Post-stroke Upper Limb SpasticityNCT05940805
Comprehensive Protocol for Treatment of Upper Limb Spasticity in Post-stroke Hemiplegic Patients
A study testing Low-frequency transcranial electrical stimulation; Paraspinous block; Dry needling of spastic upper limb muscles; Muscular functional electrical stimulation (FES) in people with Post-stroke Upper Limb Spasticity, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The general objective of this study was to evaluate the efficacy of the comprehensive protocol in improving post-stroke upper limb spasticity. The specific objectives were to evaluate pain improvement and changes in quality of life and functional capacity in patients who were subjected to the comprehensive protocol… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-stroke Upper Limb Spasticity
- What is being tested?
- Low-frequency transcranial electrical stimulation; Paraspinous block; Dry needling of spastic upper limb muscles; Muscular functional electrical stimulation (FES)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteBrazil
- Study dates
- 3 Aug 2023to 3 Dec 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age older than 18 years;
- Diagnosis of ischemic or hemorrhagic stroke at least six months previously;
- Presence of single upper limb spasticity
Who cannot join
- Spasticity due to conditions other than stroke;
- Hypersensitivity to lidocaine;
- Use of cardiac pacemakers;
- Presence of coagulation disturbances;
- Insufficient perceptual and cognitive capacity to understand the proposed treatment and answer the questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial to Evaluate a Comprehensive Protocol With Four Therapeutic Modalities for the Treatment of Upper Limb Spasticity in Post-stroke Hemiplegic Patients
The general objective of this study was to evaluate the efficacy of the comprehensive protocol in improving post-stroke upper limb spasticity. The specific objectives were to evaluate pain improvement and changes in quality of life and functional capacity in patients who were subjected to the comprehensive protocol compared with those in the patients who underwent sham interventions.
Read the detailed description
Background: Managing post-stroke upper limb spasticity is a major challenge in the rehabilitation field. The objective of this study was to evaluate the efficacy of a comprehensive treatment protocol with four therapeutic modalities in the recovery of patients with chronic stroke by evaluating clinical, neurological and functional outcomes.
Methodology: Thirty-two subjects diagnosed with a stroke at least six months prior to the study were randomized to receive ten sessions of either the treatment protocol or a sham intervention. The treatment protocol consisted of transcranial low-frequency electrical stimulation using subcutaneous needles over the scalp, paraspinous blocks, spastic muscle needling and functional electrical stimulation. Spasticity, range of motion, pain, functionality and quality of life were evaluated.
- Conditions
- Post-stroke Upper Limb Spasticity
- Being tested
- Low-frequency transcranial electrical stimulation; Paraspinous block; Dry needling of spastic upper limb muscles; Muscular functional electrical stimulation (FES), SHAM Low-frequency transcranial electrical stimulation; Paraspinous block; Dry needling of spastic upper limb muscles; Muscular functional electrical stimulation (FES)
- Keywords
- Muscle Spasticity, Stroke, Stroke Rehabilitation, Nerve Block, Dry Needling, Transcranial Direct Current Stimulation, Electric Stimulation Therapy
- Medical subject headings
- Muscle Spasticity, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-frequency transcranial electrical stimulation; Paraspinous block; Dry needling of spastic upper limb muscles; Muscular functional electrical stimulation (FES)Procedure or surgery
- Low-frequency transcranial electrical stimulation (2/100 Hz) applied through 0.3-mm-diameter and 40-mm-long needles placed subcutaneously on the scalp at the projection of Penfield's motor homunculus and sensory and frontal supplementary motor associative areas.
- Paraspinous block at the levels of the C5, C6 and C7 vertebrae concordant with spasticity laterality.
- Dry needling of spastic upper limb muscles, as identified through a thorough physical examination, using 0.3-mm-diameter and 40-mm-long needles.
- Muscular functional electrical stimulation (FES) in the antagonists of the upper limb muscles with spasticity with the following parameters: 20-Hz frequency, 300-µs pulse width, zero-second ramp time, 5-second stimulation time, and 5-second resting time.
