StrokeNCT04977531
H-reflex Measurement in Hemiplegic Stroke Patients
An observational study of Stroke and Hemiplegia, run by Heng-Yi, Shen.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stroke, Hemiplegia, Spasticity as Sequela of Stroke
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2021to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inpatient or outpatient at department of physical medicine and rehabilitation
Who may be able to join
- Single episode of stroke
- Single side hemiplegia after stroke
Who cannot join
- Other diagnosis of neurovascular disease or major cardiovascular disease
- Poor cognition
- Poor cooperation
- Aphasia
- People who can not tolerate the exam
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Stroke, Hemiplegia, Spasticity as Sequela of Stroke
- Keywords
- H/M slope, H/M maximal amplitude, H/M threshold, stroke, spasticity
- Medical subject headings
- Stroke, Hemiplegia, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Nerve conduction study (H/M slope)
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.
Measured: 30 minutes
Nerve conduction study (H/M maximal amplitude)
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.
Measured: 30 minutes
Nerve conduction study (H/M threshold)
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.
Measured: 30 minutes
Secondary outcomes (1)
H/M slope and modified Ashworth Scale(MAS)
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.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start1 Aug 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heng-Yi, Shen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Heng-Yi, Shen, Cheng-Hsin General Hospital
- Investigators
- Szu-fu Chen, MD, PHD, Study director, Cheng-Hsin General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04977531
- Sponsor's protocol ID
- (868)110-14
- Status last verified
- Jul 2021
- First submitted
- 10 Jul 2021
- Last updated
- 27 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thrift AG, Thayabaranathan T, Howard G, Howard VJ, Rothwell PM, Feigin VL, Norrving B, Donnan GA, Cadilhac DA. Global stroke statistics. Int J Stroke. 2017 Jan;12(1):13-32. doi: 10.1177/1747493016676285. Epub 2016 Oct 28.
PubMed 27794138Koton S, Schneider AL, Rosamond WD, Shahar E, Sang Y, Gottesman RF, Coresh J. Stroke incidence and mortality trends in US communities, 1987 to 2011. JAMA. 2014 Jul 16;312(3):259-68. doi: 10.1001/jama.2014.7692.
PubMed 25027141Bejot Y, Bailly H, Durier J, Giroud M. Epidemiology of stroke in Europe and trends for the 21st century. Presse Med. 2016 Dec;45(12 Pt 2):e391-e398. doi: 10.1016/j.lpm.2016.10.003. Epub 2016 Nov 2.
PubMed 27816343Hendricks HT, van Limbeek J, Geurts AC, Zwarts MJ. Motor recovery after stroke: a systematic review of the literature. Arch Phys Med Rehabil. 2002 Nov;83(11):1629-37. doi: 10.1053/apmr.2002.35473.
PubMed 12422337Wissel J, Verrier M, Simpson DM, Charles D, Guinto P, Papapetropoulos S, Sunnerhagen KS. Post-stroke spasticity: predictors of early development and considerations for therapeutic intervention. PM R. 2015 Jan;7(1):60-7. doi: 10.1016/j.pmrj.2014.08.946. Epub 2014 Aug 27.
PubMed 25171879Stowe AM, Hughes-Zahner L, Stylianou AP, Schindler-Ivens S, Quaney BM. Between-day reliability of upper extremity H-reflexes. J Neurosci Methods. 2008 May 30;170(2):317-23. doi: 10.1016/j.jneumeth.2008.01.031. Epub 2008 Mar 10.
PubMed 18377996Aloraini SM, Gaverth J, Yeung E, MacKay-Lyons M. Assessment of spasticity after stroke using clinical measures: a systematic review. Disabil Rehabil. 2015;37(25):2313-23. doi: 10.3109/09638288.2015.1014933. Epub 2015 Feb 18.
PubMed 25690684Funase K, Higashi T, Yoshimura T, Imanaka K, Nishihira Y. Evident difference in the excitability of the motoneuron pool between normal subjects and patients with spasticity assessed by a new method using H-reflex and M-response. Neurosci Lett. 1996 Jan 19;203(2):127-30. doi: 10.1016/0304-3940(95)12284-2.
PubMed 8834110Walton C, Kalmar J, Cafarelli E. Caffeine increases spinal excitability in humans. Muscle Nerve. 2003 Sep;28(3):359-64. doi: 10.1002/mus.10457.
PubMed 12929197Phadke CP, Robertson CT, Condliffe EG, Patten C. Upper-extremity H-reflex measurement post-stroke: reliability and inter-limb differences. Clin Neurophysiol. 2012 Aug;123(8):1606-15. doi: 10.1016/j.clinph.2011.12.012. Epub 2012 Jan 23.
PubMed 22277759Higashi T, Funase K, Kusano K, Tabira T, Harada N, Sakakibara A, Yoshimura T. Motoneuron pool excitability of hemiplegic patients: assessing recovery stages by using H-reflex and M response. Arch Phys Med Rehabil. 2001 Nov;82(11):1604-10. doi: 10.1053/apmr.2001.25081.
