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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
paretic leg-control
paretic leg-WBV
non-paretic leg-control
non-paretic leg-WBV
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Muscle Stiffness, Ultrasound elastography, H-reflex, Whole body vibration, blood perfusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Hong Kong Polytechnic University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Control

High intensity whole body vibration

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

H-reflex of paretic soleus muscle
To measure the efficacy of synaptic transmission
H-reflex of paretic soleus muscle
To measure the efficacy of synaptic transmission
H-reflex of paretic soleus muscle
To measure the efficacy of synaptic transmission
H-reflex of paretic soleus muscle
To measure the efficacy of synaptic transmission
H-reflex of paretic soleus muscle
To measure the efficacy of synaptic transmission
H-reflex of paretic soleus muscle
To measure the efficacy of synaptic transmission
Muscle stiffness of paretic medial gastrocnemius
Measured by Supersonic elastography with ankle in neutral position
Muscle stiffness of paretic medial gastrocnemius
Measured by Supersonic elastography with ankle in neutral position
Muscle stiffness of paretic medial gastrocnemius
Measured by Supersonic elastography with ankle in neutral position
Muscle stiffness of paretic medial gastrocnemius
Measured by Supersonic elastography with ankle in neutral position
Muscle stiffness of paretic medial gastrocnemius
Measured by Supersonic elastography with ankle in neutral position
Muscle stiffness of paretic medial gastrocnemius
Measured by Supersonic elastography with ankle in neutral position
H-reflex of non-paretic soleus muscle
To measure the efficacy of synaptic transmission
H-reflex of non-paretic soleus muscle
To measure the efficacy of synaptic transmission
H-reflex of non-paretic soleus muscle
To measure the efficacy of synaptic transmission
H-reflex of non-paretic soleus muscle
To measure the efficacy of synaptic transmission
H-reflex of non-paretic soleus muscle
To measure the efficacy of synaptic transmission
H-reflex of non-paretic soleus muscle
To measure the efficacy of synaptic transmission
Muscle stiffness of non-paretic medial gastrocnemius
Measured by Supersonic elastography with ankle in neutral position
Muscle stiffness of non-paretic medial gastrocnemius
Measured by Supersonic elastography with ankle in neutral position
Muscle stiffness of non-paretic medial gastrocnemius
Measured by Supersonic elastography with ankle in neutral position
Muscle stiffness of non-paretic medial gastrocnemius
Measured by Supersonic elastography with ankle in neutral position
Muscle stiffness of non-paretic medial gastrocnemius
Measured by Supersonic elastography with ankle in neutral position
Muscle stiffness of non-paretic medial gastrocnemius
Measured by Supersonic elastography with ankle in neutral position

Secondary Outcome Measures

Intramuscular blood perfusion of paretic medial gastrocnemius muscle
Measured by power Doppler ultrasound
Intramuscular blood perfusion of paretic medial gastrocnemius muscle
Measured by power Doppler ultrasound
Intramuscular blood perfusion of paretic medial gastrocnemius muscle
Measured by power Doppler ultrasound
Intramuscular blood perfusion of paretic medial gastrocnemius muscle
Measured by power Doppler ultrasound
Intramuscular blood perfusion of paretic medial gastrocnemius muscle
Measured by power Doppler ultrasound
Intramuscular blood perfusion of paretic medial gastrocnemius muscle
Measured by power Doppler ultrasound
Intramuscular blood perfusion of non-paretic medial gastrocnemius muscle
Measured by power Doppler ultrasound
Intramuscular blood perfusion of non-paretic medial gastrocnemius muscle
Measured by power Doppler ultrasound
Intramuscular blood perfusion of non-paretic medial gastrocnemius muscle
Measured by power Doppler ultrasound
Intramuscular blood perfusion of non-paretic medial gastrocnemius muscle
Measured by power Doppler ultrasound
MoviIntramuscular blood perfusion of non-paretic medial gastrocnemius muscle
Measured by power Doppler ultrasound
Intramuscular blood perfusion of non-paretic medial gastrocnemius muscle
Measured by power Doppler ultrasound

