NCT03015545

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 29, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 10, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

December 10, 2018

Status Verified

December 1, 2018

Enrollment Period

4 months

First QC Date

December 29, 2016

Last Update Submit

December 7, 2018

Conditions

Stroke

Keywords

Muscle StiffnessUltrasound elastographyH-reflexWhole body vibrationblood perfusion

Outcome Measures

Primary Outcomes (24)

  • 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 Outcomes (12)

  • Intramuscular blood perfusion of paretic medial gastrocnemius muscle

    Immediately before the intervention

  • Intramuscular blood perfusion of paretic medial gastrocnemius muscle

    1 minute after the intervention

  • Intramuscular blood perfusion of paretic medial gastrocnemius muscle

    2nd minute after the intervention

  • Intramuscular blood perfusion of paretic medial gastrocnemius muscle

    3rd minute after the intervention

  • Intramuscular blood perfusion of paretic medial gastrocnemius muscle

    4th minute after the intervention

  • +7 more secondary outcomes

Other Outcomes (2)

  • Fugl-Meyer Assessment of Motor Recovery after Stroke--lower extremities

    Immediately before the intervention

  • Brief Balance Evaluation Systems Test

    Immediately before the intervention

Study Arms (2)

Control

ACTIVE COMPARATOR

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-controlDevice: non-paretic leg-control

High intensity whole body vibration

ACTIVE COMPARATOR

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-WBVDevice: non-paretic leg-WBV

Interventions

paretic leg-controlDEVICE

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

Control
paretic leg-WBVDEVICE

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

High intensity whole body vibration
non-paretic leg-controlDEVICE

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

Control
non-paretic leg-WBVDEVICE

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

High intensity whole body vibration

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong Polytechnic University

Hung Hom, Kowloon, Hong Kong

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Hector WH Tsang, PhD

    Department of Rehabilitation Sciences, The Hong Kong Polytechnic University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 29, 2016

First Posted

January 10, 2017

Study Start

May 1, 2017

Primary Completion

September 3, 2017

Study Completion

December 31, 2017

Last Updated

December 10, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)