HemiplegiaNCT03811106
Neuromuscular Electrical Stimulation (NMES) in Stroke-diagnosed Individuals
A study testing NeuromuscularElectricalStimulation+ConventionalPhysiotherapy and Conventional physiotherapy and rehabilitation in people with Hemiplegia, run by Firat University.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Hemiplegia
- What is being tested?
- NeuromuscularElectricalStimulation+ConventionalPhysiotherapy and Conventional physiotherapy and rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- 4 Mar 2019to 4 Nov 2019
- Phase
- Interventional
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Neuromuscular Electrical Stimulation (NMES) Applied to Back Extensors in Stroke Patients; Effects on Functional Capacity and Mobility
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.
Read more
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.
Read the detailed description
Our study will be carried out in Fırat University Training and Research Hospital. Individuals who are diagnosed with stroke by the Physical Medicine and Rehabilitation Specialist and who are directed to the physiotherapy program will be included. 20 hemiparesis patients who underwent stimulation and conventional physiotherapy and rehabilitation of the back extensors, will constitute 20 volunteer patients who only provided conventional physiotherapy and rehabilitation applications. 20 cases were included in the study and 20 cases as control group. All cases will be informed and approved before they start working.
Inclusion Criteria
- 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
Criteria for Inclusion of Patients in the Study
- 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
As demographic characteristics; age, gender, body weight, height of the patients, the hand (dominant hemisphere), occupation and educational status, as a history of the disease; It will be noted whether the patient has undergone SVO or transient ischemic attack. Our neurological evaluation form; Reflexes, sensory defects, cranial nerve lesion, visual disturbances, speech problem and type will be recorded.
All patients will be evaluated after treatment (TS). Spasticity will be graded from 0 to 5 according to the Modified Ashworth Scale.
Postural Assesment of Stroke Scale (PASS), Short Form-36, Adapted Patient Evaluation and Conference System, Stroke Rehabilitation Assesment of Movement (STREAM), Brunel Balance Assessment (BBA), Functional Ambulation Scale(FAS) and Mini-Mental State Examination (MMSE) surveys and scales will be used.
Stimulation program, symmetrical biphasic waveform, 50 Hz frequency, 400 μs width flow characteristics are used and the duration of treatment should be 30 min.
The current density will be adjusted to give full contraction of the back extensor muscle at each warning. It will be adjusted separately in each session without any discomfort or pain. In cases where contraction is reduced, the intensity of the current will be increased to achieve the same quality contraction. However, the target muscles outside the muscles will spread to the muscles strong enough to be created.
Statistical analysis of the study will be done with Statistical Package for Social Sciences (SPSS) Version IBM Statistic 20. Mann Whitney U test will be used for the differences between the two groups. Comparisons between the pre-treatment and post-treatment values of the patients will be done by Wilcoxon Signed Rank test in dependent groups.
The obtained values will be expressed as mean ± standard deviation (SD). The differences below p <0.05 would be considered significant.
- Conditions
- Hemiplegia
- Being tested
- NeuromuscularElectricalStimulation+ConventionalPhysiotherapy, Conventional physiotherapy and rehabilitation
- Keywords
- Electrotherapy, Neuromuscular Electrical Stimulation, Stroke
- Medical subject headings
- Hemiplegia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuromuscularElectricalStimulation+ConventionalPhysiotherapyDevice
Sırt ekstansör kaslarına nöromusküler elektrik stimülasyonu uygulanacaktır
Conventional physiotherapy and rehabilitationOther
Konvansiyonel fizyoterapi ve rehabilitasyon uygulamaları yapılacaktır.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: NeuromuscularElectricalStimulation+ConventionalPhysiotherapy |
| PT | Other | Conventional physiotherapy and rehabilitation practices will be carried out. Receives: Other: Conventional physiotherapy and rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects on Functional Capacity and Mobility
Survey reviews
Measured: 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
Measured: 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
Measured: 8 Months
Functional Ambulation Classification
Ambulation categories will be determined according to the Functional Ambulation Classification (FAS) developed by Massachusetts General Hospital
Measured: 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).
Measured: 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
Measured: 8 Months
Short Form-36
Quality of life is evaluated by the Short Form-36 health screening form.
Measured: 8 Months
Mini Mental State Examination Test
Cognitive functions will be evaluated on a total of 30 points
Measured: 8 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study start4 Mar 2019 (estimated)
- Primary completion3 Jul 2019 (estimated)
- Study completion4 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for HemiplegiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Furkan BİLEK, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03811106
- Sponsor's protocol ID
- Firat University
- Status last verified
- Feb 2019
- First submitted
- 15 Jan 2019
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16399522De 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.
PubMed 17903951Esquenazi 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.
PubMed 19942187Hummelsheim 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.
PubMed 8330831Linn 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.
PubMed 10229728Karthikbabu 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.
PubMed 21504955Dragin 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.
PubMed 23820295Verheyden 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.
PubMed 17613559Saeys 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.
PubMed 21844283Verheyden 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.
PubMed 18955513Tyson 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.
PubMed 15573837Daley 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.
PubMed 9920188Huang 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.
PubMed 26667386English 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.
PubMed 21584485de 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.
