H-reflex Measurement in Hemiplegic Stroke Patients

NCT04977531 | Unknown

• 1 other identifier: (868)110-14
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Stroke; Hemiplegia; Spasticity as Sequela of Stroke

Keywords

H/M slope; H/M maximal amplitude; H/M threshold; stroke; spasticity

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• H/M slope and modified Ashworth Scale(MAS)

  30 minutes

Study Arms (3)

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

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Inpatient or outpatient at department of physical medicine and rehabilitation

You may qualify if:

• Single episode of stroke
• Single side hemiplegia after stroke

You may not qualify if:

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

Sponsors & Collaborators

• Heng-Yi, Shen: lead

Related Publications (11)

• 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.

  PMID: 27794138 BACKGROUND

• 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.

  PMID: 25027141 BACKGROUND

• Bejot 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.

  PMID: 27816343 BACKGROUND

• 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. doi: 10.1053/apmr.2002.35473.

  PMID: 12422337 BACKGROUND

• 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.

  PMID: 25171879 BACKGROUND

• 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.

  PMID: 18377996 BACKGROUND

• Aloraini 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.

  PMID: 25690684 BACKGROUND

• 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;203(2):127-30. doi: 10.1016/0304-3940(95)12284-2.

  PMID: 8834110 RESULT

• Walton C, Kalmar J, Cafarelli E. Caffeine increases spinal excitability in humans. Muscle Nerve. 2003 Sep;28(3):359-64. doi: 10.1002/mus.10457.

  PMID: 12929197 RESULT

• 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.

  PMID: 22277759 RESULT

• 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. doi: 10.1053/apmr.2001.25081.

  PMID: 11689982 RESULT

MeSH Terms

Conditions

Stroke; Hemiplegia; Muscle Spasticity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations

Study Officials

• Szu-fu Chen, MD, PHD

  Cheng-Hsin General Hospital

  STUDY DIRECTOR

Central Study Contacts

Heng-Yi Shen, MD

CONTACT

+886911733228; leon15987@gmail.com

Szu-fu Chen, MD, PHD

CONTACT

+886-2-28264400; szufuchen@yahoo.com.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident of Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: July 10, 2021
• First Posted: July 27, 2021
• Study Start: August 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: July 27, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share