H-reflex Measurement in Hemiplegic Stroke Patients

Stroke Clinical Trial

Official title:

H-reflex Measurement in Hemiplegic Stroke Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04977531
• Other study ID #: (868)110-14
• Status: Not yet recruiting
• Start date: August 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2021
• Source: Cheng-Hsin General Hospital
• Contact: Heng-Yi Shen, MD
• Phone: +886911733228
• Email: leon15987[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemiplegia
• Muscle Spasticity
• Spasticity as Sequela of Stroke
• Stroke

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Heng-Yi, Shen

References & Publications (11)

Aloraini SM, Gäverth 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. Review. — View Citation

Béjot 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. — View Citation

Funase 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 — View Citation

Hendricks 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. Review. — View Citation

Higashi 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. — View Citation

Koton 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. — View Citation

Phadke 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. — View Citation

Stowe 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. — View Citation

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. Review. — View Citation

Walton C, Kalmar J, Cafarelli E. Caffeine increases spinal excitability in humans. Muscle Nerve. 2003 Sep;28(3):359-64. — View Citation

Wissel 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. Review. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 minutes
Primary	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.	30 minutes
Primary	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.	30 minutes
Secondary	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.	30 minutes