StrokePhase 2NCT02690493
The Efficacy of an Acupuncture Protocol and Use of Taping in the Treatment of Spastic Upper Limb After Stroke
A Phase 2 study testing Acupuncture, Functional Taping and Acupuncture and Functional Taping in people with Stroke and Cerebrovascular Stroke, run by Fernanda Cechetti at 1 site in Brazil.
Trial summary
The purpose of this study is to determine whether acupuncture and taping are effective in the treatment of spastic upper limb after stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Cerebrovascular Stroke
- What is being tested?
- Acupuncture, Functional Taping and Acupuncture and Functional Taping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2015to Dec 2015
- Phase
- Phase 2
- 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
- Patients with stroke diagnosis for at least six (06) months, who present hemiparesis in upper limb;
- To accept participate in the study by signing theTerms of Consent;
- Do not have any cognitive impairment.
Who cannot join
- Do not follow the inclusion criteria;
- To present shoulder subluxation or dislocation, shoulder pain syndrome or amputations (with or without the use of aids);
- To present any allergic reaction due to use of bandage and/or do not adapt to treatment with needles.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Health Science of Porto Alegre
Porto Alegre, Rio Grande do Sul, 90050170
About this study
The purpose of this study is to determine whether acupuncture and taping are effective in the treatment of spastic upper limb after stroke.
Read the detailed description
Acupuncture and taping have emerged as treatment alternatives for many diseases with positive and satisfactory results.
Thus, acupuncture seeks to balance all physiological systems, using specific points on the body where needles are inserted.
In turn, the use of taping is associated to various benefits such as improved blood and lymphatic function. In addition, it assists in the correction of muscle function and in the decrease of pain for neurological suppression. The constant afferent mechanical and somatosensory stimuli are perceived in cortical level and may produce motor unit recruitment and contribute to neuroplasticity of the nervous system.
Thus, this research aims to analyze the effects of Acupuncture associated with Functional Taping on patients' upper limb with chronic hemiparesis after Stroke through a prospective, randomized intervention. Seventy-five patients will be evaluated before and after intervention with Acupuncture and / or Function Taping, divided into three groups (Acupuncture, Functional Taping and Acupuncture plus Functional Taping). The evaluation will consist of Isokinetic, Mini-Mental State Examination, Modified Ashworth Scale, Motor Activity Log, Wolf Motor Function Test and Visual Analog Scale of Pain. The results will be analyzed and presented descriptively, as of statistical comparisons of pre- and post-treatment and the relationship between the groups.
- Conditions
- Stroke, Cerebrovascular Stroke
- Being tested
- Acupuncture, Functional Taping, Acupuncture and Functional Taping
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
Acupuncture needles are inserted in specific acupuncture points on the boby (three points on both forearms and five points on the top of the head) for twenty minutes, three times a week, during twelve sessions.
Functional TapingOther
Elastic taping is positioned directly on the skin (on the back of the fingers, hand, forearm and arm - paretic upper limb), three times a week, during twelve sessions. The patient should keep the taping on the skin for two days.
Acupuncture and Functional TapingOther
Acupuncture needles are inserted in specific acupuncture points on the boby (three points on both forearms and five points on the top of the head) for twenty minutes, then elastic taping is positioned directly on skin (on the back of the fingers, hand, forearm and arm - paretic upper limb). Both procedures are performed three times a week, during twelve sessions.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture Only | Active comparator | Patients will be treated with acupuncture only. Receives: Procedure: Acupuncture |
| Functional Taping Only | Active comparator | Patients will be treated with taping only. Receives: Other: Functional Taping |
| Acupuncture and Functional Taping | Experimental | Patients will be treated with both acupuncture and taping at the same session. Receives: Other: Acupuncture and Functional Taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of level of spasticity of upper limb after 12 sessions of intervention, assessed using the Modified Ashworth Scale
Modified Ashworth Scale
Measured: Immediately before the first session of intervention and 2 days after the last (12th) session of intervention.
Secondary outcomes (5)
The change of functionality of upper limb after 12 sessions of intervention, assessed using the Wolf Motor Function Test
Wolf Motor Function Test
Measured: Immediately before the first session of intervention and 2 days after the last (12th) session of intervention.
The change of frequency of movement of upper limb after 12 sessions of intervention
Motor Activity Log
Measured: Immediately before the first session of intervention and 2 days after the last (12th) session of intervention.
The change of quality of movement of upper limb after 12 sessions of intervention
Motor Activity Log
Measured: Immediately before the first session of intervention and 2 days after the last (12th) session of intervention.
