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

December 7, 2018 updated by: Marco Yiu-Chung Pang, The Hong Kong Polytechnic University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
H-reflex of paretic soleus muscle
Time Frame: Immediately before the intervention
To measure the efficacy of synaptic transmission
Immediately before the intervention
H-reflex of paretic soleus muscle
Time Frame: 1st minute after the intervention
To measure the efficacy of synaptic transmission
1st minute after the intervention
H-reflex of paretic soleus muscle
Time Frame: 2nd minute after the intervention
To measure the efficacy of synaptic transmission
2nd minute after the intervention
H-reflex of paretic soleus muscle
Time Frame: 3rd minute after the intervention
To measure the efficacy of synaptic transmission
3rd minute after the intervention
H-reflex of paretic soleus muscle
Time Frame: 4th minute after the intervention
To measure the efficacy of synaptic transmission
4th minute after the intervention
H-reflex of paretic soleus muscle
Time Frame: 5th minute after the intervention
To measure the efficacy of synaptic transmission
5th minute after the intervention
Muscle stiffness of paretic medial gastrocnemius
Time Frame: Immediately before the intervention
Measured by Supersonic elastography with ankle in neutral position
Immediately before the intervention
Muscle stiffness of paretic medial gastrocnemius
Time Frame: 1st minute after the intervention
Measured by Supersonic elastography with ankle in neutral position
1st minute after the intervention
Muscle stiffness of paretic medial gastrocnemius
Time Frame: 2nd minute after the intervention
Measured by Supersonic elastography with ankle in neutral position
2nd minute after the intervention
Muscle stiffness of paretic medial gastrocnemius
Time Frame: 3rd minute after the intervention
Measured by Supersonic elastography with ankle in neutral position
3rd minute after the intervention
Muscle stiffness of paretic medial gastrocnemius
Time Frame: 4th minute after the intervention
Measured by Supersonic elastography with ankle in neutral position
4th minute after the intervention
Muscle stiffness of paretic medial gastrocnemius
Time Frame: 5th minute after the intervention
Measured by Supersonic elastography with ankle in neutral position
5th minute after the intervention
H-reflex of non-paretic soleus muscle
Time Frame: Immediately before the intervention
To measure the efficacy of synaptic transmission
Immediately before the intervention
H-reflex of non-paretic soleus muscle
Time Frame: 1st minute after the intervention
To measure the efficacy of synaptic transmission
1st minute after the intervention
H-reflex of non-paretic soleus muscle
Time Frame: 2nd minute after the intervention
To measure the efficacy of synaptic transmission
2nd minute after the intervention
H-reflex of non-paretic soleus muscle
Time Frame: 3rd minute after the intervention
To measure the efficacy of synaptic transmission
3rd minute after the intervention
H-reflex of non-paretic soleus muscle
Time Frame: 4th minute after the intervention
To measure the efficacy of synaptic transmission
4th minute after the intervention
H-reflex of non-paretic soleus muscle
Time Frame: 5th minute after the intervention
To measure the efficacy of synaptic transmission
5th minute after the intervention
Muscle stiffness of non-paretic medial gastrocnemius
Time Frame: Immediately before the intervention
Measured by Supersonic elastography with ankle in neutral position
Immediately before the intervention
Muscle stiffness of non-paretic medial gastrocnemius
Time Frame: 1st minute after the intervention
Measured by Supersonic elastography with ankle in neutral position
1st minute after the intervention
Muscle stiffness of non-paretic medial gastrocnemius
Time Frame: 2nd minute after the intervention
Measured by Supersonic elastography with ankle in neutral position
2nd minute after the intervention
Muscle stiffness of non-paretic medial gastrocnemius
Time Frame: 3th minute after the intervention
Measured by Supersonic elastography with ankle in neutral position
3th minute after the intervention
Muscle stiffness of non-paretic medial gastrocnemius
Time Frame: 4th minute after the intervention
Measured by Supersonic elastography with ankle in neutral position
4th minute after the intervention
Muscle stiffness of non-paretic medial gastrocnemius
Time Frame: 5th minute after the intervention
Measured by Supersonic elastography with ankle in neutral position
5th minute after the intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Intramuscular blood perfusion of paretic medial gastrocnemius muscle
Time Frame: Immediately before the intervention
Measured by power Doppler ultrasound
Immediately before the intervention
Intramuscular blood perfusion of paretic medial gastrocnemius muscle
Time Frame: 1 minute after the intervention
Measured by power Doppler ultrasound
1 minute after the intervention
Intramuscular blood perfusion of paretic medial gastrocnemius muscle
Time Frame: 2nd minute after the intervention
Measured by power Doppler ultrasound
2nd minute after the intervention
Intramuscular blood perfusion of paretic medial gastrocnemius muscle
Time Frame: 3rd minute after the intervention
Measured by power Doppler ultrasound
3rd minute after the intervention
Intramuscular blood perfusion of paretic medial gastrocnemius muscle
Time Frame: 4th minute after the intervention
Measured by power Doppler ultrasound
4th minute after the intervention
Intramuscular blood perfusion of paretic medial gastrocnemius muscle
Time Frame: 5th minute after the intervention
Measured by power Doppler ultrasound
5th minute after the intervention
Intramuscular blood perfusion of non-paretic medial gastrocnemius muscle
Time Frame: Immediately before the intervention
Measured by power Doppler ultrasound
Immediately before the intervention
Intramuscular blood perfusion of non-paretic medial gastrocnemius muscle
Time Frame: 1th minute after the intervention
Measured by power Doppler ultrasound
1th minute after the intervention
Intramuscular blood perfusion of non-paretic medial gastrocnemius muscle
Time Frame: 2nd minute after the intervention
Measured by power Doppler ultrasound
2nd minute after the intervention
Intramuscular blood perfusion of non-paretic medial gastrocnemius muscle
Time Frame: 3rd minute after the intervention
Measured by power Doppler ultrasound
3rd minute after the intervention
MoviIntramuscular blood perfusion of non-paretic medial gastrocnemius muscle
Time Frame: 4th minute after the intervention
Measured by power Doppler ultrasound
4th minute after the intervention
Intramuscular blood perfusion of non-paretic medial gastrocnemius muscle
Time Frame: 5th minute after the intervention
Measured by power Doppler ultrasound
5th minute after the intervention

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Immediately before the intervention
Brief Balance Evaluation Systems Test
Time Frame: Immediately before the intervention
Immediately before the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hong Kong Polytechnic University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Hector WH Tsang, PhD, Department of Rehabilitation Sciences, The Hong Kong Polytechnic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 3, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 29, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2017

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 10, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 10, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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