SHAM Low-frequency transcranial electrical stimulation; Paraspinous block; Dry needling of spastic upper limb muscles; Muscular functional electrical stimulation (FES)Procedure or surgery
For simulation of transcranial electrical stimulation and FES, electrodes were placed on the scalp and in the upper extremity muscles and were connected to a device similar to the real electric current generator. This device did not transmit any electric current but had blinking lights and produced sound to provide the subjects visual and auditory feedback. To simulate dry needling and paraspinous block, retractile needles were used.
| Study group | Role | What they receive |
|---|---|---|
| Protocol Group (PG) | Experimental | The PG received the following combination of four therapeutic modalities twice a week for five weeks:
1. Low-frequency transcranial electrical stimulation;
2. Paraspinous block;
3. Dry needling of spastic upper limb muscles;
4. Muscular functional electrical stimulation (FES). Receives: Procedure: Low-frequency transcranial electrical stimulation; Paraspinous block; Dry needling of spastic upper limb muscles; Muscular functional electrical stimulation (FES) |
| Sham Group (SG) | Sham comparator | The Sham Group also received the four modalities of the intervention, but these modalities were all inactive. For simulation of transcranial electrical stimulation and FES, electrodes were placed on the scalp and in the upper extremity muscles and were connected to a device similar to the real electric current generator. This device did not transmit any electric current but had blinking lights and produced sound to provide the subjects visual and auditory feedback. To simulate dry needling and paraspinous block, retractile needles were used. The patients were blinded to their assigned treatment group. Receives: Procedure: SHAM Low-frequency transcranial electrical stimulation; Paraspinous block; Dry needling of spastic upper limb muscles; Muscular functional electrical stimulation (FES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Ashworth scale
To measure spasticity, and shoulder, elbow and wrist active and passive goniometry was performed to measure range of motion improvement. Minimum value = 0 (No increase in tone); Maximum value = 4 (Affected part in rigid flexion and extension)
Measured: 3 months
Visual analogue scale (VAS)
To measure patients pain after the interventions. Minimun value = 0 (Painless); Maximum value = 10 (painful)
Measured: 3 months
Functional independence measure (FIM)
To measure independence of patients after the interventions. The Functional Independence Measure (FIM) is a functional assessment with 18 items in the areas of personal care, sphincter control, mobility, communication and social-cognition, through a broad questionnaire. Minimun value = 18 (total dependence); maximum value = 126 (total independence)
Measured: 3 months
Quality of Life - SF-36 questionnaire
To measure patients' quality of life after the interventions for each domain. Minimum value (for each domain) = 0 (bad quality of life); Maximum value for each domain = 100 (good quality of life)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start3 Aug 2023
- Primary completion12 Nov 2023
- Study completion3 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Post-stroke Upper Limb SpasticityStudies 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
- Thirty-two subjects diagnosed with a stroke at least six months prior to the study were randomized to receive ten sessions of either the treatment protocol or a sham intervention. The treatment protocol consisted of transcranial low-frequency electrical stimulation using subcutaneous needles over the scalp, paraspinous blocks, spastic muscle needling and functional electrical stimulation. Spasticity, range of motion, pain, functionality and quality of life were evaluated.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wu Tu Hsing, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05940805
- Sponsor's protocol ID
- 3853051109
- Status last verified
- Jul 2024
- First submitted
- 6 Jun 2023
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Treger I, Shames J, Giaquinto S, Ring H. Return to work in stroke patients. Disabil Rehabil. 2007 Sep 15;29(17):1397-403. doi: 10.1080/09638280701314923.
PubMed 17729085Ovbiagele B, Nguyen-Huynh MN. Stroke epidemiology: advancing our understanding of disease mechanism and therapy. Neurotherapeutics. 2011 Jul;8(3):319-29. doi: 10.1007/s13311-011-0053-1.
PubMed 21691873Roger VL, Go AS, Lloyd-Jones DM, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Soliman EZ, Sorlie PD, Sotoodehnia N, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Executive summary: heart disease and stroke statistics--2012 update: a report from the American Heart Association. Circulation. 2012 Jan 3;125(1):188-97. doi: 10.1161/CIR.0b013e3182456d46. No abstract available.
PubMed 22215894Ones K, Yilmaz E, Cetinkaya B, Caglar N. Quality of life for patients poststroke and the factors affecting it. J Stroke Cerebrovasc Dis. 2005 Nov-Dec;14(6):261-6. doi: 10.1016/j.jstrokecerebrovasdis.2005.07.003.
PubMed 17904035Burke D, Wissel J, Donnan GA. Pathophysiology of spasticity in stroke. Neurology. 2013 Jan 15;80(3 Suppl 2):S20-6. doi: 10.1212/WNL.0b013e31827624a7.