PubMed 19235121
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Electrical Stimulation (NMES) Applied to Back Extensors in Stroke Patients; Effects on Functional Capacity and Mobility
- ClinicalTrials.gov ID
- NCT03811106
- Acronym / sponsor ID
- Firat University
- Conditions
- Hemiplegia
- Keywords
- Electrotherapy, Neuromuscular Electrical Stimulation, Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Study start
- 4 Mar 2019 (estimated)
- Primary completion
- 3 Jul 2019 (estimated)
- Study completion
- 4 Nov 2019 (estimated)
- First posted
- 22 Jan 2019 (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.
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.
Detailed description
Our study will be carried out in Fırat University Training and Research Hospital. Individuals who are diagnosed with stroke by the Physical Medicine and Rehabilitation Specialist and who are directed to the physiotherapy program will be included. 20 hemiparesis patients who underwent stimulation and conventional physiotherapy and rehabilitation of the back extensors, will constitute 20 volunteer patients who only provided conventional physiotherapy and rehabilitation applications. 20 cases were included in the study and 20 cases as control group. All cases will be informed and approved before they start working.
Inclusion Criteria
- 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
Criteria for Inclusion of Patients in the Study
- 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
As demographic characteristics; age, gender, body weight, height of the patients, the hand (dominant hemisphere), occupation and educational status, as a history of the disease; It will be noted whether the patient has undergone SVO or transient ischemic attack. Our neurological evaluation form; Reflexes, sensory defects, cranial nerve lesion, visual disturbances, speech problem and type will be recorded.
All patients will be evaluated after treatment (TS). Spasticity will be graded from 0 to 5 according to the Modified Ashworth Scale.
Postural Assesment of Stroke Scale (PASS), Short Form-36, Adapted Patient Evaluation and Conference System, Stroke Rehabilitation Assesment of Movement (STREAM), Brunel Balance Assessment (BBA), Functional Ambulation Scale(FAS) and Mini-Mental State Examination (MMSE) surveys and scales will be used.
Stimulation program, symmetrical biphasic waveform, 50 Hz frequency, 400 μs width flow characteristics are used and the duration of treatment should be 30 min.
The current density will be adjusted to give full contraction of the back extensor muscle at each warning. It will be adjusted separately in each session without any discomfort or pain. In cases where contraction is reduced, the intensity of the current will be increased to achieve the same quality contraction. However, the target muscles outside the muscles will spread to the muscles strong enough to be created.
Statistical analysis of the study will be done with Statistical Package for Social Sciences (SPSS) Version IBM Statistic 20. Mann Whitney U test will be used for the differences between the two groups. Comparisons between the pre-treatment and post-treatment values of the patients will be done by Wilcoxon Signed Rank test in dependent groups.
The obtained values will be expressed as mean ± standard deviation (SD). The differences below p <0.05 would be considered significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Controlled
| Arm | Type | Receives |
|---|---|---|
| NMES + PT | Active comparator | Device: NeuromuscularElectricalStimulation+ConventionalPhysiotherapyNMES will be applied to the back muscles with the chattanooga intelect advanced device. In addition, conventional physiotherapy and rehabilitation applications will be made. |
| PT | Other | Other: Conventional physiotherapy and rehabilitationConventional physiotherapy and rehabilitation practices will be carried out. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeuromuscularElectricalStimulation+ConventionalPhysiotherapySırt ekstansör kaslarına nöromusküler elektrik stimülasyonu uygulanacaktır | Device | NMES + PT |
| Conventional physiotherapy and rehabilitationKonvansiyonel fizyoterapi ve rehabilitasyon uygulamaları yapılacaktır. | Other | PT |
Primary outcome
Effects on Functional Capacity and Mobility
Time frame: 8 Months
Survey reviews
Brunnel Balance Scale:
Time frame: 8 Months
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
Stroke Rehabilitation Assesment of Movement (STREAM)
Time frame: 8 Months
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
Functional Ambulation Classification
Time frame: 8 Months
Ambulation categories will be determined according to the Functional Ambulation Classification (FAS) developed by Massachusetts General Hospital
Adapted Patient Evaluation and Conference System
Time frame: 8 Months
The balance states of the patients will be evaluated with the evaluation form of Adapted Patient Evaluation and Conference System (APECS).
Postural Assesment of Stroke Scale (PASS)
Time frame: 8 Months
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
Short Form-36
Time frame: 8 Months
Quality of life is evaluated by the Short Form-36 health screening form.
Mini Mental State Examination Test
Time frame: 8 Months
Cognitive functions will be evaluated on a total of 30 points
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- Background: PubMed 16399522Marigold 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.
- Background: PubMed 17903951De 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.
- Background: PubMed 19942187Esquenazi 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.
- Background: PubMed 8330831Hummelsheim 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.
- Background: PubMed 10229728Linn 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.
- Background: PubMed 21504955Karthikbabu 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.
- Background: PubMed 23820295Dragin 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.
- Background: PubMed 17613559Verheyden 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.
- Background: PubMed 21844283Saeys 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.
- Background: PubMed 18955513Verheyden 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.
- Background: PubMed 15573837Tyson 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.
- Background: PubMed 9920188Daley 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.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing NeuromuscularElectricalStimulation+ConventionalPhysiotherapy and Conventional physiotherapy and rehabilitation in people with Hemiplegia, run by Firat University.
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 5 inclusion and 6 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 Feb 2019. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects on Functional Capacity and Mobility (time frame: 8 Months). The study lists 8 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 NCT03811106, which also lists 17 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 Feb 2019.