Neuromuscular Electrical Stimulation (NMES) in Stroke-diagnosed Individuals

NCT03811106 | Unknown

• 1 other identifier: Firat University
• Study Type: interventional
• Target: 2
• Locations: 0 countries
• Sites: N/A

Brief Summary

Specific clinical tools and treatment variables have a key role on the results to be obtained. Therefore, there is a need for well-planned studies on the effect of Neuromuscular Electrical Stimulation (NMES) on stroke patients. Although NMES is frequently used in patients with stroke, scientific evidence regarding back extensor muscle stimulation, functional capacity, balance and mobility efficiency in this patient group is not sufficient. This study was planned to compare controlled individuals with neurological rehabilitation. According to the definition of World Health Organization (WHO) stroke; It is a rapidly developing clinical condition due to local or general impairment of brain functions, without apparent cause other than vascular causes. In the world, the loss of disability and labor force is known as the first and the second cause of deaths. Post-stroke intensive care and rehabilitation processes vary between countries. For example, in Australia, $ 2.14 billion is spent each year for the treatment of stroke-diagnosed individuals, while US $ 65 million is spent annually. For these reasons, it is very important to choose low-cost, effective and evidence-based physiotherapy approaches for people with stroke. Hemiparesis, which is characterized by a loss of power on one side of the body, is the most common neurological loss after stroke. Patients with hemiparetic stroke often have impaired balance, mobility and functional capacity. This results in a high economic burden and social problem in this person. Among the functional problems after stroke; impaired balance, abnormal walking pattern with abnormal asymmetry, abnormal body and spinal movement can be shown. The most important problem is the loss of mobility; bed activities include sitting and standing. The most important goal of stroke rehabilitation is the recovery of mobility and balance. Changes in walking pattern and balance abilities occur due to motor control loss, spasticity, muscle weakness, joint motion deficit, abnormal movement patterns and sensory dysfunction. In addition to neurophysiological treatment techniques such as Bobath, conventional exercise programs, Brunnstrom and proprioceptive neuromuscular parasilication, with the aim of improving the quality of movement and maintaining the balance in rehabilitation of stroke-diagnosed patients, electrical stimulation is also used.Although the importance of back extensor muscle strength is documented in the literature, it is observed that studies focusing on back extensor muscle strength in limb rehabilitation are limited. Control disorders in the posterior extensor muscles after stroke are found to be significantly associated with balance, gait and upper extremity dysfunctions. Based on this idea, our study was planned to examine the effect of NMEs application on functional capacity, balance and mobility in stroke individuals.

Conditions

Hemiplegia

Keywords

Electrotherapy, Neuromuscular Electrical Stimulation, Stroke

Outcome Measures

Primary Outcomes (8)

• Effects on Functional Capacity and Mobility

  Survey reviews

  8 Months

• Brunnel Balance Scale:

  It was developed to evaluate the effectiveness of rehabilitation approaches in stroke patients. Balance performance will be evaluated by 12 tests based on functional performance

  8 Months

• Stroke Rehabilitation Assesment of Movement (STREAM)

  Specially designed by physiotherapists to ensure the quantitative assessment of motor function in patients with stroke. It is easy to perform in the clinic. The most important advantage of this scale is not only the breadth of active movement but also the quality of the movement. Evaluates voluntary movement and basic mobility separately

  8 Months

• Functional Ambulation Classification

  Ambulation categories will be determined according to the Functional Ambulation Classification (FAS) developed by Massachusetts General Hospital

  8 Months

• Adapted Patient Evaluation and Conference System

  The balance states of the patients will be evaluated with the evaluation form of Adapted Patient Evaluation and Conference System (APECS).

  8 Months

• Postural Assesment of Stroke Scale (PASS)

  It is the scale used to evaluate postural control in stroke. It will be used to evaluate the static and dynamic balance of stroke patients

  8 Months

• Short Form-36

  Quality of life is evaluated by the Short Form-36 health screening form.

  8 Months

• Mini Mental State Examination Test

  Cognitive functions will be evaluated on a total of 30 points

  8 Months

Study Arms (2)

NMES + PT

ACTIVE COMPARATOR

NMES will be applied to the back muscles with the chattanooga intelect advanced device. In addition, conventional physiotherapy and rehabilitation applications will be made.

Device: NeuromuscularElectricalStimulation+ConventionalPhysiotherapy

PT

OTHER

Conventional physiotherapy and rehabilitation practices will be carried out.

Other: Conventional physiotherapy and rehabilitation

Interventions

NeuromuscularElectricalStimulation+ConventionalPhysiotherapy DEVICE

Sırt ekstansör kaslarına nöromusküler elektrik stimülasyonu uygulanacaktır

NMES + PT

Conventional physiotherapy and rehabilitation OTHER

Konvansiyonel fizyoterapi ve rehabilitasyon uygulamaları yapılacaktır.

PT

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having a chart of hemiplegia or hemiparesis due to the first story of cerebrovascular accident (SVO)
• At least 3 months after SVO
• Mini-mental State Examination (MMSE) value ≥ 15
• Being in the 30 to 80 age range
• Back extensor muscle spasticity value \<4 according to modified Ashworth Scale

You may not qualify if:

• Ataxia, dystonia, dyskinesia
• The presence of lower motor neuron or peripheral nerve lesion
• Degraded deep senses
• Detection disorder and dementia
• Skin and peripheral circulatory disorder
• History of CVO, bilateral hemiplegia

Sponsors & Collaborators

• Firat University: lead

Related Publications (17)

• Marigold DS, Eng JJ. The relationship of asymmetric weight-bearing with postural sway and visual reliance in stroke. Gait Posture. 2006 Feb;23(2):249-55. doi: 10.1016/j.gaitpost.2005.03.001.