PubMed 23319482Sunnerhagen KS, Olver J, Francisco GE. Assessing and treating functional impairment in poststroke spasticity. Neurology. 2013 Jan 15;80(3 Suppl 2):S35-44. doi: 10.1212/WNL.0b013e3182764aa2.
PubMed 23319484Schlaug G, Renga V, Nair D. Transcranial direct current stimulation in stroke recovery. Arch Neurol. 2008 Dec;65(12):1571-6. doi: 10.1001/archneur.65.12.1571.
PubMed 19064743Bhakta BB. Management of spasticity in stroke. Br Med Bull. 2000;56(2):476-85. doi: 10.1258/0007142001903111.
PubMed 11092096Gerwin RD. Myofascial pain and fibromyalgia: Diagnosis and treatment. J Back Musculoskelet Rehabil. 1998 Jan 1;11(3):175-81. doi: 10.3233/BMR-1998-11304.
PubMed 24572598Teasell RW, Foley NC, Bhogal SK, Speechley MR. An evidence-based review of stroke rehabilitation. Top Stroke Rehabil. 2003 Spring;10(1):29-58. doi: 10.1310/8YNA-1YHK-YMHB-XTE1.
PubMed 12970830Raju RS, Sarma PS, Pandian JD. Psychosocial problems, quality of life, and functional independence among Indian stroke survivors. Stroke. 2010 Dec;41(12):2932-7. doi: 10.1161/STROKEAHA.110.596817. Epub 2010 Oct 21.
PubMed 20966411Boyaci A, Topuz O, Alkan H, Ozgen M, Sarsan A, Yildiz N, Ardic F. Comparison of the effectiveness of active and passive neuromuscular electrical stimulation of hemiplegic upper extremities: a randomized, controlled trial. Int J Rehabil Res. 2013 Dec;36(4):315-22. doi: 10.1097/MRR.0b013e328360e541.
PubMed 23579106de Kroon JR, IJzerman MJ. Electrical stimulation of the upper extremity in stroke: cyclic versus EMG-triggered stimulation. Clin Rehabil. 2008 Aug;22(8):690-7. doi: 10.1177/0269215508088984.
PubMed 18678569Hara Y, Ogawa S, Muraoka Y. Hybrid power-assisted functional electrical stimulation to improve hemiparetic upper-extremity function. Am J Phys Med Rehabil. 2006 Dec;85(12):977-85. doi: 10.1097/01.phm.0000247853.61055.f8.
PubMed 17117002Wu D, Qian L, Zorowitz RD, Zhang L, Qu Y, Yuan Y. Effects on decreasing upper-limb poststroke muscle tone using transcranial direct current stimulation: a randomized sham-controlled study. Arch Phys Med Rehabil. 2013 Jan;94(1):1-8. doi: 10.1016/j.apmr.2012.07.022. Epub 2012 Aug 7.
PubMed 22878231
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Evaluate a Comprehensive Protocol With Four Therapeutic Modalities for the Treatment of Upper Limb Spasticity in Post-stroke Hemiplegic Patients
- ClinicalTrials.gov ID
- NCT05940805
- Acronym / sponsor ID
- 3853051109
- Conditions
- Post-stroke Upper Limb Spasticity
- Keywords
- Muscle Spasticity, Stroke, Stroke Rehabilitation, Nerve Block, Dry Needling, Transcranial Direct Current Stimulation, Electric Stimulation Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 3 Aug 2023 (actual)
- Primary completion
- 12 Nov 2023 (actual)
- Study completion
- 3 Dec 2023 (actual)
- First posted
- 11 Jul 2023 (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.
The general objective of this study was to evaluate the efficacy of the comprehensive protocol in improving post-stroke upper limb spasticity. The specific objectives were to evaluate pain improvement and changes in quality of life and functional capacity in patients who were subjected to the comprehensive protocol compared with those in the patients who underwent sham interventions.
Detailed description
Background: Managing post-stroke upper limb spasticity is a major challenge in the rehabilitation field. The objective of this study was to evaluate the efficacy of a comprehensive treatment protocol with four therapeutic modalities in the recovery of patients with chronic stroke by evaluating clinical, neurological and functional outcomes.
