measured by power Doppler ultrasound
Time frame: 5th minute after the intervention
Fugl-Meyer Assessment of Motor Recovery after Stroke--lower extremities
Evaluates and measures motor recovery in post-stroke hemiplegic patients
Time frame: Immediately before the intervention
Brief Balance Evaluation Systems Test
Time frame: Immediately before the intervention
Plan to share: No
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The Hong Kong Polytechnic University