StrokeNCT02441374
Efficacy of Modified FUT Protocols in Relation to CR Protocol
A study testing Tubular mesh. and Classical kinesiotherapy. in people with Stroke, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
There are some treatments after Stroke. Among these, use forced therapy (FUT), which is based on overcoming learned disuse by reintroduction of the paretic upper limb in the performance of daily activities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Tubular mesh. and Classical kinesiotherapy.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2016to Jan 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Good cognition,
- Absence of joint blocks,
- Good range of motion in upper limb with at least 20º of active extension of the wrist and 10º in the metacarpal phalangeal,
- Joint and walking capacity without assistance.
Who cannot join
- Heart arrhythmia,
- Hypertension,
- Severe cardiovascular and respiratory problems,
- Inability to attend the sessions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Modified FUT Protocols With 12 and 24 Hours of Upper Limb Immobilization in Relation to CR Arm Protocol.
There are some treatments after Stroke. Among these, use forced therapy (FUT), which is based on overcoming learned disuse by reintroduction of the paretic upper limb in the performance of daily activities. There are different protocols FUT to the daily time constraint, the number of days and even the type of constriction. Researchers have developed a protocol using four weeks constriction, daily constriction 24 hours and with the free end of the weekends. Because it is a restrictive therapy, which requires the use of one of the arms and on the other hand, this mode of treatment is open to criticism, however, despite the efficacy of the protocol, patients do not have good adhesion to the protocol for the constriction severe over time. The objective of this work is to verify the safety of the developed protocol and analyze the feasibility of reducing the daily time of constriction 12 hours, with a new protocol movement constriction, easier to perform and more patient acceptance. Participate in this study 82 individuals hemiparetic post Stroke, which will be recruited to Neurovascular Diseases Clinic and will be registered at the Rehabilitation Center of Integrated State Hospital. Participants will be randomly divided into three groups: the FUT24 (non-paretic upper limb constriction 24 hours a day, five days a week for 4 weeks), the FUT 12 (non-paretic upper limb constriction for 12 hours a day, five days a week for 4 weeks) and CK (Classic Kinesiotherapy, at least 2 times a week for 4 weeks). Will be held weekly and after the end of the monthly monitoring reviews protocols. For the rating scales are use: National Institute of Health Stroke Scale, the Ashworth Scale, the Wolf Motor Function Test, the Motor Activity Log, Fugl-Meyer Assesment, dynamometry handgrip and surface electromyography (flexor and extensor muscles wrist). The researchers hope that this protocol does not bring damage to the upper limb in constriction and it is established a new protocol FUT easier to perform and more acceptable to patients, allowing the use of this technique by health professionals.
Read the detailed description
The constriction of the non-paretic upper limb will be conducted through a tubular mesh with UL positioned in adduction and shoulder internal rotation and elbow flexion greater than 90º in FUT 24 and FUT 12 groups. Daily, the mesh is withdrawn by the investigators made hygienic, and the new constraint is accomplished using a new tubular mesh.The Classic Kinesiotherapy Group,which will receive as a treatment only kinesiotherapy.
- Conditions
- Stroke
- Being tested
- Tubular mesh., Classical kinesiotherapy.
- Keywords
- Stroke, Hemiparesis, Upper limb
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tubular mesh.Device
Rehabilitation in upper limb during and after applying of FUT (through the tubular mesh) post stroke.
Classical kinesiotherapy.Other
Applying classical kinesiotherapy in upper limb post stroke.
| Study group | Role | What they receive |
|---|---|---|
| Forced Use Therapy | Experimental | Constriction (through the tubular mesh) of non paretic upper limb for a period of 12 and 24 hours, 5 days per week for 4 weeks. Receives: Device: Tubular mesh. |
| Classical Kinesiotherapy | Active comparator | Rehabilitation of classical kinesiotherapy,at least 2 times a week for 4 weeks. Receives: Other: Classical kinesiotherapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of RMS activity through surface electromyography.
Evaluations shall be performed weekly during the treatment period and 1 monthly assessment for 3 months after the protocol without therapeutic intervention.
Measured: 4 months
Secondary outcomes (1)
Evaluate the strength handgrip (Kgf) of hemiparetic patients submitted to FUT post stroke.
Evaluations shall be performed weekly during the treatment period and 1 monthly assessment for 3 months after the protocol without therapeutic intervention.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startAug 2016
- Primary completionMay 2017
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamyris Padovani dos Santos, University of Sao Paulo
- Investigators
- Tamyris Padovani dos Santos, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02441374
- Sponsor's protocol ID
- TPSantos
- Status last verified
- Aug 2019
- First submitted
- 9 Apr 2015
- Last updated
- 30 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ahmed S, Mayo NE, Higgins J, Salbach NM, Finch L, Wood-Dauphinee SL. The Stroke Rehabilitation Assessment of Movement (STREAM): a comparison with other measures used to evaluate effects of stroke and rehabilitation. Phys Ther. 2003 Jul;83(7):617-30.