  PMID: 16399522 BACKGROUND

• De Bujanda E, Nadeau S, Bourbonnais D. Pelvic and shoulder movements in the frontal plane during treadmill walking in adults with stroke. J Stroke Cerebrovasc Dis. 2004 Mar-Apr;13(2):58-69. doi: 10.1016/j.jstrokecerebrovasdis.2004.02.006.

  PMID: 17903951 BACKGROUND

• Esquenazi A, Ofluoglu D, Hirai B, Kim S. The effect of an ankle-foot orthosis on temporal spatial parameters and asymmetry of gait in hemiparetic patients. PM R. 2009 Nov;1(11):1014-8. doi: 10.1016/j.pmrj.2009.09.012.

  PMID: 19942187 BACKGROUND

• Hummelsheim H, Mauritz KH. [The neurophysiological basis of exercise physical therapy in patients with central hemiparesis]. Fortschr Neurol Psychiatr. 1993 Jun;61(6):208-16. doi: 10.1055/s-2007-999089. German.

  PMID: 8330831 BACKGROUND

• Linn SL, Granat MH, Lees KR. Prevention of shoulder subluxation after stroke with electrical stimulation. Stroke. 1999 May;30(5):963-8. doi: 10.1161/01.str.30.5.963.

  PMID: 10229728 BACKGROUND

• Karthikbabu S, Nayak A, Vijayakumar K, Misri Z, Suresh B, Ganesan S, Joshua AM. Comparison of physio ball and plinth trunk exercises regimens on trunk control and functional balance in patients with acute stroke: a pilot randomized controlled trial. Clin Rehabil. 2011 Aug;25(8):709-19. doi: 10.1177/0269215510397393. Epub 2011 Apr 19.

  PMID: 21504955 BACKGROUND

• Dragin AS, Konstantinovic LM, Veg A, Schwirtlich LB. Gait training of poststroke patients assisted by the Walkaround (body postural support). Int J Rehabil Res. 2014 Mar;37(1):22-8. doi: 10.1097/MRR.0b013e328363ba30.

  PMID: 23820295 BACKGROUND

• Verheyden G, Nieuwboer A, Van de Winckel A, De Weerdt W. Clinical tools to measure trunk performance after stroke: a systematic review of the literature. Clin Rehabil. 2007 May;21(5):387-94. doi: 10.1177/0269215507074055.

  PMID: 17613559 BACKGROUND

• Saeys W, Vereeck L, Truijen S, Lafosse C, Wuyts FP, Heyning PV. Randomized controlled trial of truncal exercises early after stroke to improve balance and mobility. Neurorehabil Neural Repair. 2012 Mar-Apr;26(3):231-8. doi: 10.1177/1545968311416822. Epub 2011 Aug 15.

  PMID: 21844283 BACKGROUND

• Verheyden G, Vereeck L, Truijen S, Troch M, Lafosse C, Saeys W, Leenaerts E, Palinckx A, De Weerdt W. Additional exercises improve trunk performance after stroke: a pilot randomized controlled trial. Neurorehabil Neural Repair. 2009 Mar-Apr;23(3):281-6. doi: 10.1177/1545968308321776. Epub 2008 Oct 27.

  PMID: 18955513 BACKGROUND

• Tyson SF, DeSouza LH. Development of the Brunel Balance Assessment: a new measure of balance disability post stroke. Clin Rehabil. 2004 Nov;18(7):801-10. doi: 10.1191/0269215504cr744oa.

  PMID: 15573837 BACKGROUND

• Daley K, Mayo N, Wood-Dauphinee S. Reliability of scores on the Stroke Rehabilitation Assessment of Movement (STREAM) measure. Phys Ther. 1999 Jan;79(1):8-19; quiz 20-3.

  PMID: 9920188 BACKGROUND

• Huang YC, Wang WT, Liou TH, Liao CD, Lin LF, Huang SW. Postural Assessment Scale for Stroke Patients Scores as a predictor of stroke patient ambulation at discharge from the rehabilitation ward. J Rehabil Med. 2016 Mar;48(3):259-64. doi: 10.2340/16501977-2046.

  PMID: 26667386 BACKGROUND

• English C, Hillier S. Circuit class therapy for improving mobility after stroke: a systematic review. J Rehabil Med. 2011 Jun;43(7):565-71. doi: 10.2340/16501977-0824.

  PMID: 21584485 RESULT

• de Oliveira CB, de Medeiros IR, Frota NA, Greters ME, Conforto AB. Balance control in hemiparetic stroke patients: main tools for evaluation. J Rehabil Res Dev. 2008;45(8):1215-26.

  PMID: 19235121 RESULT

• Benaim C, Perennou DA, Villy J, Rousseaux M, Pelissier JY. Validation of a standardized assessment of postural control in stroke patients: the Postural Assessment Scale for Stroke Patients (PASS). Stroke. 1999 Sep;30(9):1862-8. doi: 10.1161/01.str.30.9.1862.

  PMID: 10471437 RESULT

• Wade DT. Measurement in neurological rehabilitation. Curr Opin Neurol Neurosurg. 1992 Oct;5(5):682-6.

  PMID: 1392142 RESULT

MeSH Terms

Conditions

Hemiplegia; Stroke

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patient will not know the applications
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Controlled

Study Record Dates

• First Submitted: January 15, 2019
• First Posted: January 22, 2019
• Study Start: March 4, 2019
• Primary Completion: July 3, 2019
• Study Completion: November 4, 2019
• Last Updated: February 27, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share