The change of amplitude of movement after 12 sessions of intervention, assessed using Manual Goniometer
Manual Goniometry
Measured: Immediately before the first session of intervention and 2 days after the last (12th) session of intervention.
The change of level of pain in upper limb after 12 sessions of intervention, assessed using Visual Analogue Scale
Visual Analogue Scale of Pain
Measured: Immediately before the first session of intervention and 2 days after the last (12th) session of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study startJan 2015
- Primary completionMar 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (56)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fernanda Cechetti
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fernanda Cechetti, Federal University of Health Science of Porto Alegre
- Investigators
- Rodrigo Della Méa Plentz, Doctor, Study director, Federal Universiity of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02690493
- Sponsor's protocol ID
- 935.288
- Status last verified
- Feb 2016
- First submitted
- 14 Feb 2016
- Last updated
- 29 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Andrade FA, Pereira LV, Sousa FA. [Pain measurement in the elderly: a review]. Rev Lat Am Enfermagem. 2006 Mar-Apr;14(2):271-6. doi: 10.1590/s0104-11692006000200018. Epub 2006 May 8. Portuguese.
PubMed 16699703ASSOCIAÇÃO BRASILEIRA DE MEDICINA FÍSICA E REABILITAÇÃO. Espasticidade: Avaliação Clínica. Projeto Diretrizes. 2006.
ASSUMPÇAO, María Sebra de, et al. Coativação, Espasticidade, Desempenho Motor e Funcional na Paralisia Cerebral. Revista Motriz, v. 17, n. 4, out./dez. 2011, p. 650-659.
Belagaje SR, Lindsell C, Moomaw CJ, Alwell K, Flaherty ML, Woo D, Dunning K, Khatri P, Adeoye O, Kleindorfer D, Broderick J, Kissela B. The adverse effect of spasticity on 3-month poststroke outcome using a population-based model. Stroke Res Treat. 2014;2014:696089. doi: 10.1155/2014/696089. Epub 2014 Jul 24.
PubMed 25147752Bodhankar S, Chen Y, Lapato A, Vandenbark AA, Murphy SJ, Offner H. Targeting immune co-stimulatory effects of PD-L1 and PD-L2 might represent an effective therapeutic strategy in stroke. Front Cell Neurosci. 2014 Aug 11;8:228. doi: 10.3389/fncel.2014.00228. eCollection 2014.
PubMed 25157219BRANDÃO, Aline D.; LASKOVSKI, Larissa; GARANHANI, Márcia R. Estratégias de Fisioterapia com Enfoque na Prevenção da Dor no Ombro de Pacientes Hemiplégicos: Revisão Narrativa da Literatura. Fisioterapia em Movimento, v. 21, n. 4, p. 71-78, out./dez. 2008.
BROL, Angela M.; BORTOLOTO, Flavia; MAGAGNIN, Nedi M.S. Tratamento de Restrição e Indução do Movimento na Reabilitação Funcional de Pacientes Pós Acidente Vascular Encefálico: Uma Revisão Bibliográfica. Fisioterapia em Movimento, v. 22, n. 4, p. 497-509, out./dez. 2009.
Cabral DL, Damascena CG, Teixeira-Salmela LF, Laurentino GE. [Reliability of the Nottingham Health Profile after suffering a stroke]. Cien Saude Colet. 2012 May;17(5):1313-22. doi: 10.1590/s1413-81232012000500025. Portuguese.
PubMed 22634824CANCELA, Diana M. G. O Acidente Vascular Cerebral - Classificação, Principais Conseqüências e Reabilitação. Universidade Lusíada do Porto, 2008.
CORREIA, Andreza C. S. et al. Crioterapia e Cinesioterapia no Membro Superior Espástico no Acidente Vascular Cerebral. Fisioterapia em Movimento, v. 23, n. 4, p. 555-563, out./dez. 2010.
DUARTE, Alcino et al., Efeito da Crioterapia na Noção de Posição Articular Activa do Ombro: Um Estudo Comparativo Entre o Género Masculino e Feminino. Revista Portuguesa de Fisioterapia no Desporto, [2007].
Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.
PubMed 1202204Fu TC, Wong AM, Pei YC, Wu KP, Chou SW, Lin YC. Effect of Kinesio taping on muscle strength in athletes-a pilot study. J Sci Med Sport. 2008 Apr;11(2):198-201. doi: 10.1016/j.jsams.2007.02.011. Epub 2007 Jun 27.
