NCT02557711

Brief Summary

The aim of this study: 1. To evaluate the correlation between the clinic tools and ultrasound elastography/ ARFI imaging in stroke patients. 2. To assess the reliability of elastography/ ARFI imaging in spasticity evaluation of stroke patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 23, 2015

Completed
8 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

March 30, 2016

Status Verified

March 1, 2016

Enrollment Period

11 months

First QC Date

September 17, 2015

Last Update Submit

March 28, 2016

Conditions

Keywords

spasticitystrokeultrasound elastographyacoustic radiation force impulse

Outcome Measures

Primary Outcomes (1)

  • Modified Ashworth Scale (MAS), Modified Tardieu Scale (MTS)

    patients will be evaluated within 1 month after basic history taking and consent signing

Secondary Outcomes (6)

  • the thickness of biceps brachii

    patients will be evaluated within 1 month after basic history taking and signing consent

  • Heckmatt scale

    patients will be evaluated within 1 month after finishing history taking and consent signing

  • strain ratio

    patients will be evaluated within 1 month after finishing history taking and consent signing

  • Dynamic Sonoelastography Score(DS score)

    patients will be evaluated within 1 month after finishing history taking and consent signing

  • The mean values of the intensity of red, green, and blue on histogram of bicep brachii

    patients will be evaluated within 1 month after finishing history taking and consent signing

  • +1 more secondary outcomes

Interventions

Two physiatrists will perform ultrasound elastography and ARFI for intra-rater and inter-rater reliability evaluation.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

refer from physiatrists in Kaohsiung Chang Gung Memorial Hospital

You may qualify if:

  • stroke patients with hemiplegia and biceps brachii muscle spasticity.

You may not qualify if:

  • elbow joint contracture deformity
  • combined other neuromuscular system disease
  • affected upper extremity has local infection
  • patient who can't follow instruction, who is restlessness and whose elbow can't meet the positioning criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

Location

Related Publications (29)

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    PMID: 19117179BACKGROUND
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    PMID: 16965971BACKGROUND
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    PMID: 22502807BACKGROUND
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    PMID: 23771348BACKGROUND
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MeSH Terms

Conditions

StrokeMuscle Spasticity

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Pong Ya-Ping, MD

    Rehabilitation

    STUDY CHAIR

Central Study Contacts

Pong Ya-Ping, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2015

First Posted

September 23, 2015

Study Start

June 1, 2016

Primary Completion

May 1, 2017

Study Completion

September 1, 2017

Last Updated

March 30, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations