StrokePhase 2NARLE1NCT02700061
Effects of Upper Limb Motor and Robotic Training Over Neuroplasticity and Function Capacity
A Phase 2 study testing Robotic occupational therapy and Induced Constraint Therapy - ICT in people with Stroke, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate and compare the effects of upper limb training with Induced Constraint Therapy (ICT) or robotic therapy. No placebo therapy is used. Motor function, neurological evaluations and quality of life are assessed for the comparison of the therapies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Robotic occupational therapy and Induced Constraint Therapy - ICT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2012to Feb 2017
- 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
- Clinical diagnosis of stroke;
- Patients from 6 months after stroke up to 36 months after stroke;
- Clinically stable;
- Upper limb Brunnstrom scale III or IV;
- Brunnstrom scale above V if clinician supports patients will benefit from treatment;
- Minimum wrist extension of 20°, and minimum of 10° of metacarpophalangeal active extension.
- Signed Informed Consent Form;
Who cannot join
- Mini-Mental score lower than 20 points;
- Previous multiple strokes;
- Bone diseases and articulation injuries ;
- Presence of psychological disturbances capable of diminishing adherence;
- Articulation pain within the range of motion proposed by the therapies;
- Participation in another study protocol for upper limbs therapies.
- Previous treatment with robotic assisted therapies.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Centro de Pesquisa Clínica do Instituto de Medicina Física e Reabilitação do HCFMUSP
São Paulo, São Paulo, 04116-040
About this study
Official title: Effects of Upper Limb Motor Training and Upper Limb Robotic Training Over Neuroplasticity and Function Capacity: A Single-blind Randomized Clinical Trial With Patients With Stroke Sequelae
The purpose of this study is to evaluate and compare the effects of upper limb training with Induced Constraint Therapy (ICT) or robotic therapy. No placebo therapy is used. Motor function, neurological evaluations and quality of life are assessed for the comparison of the therapies.
Read the detailed description
The trial is being carried out in the Institute of Physical Medicine and Rehabilitation of the University of São Paulo since February 2012. The investigators are including patients with clinical diagnosis of Ischemic or hemorrhagic stroke.
The patients are being randomized in blocks of four, six and eight, in two arms: ICT: patients are undergoing 60 minutes physiotherapy and occupational therapy twice a week for ten consecutive weeks. Other therapeutic services as phonoaudiology, psychology, nutrition, physical conditioning are prescribed upon the patients' medical demands. After the 10 weeks, the patients are undergoing two whole weeks of daily ICT as to reach 90% of the time under constraint, including weekends. During this last period, no other therapeutic service is offered, but the occupational therapy under ICT. Patients are not allowed to undergo robotic therapy.
Robotic therapy: patients are undergoing robotic occupational therapy for 60 minutes, three times a week for twelve consecutive weeks. All other therapeutic services are prescribed upon the patients' medical demands. Patients are not allowed to undergo ICT.
The investigator and the raters are blind to treatment.
The evaluations are done prior to the beginning of the treatment and at the end of it. The follow up assessments are done at 3 and 12 months after the end of the treatment.
The sample size was estimated to be 62 patients in each arm, a total size of 124 patients
- Conditions
- Stroke
- Being tested
- Robotic occupational therapy, Induced Constraint Therapy - ICT
- Keywords
- Induced Constraint Therapy, Robotic Occupational Therapy, Neuroplasticity
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic occupational therapyProcedure or surgery
Also called Robotic therapy
Robotic Occupational Therapy three times a week for twelve weeks.
Induced Constraint Therapy - ICTProcedure or surgery
Also called ICT
Standard Occupational Therapy two times a week for ten weeks, followed by two whole weeks of Induced Constraint Therapy.
| Study group | Role | What they receive |
|---|---|---|
| Induced Constraint Therapy - ICT | Experimental | Physical rehabilitation with Induced Constraint Therapy as part of the occupational therapy. Standard Occupational Therapy two times a week for ten weeks, followed by two whole weeks of Induced Constraint Therapy. Receives: Procedure: Induced Constraint Therapy - ICT |
| Robotic occupational therapy | Experimental | Physical rehabilitation with Robotic occupational therapy. Robotic Occupational Therapy three times a week for twelve weeks. Receives: Procedure: Robotic occupational therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on Motor Function assessed by Wolf Motor Function scale
Change from baseline in Wolf Motor Function scale.
Measured: Baseline and 12 weeks
Change on Motor Function assessed by Fugl Meyer scale
Change from baseline in Fugl Meyer scale.
Measured: Baseline and 12 weeks
Secondary outcomes (7)
Change on Motor Function assessed by Wolf Motor Function scale
Multiple changes from baseline in Wolf Motor Function scale.
Measured: Baseline, 3 months and 12 months
Change on Motor Function assessed by Fugl Meyer scale
Multiple changes from baseline in Fugl Meyer scale.
Measured: Baseline, 3 months and 12 months
Change on Motor Function assessed by Robotic scale
Multiple changes from baseline in robotic scale.
Measured: Baseline, 3 months and 12 months
Change on Function ability and quality of movement assessed by Arm Motor Ability Test (AMAT)
Multiple changes from baseline in AMAT scale.
Measured: Baseline, 12 weeks, 3 months and 12 months
Change on Functional Independence Measure (FIM) as assessed by FIM scale
Multiple changes from baseline in FIM scale.
Measured: Baseline, 12 weeks, 3 months and 12 months
Change on Quality of life assessed by Stroke Impact Scale (SIS)
Multiple changes from baseline in SIS.
Measured: Baseline, 12 weeks, 3 months and 12 months
Change on Kinematic variables assessed by InMotion robots
Multiple motion changes from baseline in the Kinematic variables assessed by InMotion robots.
Measured: Baseline, 12 weeks, 3 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2016 (estimated)
- Study startFeb 2012
- Primary completionApr 2016 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Paulo General HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Linamara Rizzo Battistella, Md PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02700061
- Sponsor's protocol ID
- 0910.0.015.000-11
- Acronym
- NARLE1
- Status last verified
- Aug 2015
- First submitted
- 24 Nov 2015
- Last updated
- 7 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Terranova TT, Simis M, Santos ACA, Alfieri FM, Imamura M, Fregni F, Battistella LR. Robot-Assisted Therapy and Constraint-Induced Movement Therapy for Motor Recovery in Stroke: Results From a Randomized Clinical Trial. Front Neurorobot. 2021 Jul 21;15:684019. doi: 10.3389/fnbot.2021.684019. eCollection 2021.
PubMed 34366819
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Upper Limb Motor Training and Upper Limb Robotic Training Over Neuroplasticity and Function Capacity: A Single-blind Randomized Clinical Trial With Patients With Stroke Sequelae
- ClinicalTrials.gov ID
- NCT02700061
- Acronym / sponsor ID
- NARLE1 / 0910.0.015.000-11
- Conditions
- Stroke
- Keywords
- Induced Constraint Therapy, Robotic Occupational Therapy, Neuroplasticity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 7 Mar 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 evaluate and compare the effects of upper limb training with Induced Constraint Therapy (ICT) or robotic therapy. No placebo therapy is used. Motor function, neurological evaluations and quality of life are assessed for the comparison of the therapies.
Detailed description
The trial is being carried out in the Institute of Physical Medicine and Rehabilitation of the University of São Paulo since February 2012. The investigators are including patients with clinical diagnosis of Ischemic or hemorrhagic stroke.
The patients are being randomized in blocks of four, six and eight, in two arms: ICT: patients are undergoing 60 minutes physiotherapy and occupational therapy twice a week for ten consecutive weeks. Other therapeutic services as phonoaudiology, psychology, nutrition, physical conditioning are prescribed upon the patients' medical demands. After the 10 weeks, the patients are undergoing two whole weeks of daily ICT as to reach 90% of the time under constraint, including weekends. During this last period, no other therapeutic service is offered, but the occupational therapy under ICT. Patients are not allowed to undergo robotic therapy.
Robotic therapy: patients are undergoing robotic occupational therapy for 60 minutes, three times a week for twelve consecutive weeks. All other therapeutic services are prescribed upon the patients' medical demands. Patients are not allowed to undergo ICT.
The investigator and the raters are blind to treatment.
The evaluations are done prior to the beginning of the treatment and at the end of it. The follow up assessments are done at 3 and 12 months after the end of the treatment.
The sample size was estimated to be 62 patients in each arm, a total size of 124 patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Induced Constraint Therapy - ICT | Experimental | Procedure: Induced Constraint Therapy - ICTPhysical rehabilitation with Induced Constraint Therapy as part of the occupational therapy. Standard Occupational Therapy two times a week for ten weeks, followed by two whole weeks of Induced Constraint Therapy. |
| Robotic occupational therapy | Experimental | Procedure: Robotic occupational therapyPhysical rehabilitation with Robotic occupational therapy. Robotic Occupational Therapy three times a week for twelve weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Clinical diagnosis of stroke;
- Patients from 6 months after stroke up to 36 months after stroke;
- Clinically stable;
- Upper limb Brunnstrom scale III or IV;
- Brunnstrom scale above V if clinician supports patients will benefit from treatment;
Key exclusion criteria (7 listed)
- Mini-Mental score lower than 20 points;
- Previous multiple strokes;
- Bone diseases and articulation injuries ;
- Presence of psychological disturbances capable of diminishing adherence;
- Articulation pain within the range of motion proposed by the therapies;
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 |
|---|---|---|
| Robotic occupational therapyAlso: Robotic therapyRobotic Occupational Therapy three times a week for twelve weeks. | Procedure or surgery | Robotic occupational therapy |
| Induced Constraint Therapy - ICTAlso: ICTStandard Occupational Therapy two times a week for ten weeks, followed by two whole weeks of Induced Constraint Therapy. | Procedure or surgery | Induced Constraint Therapy - ICT |
Primary outcome
Change on Motor Function assessed by Wolf Motor Function scale
Time frame: Baseline and 12 weeks
Change from baseline in Wolf Motor Function scale.
Change on Motor Function assessed by Fugl Meyer scale
Time frame: Baseline and 12 weeks
Change from baseline in Fugl Meyer scale.
7 secondary outcomes
Change on Motor Function assessed by Wolf Motor Function scale
Time frame: Baseline, 3 months and 12 months
Change on Motor Function assessed by Fugl Meyer scale
Time frame: Baseline, 3 months and 12 months
Change on Motor Function assessed by Robotic scale
Time frame: Baseline, 3 months and 12 months
Change on Function ability and quality of movement assessed by Arm Motor Ability Test (AMAT)
Time frame: Baseline, 12 weeks, 3 months and 12 months
Change on Functional Independence Measure (FIM) as assessed by FIM scale
Time frame: Baseline, 12 weeks, 3 months and 12 months
Change on Quality of life assessed by Stroke Impact Scale (SIS)
Time frame: Baseline, 12 weeks, 3 months and 12 months
Change on Kinematic variables assessed by InMotion robots
Time frame: Baseline, 12 weeks, 3 months and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2016.
- Derived from this study: PubMed 34366819Terranova TT, Simis M, Santos ACA, Alfieri FM, Imamura M, Fregni F, Battistella LR. Robot-Assisted Therapy and Constraint-Induced Movement Therapy for Motor Recovery in Stroke: Results From a Randomized Clinical Trial. Front Neurorobot. 2021 Jul 21;15:684019. doi: 10.3389/fnbot.2021.684019. eCollection 2021.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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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.
Linamara Rizzo Battistella, Md PhD 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 Phase 2 study testing Robotic occupational therapy and Induced Constraint Therapy - ICT in people with Stroke, 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 7 inclusion and 7 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 7 Mar 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?
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?
Change on Motor Function assessed by Wolf Motor Function scale (time frame: Baseline and 12 weeks). The study lists 2 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 NCT02700061, which also lists 1 linked publication.
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 7 Mar 2016.