PubMed 17588814GOMES, A. C. Acidente Vascular Cerebral Isquêmico Direito e suas Repercussões em Idosos. São Paulo: Pontífica Universidade Católica de São Paulo, 2005.
GOMES, Bruna Moreira et al. O Efeito da Técnica de Reeducação Postural Global de um Paciente com Hemiparesia após Acidente Vascular Encefálico. Revista Acta Fisiátrica, v. 13, n. 2, 2006, p. 103-108.
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of an Acupuncture Protocol and Use of Taping in the Treatment of Spastic Upper Limb After Stroke
- ClinicalTrials.gov ID
- NCT02690493
- Acronym / sponsor ID
- 935.288
- Conditions
- Stroke, Cerebrovascular Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Fernanda CechettiUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Mar 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 24 Feb 2016 (estimated)
- 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 purpose of this study is to determine whether acupuncture and taping are effective in the treatment of spastic upper limb after stroke.
Detailed description
Acupuncture and taping have emerged as treatment alternatives for many diseases with positive and satisfactory results.
Thus, acupuncture seeks to balance all physiological systems, using specific points on the body where needles are inserted.
In turn, the use of taping is associated to various benefits such as improved blood and lymphatic function. In addition, it assists in the correction of muscle function and in the decrease of pain for neurological suppression. The constant afferent mechanical and somatosensory stimuli are perceived in cortical level and may produce motor unit recruitment and contribute to neuroplasticity of the nervous system.
Thus, this research aims to analyze the effects of Acupuncture associated with Functional Taping on patients' upper limb with chronic hemiparesis after Stroke through a prospective, randomized intervention. Seventy-five patients will be evaluated before and after intervention with Acupuncture and / or Function Taping, divided into three groups (Acupuncture, Functional Taping and Acupuncture plus Functional Taping). The evaluation will consist of Isokinetic, Mini-Mental State Examination, Modified Ashworth Scale, Motor Activity Log, Wolf Motor Function Test and Visual Analog Scale of Pain. The results will be analyzed and presented descriptively, as of statistical comparisons of pre- and post-treatment and the relationship between the groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acupuncture Only | Active comparator | Procedure: AcupuncturePatients will be treated with acupuncture only. |
| Functional Taping Only | Active comparator | Other: Functional TapingPatients will be treated with taping only. |
| Acupuncture and Functional Taping | Experimental | Other: Acupuncture and Functional TapingPatients will be treated with both acupuncture and taping at the same session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with stroke diagnosis for at least six (06) months, who present hemiparesis in upper limb;
- To accept participate in the study by signing theTerms of Consent;
- Do not have any cognitive impairment.
Key exclusion criteria (3 listed)
- Do not follow the inclusion criteria;
- To present shoulder subluxation or dislocation, shoulder pain syndrome or amputations (with or without the use of aids);
- To present any allergic reaction due to use of bandage and/or do not adapt to treatment with needles.
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 |
|---|---|---|
| AcupunctureAcupuncture needles are inserted in specific acupuncture points on the boby (three points on both forearms and five points on the top of the head) for twenty minutes, three times a week, during twelve sessions. | Procedure or surgery | Acupuncture Only |
| Functional TapingElastic taping is positioned directly on the skin (on the back of the fingers, hand, forearm and arm - paretic upper limb), three times a week, during twelve sessions. The patient should keep the taping on the skin for two days. | Other | Functional Taping Only |
| Acupuncture and Functional TapingAcupuncture needles are inserted in specific acupuncture points on the boby (three points on both forearms and five points on the top of the head) for twenty minutes, then elastic taping is positioned directly on skin (on the back of the fingers, hand, forearm and arm - paretic upper limb). Both procedures are performed three times a week, during twelve sessions. | Other | Acupuncture and Functional Taping |
Primary outcome
The change of level of spasticity of upper limb after 12 sessions of intervention, assessed using the Modified Ashworth Scale
Time frame: Immediately before the first session of intervention and 2 days after the last (12th) session of intervention.
Modified Ashworth Scale
5 secondary outcomes
The change of functionality of upper limb after 12 sessions of intervention, assessed using the Wolf Motor Function Test
Time frame: Immediately before the first session of intervention and 2 days after the last (12th) session of intervention.
The change of frequency of movement of upper limb after 12 sessions of intervention
Time frame: Immediately before the first session of intervention and 2 days after the last (12th) session of intervention.