Methodology: Thirty-two subjects diagnosed with a stroke at least six months prior to the study were randomized to receive ten sessions of either the treatment protocol or a sham intervention. The treatment protocol consisted of transcranial low-frequency electrical stimulation using subcutaneous needles over the scalp, paraspinous blocks, spastic muscle needling and functional electrical stimulation. Spasticity, range of motion, pain, functionality and quality of life were evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Thirty-two subjects diagnosed with a stroke at least six months prior to the study were randomized to receive ten sessions of either the treatment protocol or a sham intervention. The treatment protocol consisted of transcranial low-frequency electrical stimulation using subcutaneous needles over the scalp, paraspinous blocks, spastic muscle needling and functional electrical stimulation. Spasticity, range of motion, pain, functionality and quality of life were evaluated.
| Arm | Type | Receives |
|---|---|---|
| Protocol Group (PG) | Experimental | Procedure: Low-frequency transcranial electrical stimulation; Paraspinous block; Dry needling of spastic upper limb muscles; Muscular functional electrical stimulation (FES)The PG received the following combination of four therapeutic modalities twice a week for five weeks: 1. Low-frequency transcranial electrical stimulation; 2. Paraspinous block; 3. Dry needling of spastic upper limb muscles; 4. Muscular functional electrical stimulation (FES). |
| Sham Group (SG) | Sham comparator | Procedure: SHAM Low-frequency transcranial electrical stimulation; Paraspinous block; Dry needling of spastic upper limb muscles; Muscular functional electrical stimulation (FES)The Sham Group also received the four modalities of the intervention, but these modalities were all inactive. For simulation of transcranial electrical stimulation and FES, electrodes were placed on the scalp and in the upper extremity muscles and were connected to a device similar to the real electric current generator. This device did not transmit any electric current but had blinking lights and produced sound to provide the subjects visual and auditory feedback. To simulate dry needling and paraspinous block, retractile needles were used. The patients were blinded to their assigned treatment group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age older than 18 years;
- Diagnosis of ischemic or hemorrhagic stroke at least six months previously;
- Presence of single upper limb spasticity
Key exclusion criteria (5 listed)
- Spasticity due to conditions other than stroke;
- Hypersensitivity to lidocaine;
- Use of cardiac pacemakers;
- Presence of coagulation disturbances;
- Insufficient perceptual and cognitive capacity to understand the proposed treatment and answer the questionnaires
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 |
|---|---|---|
| Low-frequency transcranial electrical stimulation; Paraspinous block; Dry needling of spastic upper limb muscles; Muscular functional electrical stimulation (FES)1. Low-frequency transcranial electrical stimulation (2/100 Hz) applied through 0.3-mm-diameter and 40-mm-long needles placed subcutaneously on the scalp at the projection of Penfield's motor homunculus and sensory and frontal supplementary motor associative areas. 2. Paraspinous block at the levels of the C5, C6 and C7 vertebrae concordant with spasticity laterality. 3. Dry needling of spastic upper limb muscles, as identified through a thorough physical examination, using 0.3-mm-diameter and 40-mm-long needles. 4. Muscular functional electrical stimulation (FES) in the antagonists of the upper limb muscles with spasticity with the following parameters: 20-Hz frequency, 300-µs pulse width, zero-second ramp time, 5-second stimulation time, and 5-second resting time. | Procedure or surgery | Protocol Group (PG) |
| SHAM Low-frequency transcranial electrical stimulation; Paraspinous block; Dry needling of spastic upper limb muscles; Muscular functional electrical stimulation (FES)For simulation of transcranial electrical stimulation and FES, electrodes were placed on the scalp and in the upper extremity muscles and were connected to a device similar to the real electric current generator. This device did not transmit any electric current but had blinking lights and produced sound to provide the subjects visual and auditory feedback. To simulate dry needling and paraspinous block, retractile needles were used. | Procedure or surgery | Sham Group (SG) |
Primary outcome
Modified Ashworth scale
Time frame: 3 months
To measure spasticity, and shoulder, elbow and wrist active and passive goniometry was performed to measure range of motion improvement. Minimum value = 0 (No increase in tone); Maximum value = 4 (Affected part in rigid flexion and extension)
Visual analogue scale (VAS)
Time frame: 3 months
To measure patients pain after the interventions. Minimun value = 0 (Painless); Maximum value = 10 (painful)
Functional independence measure (FIM)
Time frame: 3 months
To measure independence of patients after the interventions. The Functional Independence Measure (FIM) is a functional assessment with 18 items in the areas of personal care, sphincter control, mobility, communication and social-cognition, through a broad questionnaire. Minimun value = 18 (total dependence); maximum value = 126 (total independence)
Quality of Life - SF-36 questionnaire
Time frame: 3 months
To measure patients' quality of life after the interventions for each domain. Minimum value (for each domain) = 0 (bad quality of life); Maximum value for each domain = 100 (good quality of life)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Background: PubMed 17729085Treger I, Shames J, Giaquinto S, Ring H. Return to work in stroke patients. Disabil Rehabil. 2007 Sep 15;29(17):1397-403. doi: 10.1080/09638280701314923.