PubMed 11689982
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- H-reflex Measurement in Hemiplegic Stroke Patients
- ClinicalTrials.gov ID
- NCT04977531
- Acronym / sponsor ID
- (868)110-14
- Conditions
- Stroke, Hemiplegia, Spasticity as Sequela of Stroke
- Keywords
- H/M slope, H/M maximal amplitude, H/M threshold, stroke, spasticity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Heng-Yi, ShenUniversity, hospital or other
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 27 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatient or outpatient at department of physical medicine and rehabilitation
Key inclusion criteria (2 listed)
- Single episode of stroke
- Single side hemiplegia after stroke
Key exclusion criteria (5 listed)
- Other diagnosis of neurovascular disease or major cardiovascular disease
- Poor cognition
- Poor cooperation
- Aphasia
- People who can not tolerate the exam
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
1 secondary outcome
H/M slope and modified Ashworth Scale(MAS)
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
- Background: PubMed 27794138Thrift AG, Thayabaranathan T, Howard G, Howard VJ, Rothwell PM, Feigin VL, Norrving B, Donnan GA, Cadilhac DA. Global stroke statistics. Int J Stroke. 2017 Jan;12(1):13-32. doi: 10.1177/1747493016676285. Epub 2016 Oct 28.
- Background: PubMed 25027141Koton S, Schneider AL, Rosamond WD, Shahar E, Sang Y, Gottesman RF, Coresh J. Stroke incidence and mortality trends in US communities, 1987 to 2011. JAMA. 2014 Jul 16;312(3):259-68. doi: 10.1001/jama.2014.7692.
- Background: PubMed 27816343Bejot Y, Bailly H, Durier J, Giroud M. Epidemiology of stroke in Europe and trends for the 21st century. Presse Med. 2016 Dec;45(12 Pt 2):e391-e398. doi: 10.1016/j.lpm.2016.10.003. Epub 2016 Nov 2.
- Background: PubMed 12422337Hendricks HT, van Limbeek J, Geurts AC, Zwarts MJ. Motor recovery after stroke: a systematic review of the literature. Arch Phys Med Rehabil. 2002 Nov;83(11):1629-37. doi: 10.1053/apmr.2002.35473.
- Background: PubMed 25171879Wissel J, Verrier M, Simpson DM, Charles D, Guinto P, Papapetropoulos S, Sunnerhagen KS. Post-stroke spasticity: predictors of early development and considerations for therapeutic intervention. PM R. 2015 Jan;7(1):60-7. doi: 10.1016/j.pmrj.2014.08.946. Epub 2014 Aug 27.
- Background: PubMed 18377996Stowe AM, Hughes-Zahner L, Stylianou AP, Schindler-Ivens S, Quaney BM. Between-day reliability of upper extremity H-reflexes. J Neurosci Methods. 2008 May 30;170(2):317-23. doi: 10.1016/j.jneumeth.2008.01.031. Epub 2008 Mar 10.
- Background: PubMed 25690684Aloraini SM, Gaverth J, Yeung E, MacKay-Lyons M. Assessment of spasticity after stroke using clinical measures: a systematic review. Disabil Rehabil. 2015;37(25):2313-23. doi: 10.3109/09638288.2015.1014933. Epub 2015 Feb 18.
- Results publication: PubMed 8834110Funase K, Higashi T, Yoshimura T, Imanaka K, Nishihira Y. Evident difference in the excitability of the motoneuron pool between normal subjects and patients with spasticity assessed by a new method using H-reflex and M-response. Neurosci Lett. 1996 Jan 19;203(2):127-30. doi: 10.1016/0304-3940(95)12284-2.
- Results publication: PubMed 12929197Walton C, Kalmar J, Cafarelli E. Caffeine increases spinal excitability in humans. Muscle Nerve. 2003 Sep;28(3):359-64. doi: 10.1002/mus.10457.
- Results publication: PubMed 22277759Phadke CP, Robertson CT, Condliffe EG, Patten C. Upper-extremity H-reflex measurement post-stroke: reliability and inter-limb differences. Clin Neurophysiol. 2012 Aug;123(8):1606-15. doi: 10.1016/j.clinph.2011.12.012. Epub 2012 Jan 23.
- Results publication: PubMed 11689982Higashi T, Funase K, Kusano K, Tabira T, Harada N, Sakakibara A, Yoshimura T. Motoneuron pool excitability of hemiplegic patients: assessing recovery stages by using H-reflex and M response. Arch Phys Med Rehabil. 2001 Nov;82(11):1604-10. doi: 10.1053/apmr.2001.25081.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Szu-fu Chen, MD, PHD study director
Cheng-Hsin General Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Hemiplegia, run by Heng-Yi, Shen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heng-Yi Shen, MD (+886911733228, leon15987@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nerve conduction study (H/M slope) (time frame: 30 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04977531, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2021.