The change of quality of movement of upper limb after 12 sessions of intervention
Time frame: Immediately before the first session of intervention and 2 days after the last (12th) session of intervention.
The change of amplitude of movement after 12 sessions of intervention, assessed using Manual Goniometer
Time frame: Immediately before the first session of intervention and 2 days after the last (12th) session of intervention.
The change of level of pain in upper limb after 12 sessions of intervention, assessed using Visual Analogue Scale
Time frame: Immediately before the first session of intervention and 2 days after the last (12th) session of intervention.
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 29 Feb 2016.
- Background: PubMed 16699703Andrade FA, Pereira LV, Sousa FA. [Pain measurement in the elderly: a review]. Rev Lat Am Enfermagem. 2006 Mar-Apr;14(2):271-6. doi: 10.1590/s0104-11692006000200018. Epub 2006 May 8. Portuguese.
- BackgroundASSOCIAÇÃO BRASILEIRA DE MEDICINA FÍSICA E REABILITAÇÃO. Espasticidade: Avaliação Clínica. Projeto Diretrizes. 2006.
- BackgroundASSUMPÇAO, María Sebra de, et al. Coativação, Espasticidade, Desempenho Motor e Funcional na Paralisia Cerebral. Revista Motriz, v. 17, n. 4, out./dez. 2011, p. 650-659.
- Background: PubMed 25147752Belagaje SR, Lindsell C, Moomaw CJ, Alwell K, Flaherty ML, Woo D, Dunning K, Khatri P, Adeoye O, Kleindorfer D, Broderick J, Kissela B. The adverse effect of spasticity on 3-month poststroke outcome using a population-based model. Stroke Res Treat. 2014;2014:696089. doi: 10.1155/2014/696089. Epub 2014 Jul 24.
- Background: PubMed 25157219Bodhankar S, Chen Y, Lapato A, Vandenbark AA, Murphy SJ, Offner H. Targeting immune co-stimulatory effects of PD-L1 and PD-L2 might represent an effective therapeutic strategy in stroke. Front Cell Neurosci. 2014 Aug 11;8:228. doi: 10.3389/fncel.2014.00228. eCollection 2014.
- BackgroundBRANDÃO, Aline D.; LASKOVSKI, Larissa; GARANHANI, Márcia R. Estratégias de Fisioterapia com Enfoque na Prevenção da Dor no Ombro de Pacientes Hemiplégicos: Revisão Narrativa da Literatura. Fisioterapia em Movimento, v. 21, n. 4, p. 71-78, out./dez. 2008.
- BackgroundBROL, Angela M.; BORTOLOTO, Flavia; MAGAGNIN, Nedi M.S. Tratamento de Restrição e Indução do Movimento na Reabilitação Funcional de Pacientes Pós Acidente Vascular Encefálico: Uma Revisão Bibliográfica. Fisioterapia em Movimento, v. 22, n. 4, p. 497-509, out./dez. 2009.
- Background: PubMed 22634824Cabral DL, Damascena CG, Teixeira-Salmela LF, Laurentino GE. [Reliability of the Nottingham Health Profile after suffering a stroke]. Cien Saude Colet. 2012 May;17(5):1313-22. doi: 10.1590/s1413-81232012000500025. Portuguese.
- BackgroundCANCELA, Diana M. G. O Acidente Vascular Cerebral - Classificação, Principais Conseqüências e Reabilitação. Universidade Lusíada do Porto, 2008.
- BackgroundCORREIA, Andreza C. S. et al. Crioterapia e Cinesioterapia no Membro Superior Espástico no Acidente Vascular Cerebral. Fisioterapia em Movimento, v. 23, n. 4, p. 555-563, out./dez. 2010.
- BackgroundDUARTE, Alcino et al., Efeito da Crioterapia na Noção de Posição Articular Activa do Ombro: Um Estudo Comparativo Entre o Género Masculino e Feminino. Revista Portuguesa de Fisioterapia no Desporto, [2007].
- Background: PubMed 1202204Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.
- 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.
Rodrigo Della Méa Plentz, Doctor study director
Federal Universiity of Health Science of Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acupuncture, Functional Taping and Acupuncture and Functional Taping in people with Stroke and Cerebrovascular Stroke, run by Fernanda Cechetti 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 3 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 29 Feb 2016. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The change of level of spasticity of upper limb after 12 sessions of intervention, assessed using the Modified Ashworth Scale (time frame: Immediately before the first session of intervention and 2 days after the last (12th) session of intervention.). 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 NCT02690493, which also lists 56 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 29 Feb 2016.