- Background: PubMed 21691873Ovbiagele B, Nguyen-Huynh MN. Stroke epidemiology: advancing our understanding of disease mechanism and therapy. Neurotherapeutics. 2011 Jul;8(3):319-29. doi: 10.1007/s13311-011-0053-1.
- Background: PubMed 22215894Roger VL, Go AS, Lloyd-Jones DM, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Soliman EZ, Sorlie PD, Sotoodehnia N, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Executive summary: heart disease and stroke statistics--2012 update: a report from the American Heart Association. Circulation. 2012 Jan 3;125(1):188-97. doi: 10.1161/CIR.0b013e3182456d46. No abstract available.
- Background: PubMed 17904035Ones K, Yilmaz E, Cetinkaya B, Caglar N. Quality of life for patients poststroke and the factors affecting it. J Stroke Cerebrovasc Dis. 2005 Nov-Dec;14(6):261-6. doi: 10.1016/j.jstrokecerebrovasdis.2005.07.003.
- Background: PubMed 23319482Burke D, Wissel J, Donnan GA. Pathophysiology of spasticity in stroke. Neurology. 2013 Jan 15;80(3 Suppl 2):S20-6. doi: 10.1212/WNL.0b013e31827624a7.
- Background: PubMed 23319484Sunnerhagen KS, Olver J, Francisco GE. Assessing and treating functional impairment in poststroke spasticity. Neurology. 2013 Jan 15;80(3 Suppl 2):S35-44. doi: 10.1212/WNL.0b013e3182764aa2.
- Background: PubMed 19064743Schlaug G, Renga V, Nair D. Transcranial direct current stimulation in stroke recovery. Arch Neurol. 2008 Dec;65(12):1571-6. doi: 10.1001/archneur.65.12.1571.
- Background: PubMed 11092096Bhakta BB. Management of spasticity in stroke. Br Med Bull. 2000;56(2):476-85. doi: 10.1258/0007142001903111.
- Background: PubMed 24572598Gerwin RD. Myofascial pain and fibromyalgia: Diagnosis and treatment. J Back Musculoskelet Rehabil. 1998 Jan 1;11(3):175-81. doi: 10.3233/BMR-1998-11304.
- Background: PubMed 12970830Teasell RW, Foley NC, Bhogal SK, Speechley MR. An evidence-based review of stroke rehabilitation. Top Stroke Rehabil. 2003 Spring;10(1):29-58. doi: 10.1310/8YNA-1YHK-YMHB-XTE1.
- Background: PubMed 20966411Raju RS, Sarma PS, Pandian JD. Psychosocial problems, quality of life, and functional independence among Indian stroke survivors. Stroke. 2010 Dec;41(12):2932-7. doi: 10.1161/STROKEAHA.110.596817. Epub 2010 Oct 21.
- Background: PubMed 23579106Boyaci A, Topuz O, Alkan H, Ozgen M, Sarsan A, Yildiz N, Ardic F. Comparison of the effectiveness of active and passive neuromuscular electrical stimulation of hemiplegic upper extremities: a randomized, controlled trial. Int J Rehabil Res. 2013 Dec;36(4):315-22. doi: 10.1097/MRR.0b013e328360e541.
- Projeto Diretrizes da Associação Médica Brasileira e Conselho Federal de Medicina - Diagnóstico e Tratamento da Espasticidade. 2001.Link provided by the sponsor.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-frequency transcranial electrical stimulation; Paraspinous block; Dry needling of spastic upper limb muscles; Muscular functional electrical stimulation (FES) in people with Post-stroke Upper Limb Spasticity, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 3 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: finished, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Modified Ashworth scale (time frame: 3 months). The study lists 4 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 NCT05940805, which also lists 24 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 25 Jul 2024.