PubMed 12837123Brown MM. Brain attack: a new approach to stroke. Clin Med (Lond). 2002 Jan-Feb;2(1):60-5. doi: 10.7861/clinmedicine.2-1-60.
PubMed 11871641Brott T, Adams HP Jr, Olinger CP, Marler JR, Barsan WG, Biller J, Spilker J, Holleran R, Eberle R, Hertzberg V, et al. Measurements of acute cerebral infarction: a clinical examination scale. Stroke. 1989 Jul;20(7):864-70. doi: 10.1161/01.str.20.7.864.
PubMed 2749846Cincura C, Pontes-Neto OM, Neville IS, Mendes HF, Menezes DF, Mariano DC, Pereira IF, Teixeira LA, Jesus PA, de Queiroz DC, Pereira DF, Pinto E, Leite JP, Lopes AA, Oliveira-Filho J. Validation of the National Institutes of Health Stroke Scale, modified Rankin Scale and Barthel Index in Brazil: the role of cultural adaptation and structured interviewing. Cerebrovasc Dis. 2009;27(2):119-22. doi: 10.1159/000177918. Epub 2008 Nov 28.
PubMed 19039215Charles J, Gordon AM. A critical review of constraint-induced movement therapy and forced use in children with hemiplegia. Neural Plast. 2005;12(2-3):245-61; discussion 263-72. doi: 10.1155/NP.2005.245.
PubMed 16097492Cirstea MC, Levin MF. Improvement of arm movement patterns and endpoint control depends on type of feedback during practice in stroke survivors. Neurorehabil Neural Repair. 2007 Sep-Oct;21(5):398-411. doi: 10.1177/1545968306298414. Epub 2007 Mar 16.
PubMed 17369514De Marchis GM, Foderaro G, Jemora J, Zanchi F, Altobianchi A, Biglia E, Conti FM, Monotti R, Mombelli G. Mild cognitive impairment in medical inpatients: the Mini-Mental State Examination is a promising screening tool. Dement Geriatr Cogn Disord. 2010;29(3):259-64. doi: 10.1159/000288772. Epub 2010 Apr 6.
PubMed 20375507De D, Wynn E. Preventing muscular contractures through routine stroke patient care. Br J Nurs. 2014 Jul 24-Aug 13;23(14):781-6. doi: 10.12968/bjon.2014.23.14.781.
PubMed 25062313Feigin VL, Barker-Collo S, Krishnamurthi R, Theadom A, Starkey N. Epidemiology of ischaemic stroke and traumatic brain injury. Best Pract Res Clin Anaesthesiol. 2010 Dec;24(4):485-94. doi: 10.1016/j.bpa.2010.10.006. Epub 2010 Nov 29.
PubMed 21619861Fuzaro AC, Guerreiro CT, Galetti FC, Juca RB, Araujo JE. Modified constraint-induced movement therapy and modified forced-use therapy for stroke patients are both effective to promote balance and gait improvements. Rev Bras Fisioter. 2012 Apr;16(2):157-65. doi: 10.1590/s1413-35552012005000010. Epub 2012 Mar 1.
PubMed 22378476Green J, Forster A, Young J. Reliability of gait speed measured by a timed walking test in patients one year after stroke. Clin Rehabil. 2002 May;16(3):306-14. doi: 10.1191/0269215502cr495oa.
PubMed 12017517Hagg S, Thorn LM, Forsblom CM, Gordin D, Saraheimo M, Tolonen N, Waden J, Liebkind R, Putaala J, Tatlisumak T, Groop PH; FinnDiane Study Group. Different risk factor profiles for ischemic and hemorrhagic stroke in type 1 diabetes mellitus. Stroke. 2014 Sep;45(9):2558-62. doi: 10.1161/STROKEAHA.114.005724. Epub 2014 Jul 24.
PubMed 25061078Lavados PM, Hennis AJ, Fernandes JG, Medina MT, Legetic B, Hoppe A, Sacks C, Jadue L, Salinas R. Stroke epidemiology, prevention, and management strategies at a regional level: Latin America and the Caribbean. Lancet Neurol. 2007 Apr;6(4):362-72. doi: 10.1016/S1474-4422(07)70003-0.
