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

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

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: paretic leg-control; Device: non-paretic leg-control; Device: paretic leg-WBV; Device: non-paretic leg-WBV

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: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Kowloon
    • Hung Hom, Kowloon, Hong Kong
      • The Hong Kong Polytechnic University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
H-reflex of paretic soleus muscle	To measure the efficacy of synaptic transmission	Immediately before the intervention
H-reflex of paretic soleus muscle	To measure the efficacy of synaptic transmission	1st minute after the intervention
H-reflex of paretic soleus muscle	To measure the efficacy of synaptic transmission	2nd minute after the intervention
H-reflex of paretic soleus muscle	To measure the efficacy of synaptic transmission	3rd minute after the intervention
H-reflex of paretic soleus muscle	To measure the efficacy of synaptic transmission	4th minute after the intervention
H-reflex of paretic soleus muscle	To measure the efficacy of synaptic transmission	5th minute after the intervention
Muscle stiffness of paretic medial gastrocnemius	Measured by Supersonic elastography with ankle in neutral position	Immediately before the intervention
Muscle stiffness of paretic medial gastrocnemius	Measured by Supersonic elastography with ankle in neutral position	1st minute after the intervention
Muscle stiffness of paretic medial gastrocnemius	Measured by Supersonic elastography with ankle in neutral position	2nd minute after the intervention
Muscle stiffness of paretic medial gastrocnemius	Measured by Supersonic elastography with ankle in neutral position	3rd minute after the intervention
Muscle stiffness of paretic medial gastrocnemius	Measured by Supersonic elastography with ankle in neutral position	4th minute after the intervention
Muscle stiffness of paretic medial gastrocnemius	Measured by Supersonic elastography with ankle in neutral position	5th minute after the intervention
H-reflex of non-paretic soleus muscle	To measure the efficacy of synaptic transmission	Immediately before the intervention
H-reflex of non-paretic soleus muscle	To measure the efficacy of synaptic transmission	1st minute after the intervention
H-reflex of non-paretic soleus muscle	To measure the efficacy of synaptic transmission	2nd minute after the intervention
H-reflex of non-paretic soleus muscle	To measure the efficacy of synaptic transmission	3rd minute after the intervention
H-reflex of non-paretic soleus muscle	To measure the efficacy of synaptic transmission	4th minute after the intervention
H-reflex of non-paretic soleus muscle	To measure the efficacy of synaptic transmission	5th minute after the intervention
Muscle stiffness of non-paretic medial gastrocnemius	Measured by Supersonic elastography with ankle in neutral position	Immediately before the intervention
Muscle stiffness of non-paretic medial gastrocnemius	Measured by Supersonic elastography with ankle in neutral position	1st minute after the intervention
Muscle stiffness of non-paretic medial gastrocnemius	Measured by Supersonic elastography with ankle in neutral position	2nd minute after the intervention
Muscle stiffness of non-paretic medial gastrocnemius	Measured by Supersonic elastography with ankle in neutral position	3th minute after the intervention
Muscle stiffness of non-paretic medial gastrocnemius	Measured by Supersonic elastography with ankle in neutral position	4th minute after the intervention
Muscle stiffness of non-paretic medial gastrocnemius	Measured by Supersonic elastography with ankle in neutral position	5th minute after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intramuscular blood perfusion of paretic medial gastrocnemius muscle	Measured by power Doppler ultrasound	Immediately before the intervention
Intramuscular blood perfusion of paretic medial gastrocnemius muscle	Measured by power Doppler ultrasound	1 minute after the intervention
Intramuscular blood perfusion of paretic medial gastrocnemius muscle	Measured by power Doppler ultrasound	2nd minute after the intervention
Intramuscular blood perfusion of paretic medial gastrocnemius muscle	Measured by power Doppler ultrasound	3rd minute after the intervention
Intramuscular blood perfusion of paretic medial gastrocnemius muscle	Measured by power Doppler ultrasound	4th minute after the intervention
Intramuscular blood perfusion of paretic medial gastrocnemius muscle	Measured by power Doppler ultrasound	5th minute after the intervention
Intramuscular blood perfusion of non-paretic medial gastrocnemius muscle	Measured by power Doppler ultrasound	Immediately before the intervention
Intramuscular blood perfusion of non-paretic medial gastrocnemius muscle	Measured by power Doppler ultrasound	1th minute after the intervention
Intramuscular blood perfusion of non-paretic medial gastrocnemius muscle	Measured by power Doppler ultrasound	2nd minute after the intervention
Intramuscular blood perfusion of non-paretic medial gastrocnemius muscle	Measured by power Doppler ultrasound	3rd minute after the intervention
MoviIntramuscular blood perfusion of non-paretic medial gastrocnemius muscle	Measured by power Doppler ultrasound	4th minute after the intervention
Intramuscular blood perfusion of non-paretic medial gastrocnemius muscle	Measured by power Doppler ultrasound	5th minute after the intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl-Meyer Assessment of Motor Recovery after Stroke--lower extremities	Evaluates and measures motor recovery in post-stroke hemiplegic patients	Immediately before the intervention
Brief Balance Evaluation Systems Test		Immediately before the intervention

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Investigators: Study Chair: Hector WH Tsang, PhD, Department of Rehabilitation Sciences, The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2017
• Primary Completion (ACTUAL): September 3, 2017
• Study Completion (ACTUAL): December 31, 2017

Study Registration Dates

• First Submitted: December 29, 2016
• First Submitted That Met QC Criteria: January 6, 2017
• First Posted (ESTIMATE): January 10, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 10, 2018
• Last Update Submitted That Met QC Criteria: December 7, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: H-reflex; Whole body vibration; Ultrasound elastography; Muscle Stiffness; blood perfusion
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: HSEARS20161117007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No