H-reflex Measurement in Hemiplegic Stroke Patients

July 15, 2021 updated by: Heng-Yi, Shen
As human beings live longer, geriatric disease develop, one of which was stroke whose prevalence elevated by aging. Increased spasticity is a common symptom after stroke and may hinder patient from rehabilitation. The spasticity was evaluated by subjective judgement before. However, in the recent studies, the electrophysiological test, an objective evaluation, showed possibly positive correlation with the spasticity. They compared stroke patients' hemiplegic side with non-hemiplegic side by H/M ratio which showed significant difference. The stroke patients included in studies had stroke onset over 2 years. Therefore, investigators wonder if H/M ratio can evaluate spasticity in stroke patients onset within 2 years and if H/M ratio is correlated to spasticity.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Stroke is a condition that insufficient brain blood supply due to ischemia or hemorrhage causes brain cell death, which impacts normal function of motor, sensory, and speech, depending on the damaged location. Over the world wide, the incidence of stroke is 119 per 100,000 population per year with death rate up to 10-42% in one month after stroke. The survivor developed varying degrees of spasticity up to 42.6%.

In the conventional physical examination, modified Ashworth scale is used to evaluate spasticity, but its results may be influenced by temperature, joints range of motion, subjective judgement by tester or patient's nervousness. In the previous studies, spasticity between hemiplegic side and sound side showed significant difference in ratio of H/M amplitude, H/M threshold and H/M slope. Among them, H/M slope is the most sensitive tool and may be correlated to increased spasticity because H/M slope showed higher value in people with Brunnstrom stage III.

However, patients included in previous studies had disease onset over 2 years. The gold recovery stage after stroke is within 6 months. During this time, many methods can be used to reduce spasticity, such as medicine, stretching exercise, and injection. Therefore, it is very important whether H/M ratio for spasticity evaluation can be performed in patients with disease onset less than 2 years.

In our study, according to onset time, participants will be assigned to three groups: less than 6 months, 6 months to 2 years, and over 2 years. All the participants will accept electrophysiological test over four limbs to collect data of H/M ratio of slope, maximal amplitude and threshold. Hemiplegic side will be compared with sound side for significant difference. The relation between H/M ratio and modified Ashworth Scale will also be identified.

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

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

Study Contact

Study Contact Backup

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

Ages Eligible for Study

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Inpatient or outpatient at department of physical medicine and rehabilitation

Description

Inclusion Criteria:

  • Single episode of stroke
  • Single side hemiplegia after stroke

Exclusion Criteria:

  • Other diagnosis of neurovascular disease or major cardiovascular disease
  • Poor cognition
  • Poor cooperation
  • Aphasia
  • People who can not tolerate the exam

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

Cohorts and Interventions

Group / Cohort
6 months less
Stroke onset less than 6 months
6 months to 2 years
Stroke onset between 6 months and 2 years
over 2 years
Stroke onset over 2 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nerve conduction study (H/M slope)
Time Frame: 30 minutes
To compare the hemiplegic side and sound side difference, investigators will exam four limbs twice and obtain two data of H and M. Electrodes were placed on each limb and the electrical impulse from low to high ampere will elicit several data of H and M from low to high values. Average of H slope will be calculated and divided by average of M slope, without unit.
30 minutes
Nerve conduction study (H/M maximal amplitude)
Time Frame: 30 minutes
To compare the hemiplegic side and sound side difference, investigators will exam four limbs twice and obtain two data of H and M. Electrodes were placed on each limb and the electrical impulse from low to high ampere will elicit several data of H and M from low to high values. Maximal H value will be divided by maximal M value, without unit.
30 minutes
Nerve conduction study (H/M threshold)
Time Frame: 30 minutes
To compare the hemiplegic side and sound side difference, investigators will exam four limbs twice and obtain two data of H and M. Electrodes were placed on each limb and the electrical impulse from low to high ampere will elicit several data of H and M from low to high values. The ampere which elicited first data of H or M will be the threshold. The threshold of H will be divided by the threshold of M, without unit.
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
H/M slope and modified Ashworth Scale(MAS)
Time Frame: 30 minutes
Investigators will evaluate if increasing H/M slope is positively correlated with increasing modified Ashworth Scale(MAS). The MAS is used to measure muscle tone, with score of 0, 1, 1+, 2, 3, 4. The higher score means the higher muscle tone.
30 minutes

Collaborators and Investigators

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

Sponsor

Heng-Yi, Shen

Investigators

  • Study Director: Szu-fu Chen, MD, PHD, Cheng-Hsin general hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ANTICIPATED)

August 1, 2021

Primary Completion (ANTICIPATED)

December 31, 2022

Study Completion (ANTICIPATED)

December 31, 2022

Study Registration Dates

First Submitted

July 10, 2021

First Submitted That Met QC Criteria

July 15, 2021

First Posted (ACTUAL)

July 27, 2021

Study Record Updates

Last Update Posted (ACTUAL)

July 27, 2021

Last Update Submitted That Met QC Criteria

July 15, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • (868)110-14

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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