Full Information

First Posted
December 29, 2016
Last Updated
December 7, 2018
Sponsor
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT03015545
Brief Title
The Effects of WBV on Muscle Stiffness and Reflex Activity in Stroke.
Official Title
The Effects of Whole Body Vibration (WBV) on Muscle Stiffness and Reflex Activity in People After Stroke.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
September 3, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Muscle Stiffness, Ultrasound elastography, H-reflex, Whole body vibration, blood perfusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Arm Title
High intensity whole body vibration
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
paretic leg-control
Intervention Description
standing on the vibration platform, with no vibration signals delivered.
Intervention Type
Device
Intervention Name(s)
paretic leg-WBV
Intervention Description
standing on the vibration platform, with WBV at 30Hz, 1.5mm.
Intervention Type
Device
Intervention Name(s)
non-paretic leg-control
Intervention Description
standing on the vibration platform, with no vibration signals delivered.
Intervention Type
Device
Intervention Name(s)
non-paretic leg-WBV
Intervention Description
standing on the vibration platform, with WBV at 30Hz, 1.5mm.
Primary Outcome Measure Information:
Title
H-reflex of paretic soleus muscle
Description
To measure the efficacy of synaptic transmission
Time Frame
Immediately before the intervention
Title
H-reflex of paretic soleus muscle
Description
To measure the efficacy of synaptic transmission
Time Frame
1st minute after the intervention
Title
H-reflex of paretic soleus muscle
Description
To measure the efficacy of synaptic transmission
Time Frame
2nd minute after the intervention
Title
H-reflex of paretic soleus muscle
Description
To measure the efficacy of synaptic transmission
Time Frame
3rd minute after the intervention
Title
H-reflex of paretic soleus muscle
Description
To measure the efficacy of synaptic transmission
Time Frame
4th minute after the intervention
Title
H-reflex of paretic soleus muscle
Description
To measure the efficacy of synaptic transmission
Time Frame
5th minute after the intervention
Title
Muscle stiffness of paretic medial gastrocnemius
Description
Measured by Supersonic elastography with ankle in neutral position
Time Frame
Immediately before the intervention
Title
Muscle stiffness of paretic medial gastrocnemius
Description
Measured by Supersonic elastography with ankle in neutral position
Time Frame
1st minute after the intervention
Title
Muscle stiffness of paretic medial gastrocnemius
Description
Measured by Supersonic elastography with ankle in neutral position
Time Frame
2nd minute after the intervention
Title
Muscle stiffness of paretic medial gastrocnemius
Description
Measured by Supersonic elastography with ankle in neutral position
Time Frame
3rd minute after the intervention
Title
Muscle stiffness of paretic medial gastrocnemius
Description
Measured by Supersonic elastography with ankle in neutral position
Time Frame
4th minute after the intervention
Title
Muscle stiffness of paretic medial gastrocnemius
Description
Measured by Supersonic elastography with ankle in neutral position
Time Frame
5th minute after the intervention
Title
H-reflex of non-paretic soleus muscle
Description
To measure the efficacy of synaptic transmission
Time Frame
Immediately before the intervention
Title
H-reflex of non-paretic soleus muscle
Description
To measure the efficacy of synaptic transmission
Time Frame
1st minute after the intervention
Title
H-reflex of non-paretic soleus muscle
Description
To measure the efficacy of synaptic transmission
Time Frame
2nd minute after the intervention
Title
H-reflex of non-paretic soleus muscle
Description
To measure the efficacy of synaptic transmission
Time Frame
3rd minute after the intervention
Title
H-reflex of non-paretic soleus muscle
Description
To measure the efficacy of synaptic transmission
Time Frame
4th minute after the intervention
Title
H-reflex of non-paretic soleus muscle
Description
To measure the efficacy of synaptic transmission
Time Frame
5th minute after the intervention
Title
Muscle stiffness of non-paretic medial gastrocnemius
Description
Measured by Supersonic elastography with ankle in neutral position
Time Frame
Immediately before the intervention
Title
Muscle stiffness of non-paretic medial gastrocnemius
Description
Measured by Supersonic elastography with ankle in neutral position
Time Frame
1st minute after the intervention
Title
Muscle stiffness of non-paretic medial gastrocnemius
Description
Measured by Supersonic elastography with ankle in neutral position
Time Frame
2nd minute after the intervention
Title
Muscle stiffness of non-paretic medial gastrocnemius
Description
Measured by Supersonic elastography with ankle in neutral position
Time Frame
3th minute after the intervention
Title
Muscle stiffness of non-paretic medial gastrocnemius
Description
Measured by Supersonic elastography with ankle in neutral position
Time Frame
4th minute after the intervention
Title
Muscle stiffness of non-paretic medial gastrocnemius
Description
Measured by Supersonic elastography with ankle in neutral position
Time Frame
5th minute after the intervention
Secondary Outcome Measure Information:
Title
Intramuscular blood perfusion of paretic medial gastrocnemius muscle
Description
Measured by power Doppler ultrasound
Time Frame
Immediately before the intervention
Title
Intramuscular blood perfusion of paretic medial gastrocnemius muscle
Description
Measured by power Doppler ultrasound
Time Frame
1 minute after the intervention
Title
Intramuscular blood perfusion of paretic medial gastrocnemius muscle
Description
Measured by power Doppler ultrasound
Time Frame
2nd minute after the intervention
Title
Intramuscular blood perfusion of paretic medial gastrocnemius muscle
Description
Measured by power Doppler ultrasound
Time Frame
3rd minute after the intervention
Title
Intramuscular blood perfusion of paretic medial gastrocnemius muscle
Description
Measured by power Doppler ultrasound
Time Frame
4th minute after the intervention
Title
Intramuscular blood perfusion of paretic medial gastrocnemius muscle
Description
Measured by power Doppler ultrasound
Time Frame
5th minute after the intervention
Title
Intramuscular blood perfusion of non-paretic medial gastrocnemius muscle
Description
Measured by power Doppler ultrasound
Time Frame
Immediately before the intervention
Title
Intramuscular blood perfusion of non-paretic medial gastrocnemius muscle
Description
Measured by power Doppler ultrasound
Time Frame
1th minute after the intervention
Title
Intramuscular blood perfusion of non-paretic medial gastrocnemius muscle
Description
Measured by power Doppler ultrasound
Time Frame
2nd minute after the intervention
Title
Intramuscular blood perfusion of non-paretic medial gastrocnemius muscle
Description
Measured by power Doppler ultrasound
Time Frame
3rd minute after the intervention
Title
MoviIntramuscular blood perfusion of non-paretic medial gastrocnemius muscle
Description
Measured by power Doppler ultrasound
Time Frame
4th minute after the intervention
Title
Intramuscular blood perfusion of non-paretic medial gastrocnemius muscle
Description
Measured by power Doppler ultrasound
Time Frame
5th minute after the intervention
Other Pre-specified Outcome Measures:
Title
Fugl-Meyer Assessment of Motor Recovery after Stroke--lower extremities
Description
Evaluates and measures motor recovery in post-stroke hemiplegic patients
Time Frame
Immediately before the intervention
Title
Brief Balance Evaluation Systems Test
Time Frame
Immediately before the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hector WH Tsang, PhD
Organizational Affiliation
Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
Official's Role
Study Chair
Facility Information:
Facility Name
The Hong Kong Polytechnic University
City
Hung Hom
State/Province
Kowloon
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No

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

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