PubMed 17362840Liepert J, Uhde I, Graf S, Leidner O, Weiller C. Motor cortex plasticity during forced-use therapy in stroke patients: a preliminary study. J Neurol. 2001 Apr;248(4):315-21. doi: 10.1007/s004150170207.
PubMed 11374097Michaelsen SM, Rocha AS, Knabben RJ, Rodrigues LP, Fernandes CG. Translation, adaptation and inter-rater reliability of the administration manual for the Fugl-Meyer assessment. Rev Bras Fisioter. 2011 Jan-Feb;15(1):80-8.
PubMed 21519719
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Modified FUT Protocols With 12 and 24 Hours of Upper Limb Immobilization in Relation to CR Arm Protocol.
- ClinicalTrials.gov ID
- NCT02441374
- Acronym / sponsor ID
- TPSantos
- Conditions
- Stroke
- Keywords
- Stroke, Hemiparesis, Upper limb
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- May 2017 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 12 May 2015 (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.
There are some treatments after Stroke. Among these, use forced therapy (FUT), which is based on overcoming learned disuse by reintroduction of the paretic upper limb in the performance of daily activities. There are different protocols FUT to the daily time constraint, the number of days and even the type of constriction. Researchers have developed a protocol using four weeks constriction, daily constriction 24 hours and with the free end of the weekends. Because it is a restrictive therapy, which requires the use of one of the arms and on the other hand, this mode of treatment is open to criticism, however, despite the efficacy of the protocol, patients do not have good adhesion to the protocol for the constriction severe over time. The objective of this work is to verify the safety of the developed protocol and analyze the feasibility of reducing the daily time of constriction 12 hours, with a new protocol movement constriction, easier to perform and more patient acceptance. Participate in this study 82 individuals hemiparetic post Stroke, which will be recruited to Neurovascular Diseases Clinic and will be registered at the Rehabilitation Center of Integrated State Hospital. Participants will be randomly divided into three groups: the FUT24 (non-paretic upper limb constriction 24 hours a day, five days a week for 4 weeks), the FUT 12 (non-paretic upper limb constriction for 12 hours a day, five days a week for 4 weeks) and CK (Classic Kinesiotherapy, at least 2 times a week for 4 weeks). Will be held weekly and after the end of the monthly monitoring reviews protocols. For the rating scales are use: National Institute of Health Stroke Scale, the Ashworth Scale, the Wolf Motor Function Test, the Motor Activity Log, Fugl-Meyer Assesment, dynamometry handgrip and surface electromyography (flexor and extensor muscles wrist). The researchers hope that this protocol does not bring damage to the upper limb in constriction and it is established a new protocol FUT easier to perform and more acceptable to patients, allowing the use of this technique by health professionals.
Detailed description
The constriction of the non-paretic upper limb will be conducted through a tubular mesh with UL positioned in adduction and shoulder internal rotation and elbow flexion greater than 90º in FUT 24 and FUT 12 groups. Daily, the mesh is withdrawn by the investigators made hygienic, and the new constraint is accomplished using a new tubular mesh.The Classic Kinesiotherapy Group,which will receive as a treatment only kinesiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Forced Use Therapy | Experimental | Device: Tubular mesh.Constriction (through the tubular mesh) of non paretic upper limb for a period of 12 and 24 hours, 5 days per week for 4 weeks. |
| Classical Kinesiotherapy | Active comparator | Other: Classical kinesiotherapy.Rehabilitation of classical kinesiotherapy,at least 2 times a week for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Good cognition,
- Absence of joint blocks,
- Good range of motion in upper limb with at least 20º of active extension of the wrist and 10º in the metacarpal phalangeal,
- Joint and walking capacity without assistance.
Key exclusion criteria (4 listed)
- Heart arrhythmia,
- Hypertension,
- Severe cardiovascular and respiratory problems,
- Inability to attend the sessions.
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 |
|---|---|---|
| Tubular mesh.Rehabilitation in upper limb during and after applying of FUT (through the tubular mesh) post stroke. | Device | Forced Use Therapy |
| Classical kinesiotherapy.Applying classical kinesiotherapy in upper limb post stroke. | Other | Classical Kinesiotherapy |
Primary outcome
Evaluation of RMS activity through surface electromyography.
Time frame: 4 months
Evaluations shall be performed weekly during the treatment period and 1 monthly assessment for 3 months after the protocol without therapeutic intervention.
1 secondary outcome
Evaluate the strength handgrip (Kgf) of hemiparetic patients submitted to FUT post stroke.
Time frame: 4 months
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 30 Aug 2019.
- Results publication: PubMed 12837123Ahmed S, Mayo NE, Higgins J, Salbach NM, Finch L, Wood-Dauphinee SL. The Stroke Rehabilitation Assessment of Movement (STREAM): a comparison with other measures used to evaluate effects of stroke and rehabilitation. Phys Ther. 2003 Jul;83(7):617-30.
- Results publication: PubMed 11871641Brown MM. Brain attack: a new approach to stroke. Clin Med (Lond). 2002 Jan-Feb;2(1):60-5. doi: 10.7861/clinmedicine.2-1-60.
- Results publication: PubMed 2749846Brott T, Adams HP Jr, Olinger CP, Marler JR, Barsan WG, Biller J, Spilker J, Holleran R, Eberle R, Hertzberg V, et al. Measurements of acute cerebral infarction: a clinical examination scale. Stroke. 1989 Jul;20(7):864-70. doi: 10.1161/01.str.20.7.864.
- Results publication: PubMed 19039215Cincura C, Pontes-Neto OM, Neville IS, Mendes HF, Menezes DF, Mariano DC, Pereira IF, Teixeira LA, Jesus PA, de Queiroz DC, Pereira DF, Pinto E, Leite JP, Lopes AA, Oliveira-Filho J. Validation of the National Institutes of Health Stroke Scale, modified Rankin Scale and Barthel Index in Brazil: the role of cultural adaptation and structured interviewing. Cerebrovasc Dis. 2009;27(2):119-22. doi: 10.1159/000177918. Epub 2008 Nov 28.
- Results publication: PubMed 16097492Charles J, Gordon AM. A critical review of constraint-induced movement therapy and forced use in children with hemiplegia. Neural Plast. 2005;12(2-3):245-61; discussion 263-72. doi: 10.1155/NP.2005.245.
- Results publication: PubMed 17369514Cirstea MC, Levin MF. Improvement of arm movement patterns and endpoint control depends on type of feedback during practice in stroke survivors. Neurorehabil Neural Repair. 2007 Sep-Oct;21(5):398-411. doi: 10.1177/1545968306298414. Epub 2007 Mar 16.
- Results publication: PubMed 20375507De Marchis GM, Foderaro G, Jemora J, Zanchi F, Altobianchi A, Biglia E, Conti FM, Monotti R, Mombelli G. Mild cognitive impairment in medical inpatients: the Mini-Mental State Examination is a promising screening tool. Dement Geriatr Cogn Disord. 2010;29(3):259-64. doi: 10.1159/000288772. Epub 2010 Apr 6.
- Results publication: PubMed 25062313De D, Wynn E. Preventing muscular contractures through routine stroke patient care. Br J Nurs. 2014 Jul 24-Aug 13;23(14):781-6. doi: 10.12968/bjon.2014.23.14.781.
- Results publication: PubMed 21619861Feigin VL, Barker-Collo S, Krishnamurthi R, Theadom A, Starkey N. Epidemiology of ischaemic stroke and traumatic brain injury. Best Pract Res Clin Anaesthesiol. 2010 Dec;24(4):485-94. doi: 10.1016/j.bpa.2010.10.006. Epub 2010 Nov 29.
- Results publication: PubMed 22378476Fuzaro AC, Guerreiro CT, Galetti FC, Juca RB, Araujo JE. Modified constraint-induced movement therapy and modified forced-use therapy for stroke patients are both effective to promote balance and gait improvements. Rev Bras Fisioter. 2012 Apr;16(2):157-65. doi: 10.1590/s1413-35552012005000010. Epub 2012 Mar 1.
- Results publication: PubMed 12017517Green J, Forster A, Young J. Reliability of gait speed measured by a timed walking test in patients one year after stroke. Clin Rehabil. 2002 May;16(3):306-14. doi: 10.1191/0269215502cr495oa.
- Results publication: PubMed 25061078Hagg S, Thorn LM, Forsblom CM, Gordin D, Saraheimo M, Tolonen N, Waden J, Liebkind R, Putaala J, Tatlisumak T, Groop PH; FinnDiane Study Group. Different risk factor profiles for ischemic and hemorrhagic stroke in type 1 diabetes mellitus. Stroke. 2014 Sep;45(9):2558-62. doi: 10.1161/STROKEAHA.114.005724. Epub 2014 Jul 24.
- 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.
Tamyris Padovani dos Santos principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tubular mesh. and Classical kinesiotherapy. in people with Stroke, run by University of Sao Paulo 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 4 inclusion and 4 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 30 Aug 2019. 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.
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?
Evaluation of RMS activity through surface electromyography. (time frame: 4 months). 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 NCT02441374, which also lists 20 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 30 Aug 2019.