StrokeNCT03469778
Assessment of a Upper Limb Robotic Device in Stroke Patients
A study testing Robotic Therapy in people with Stroke, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The objectives of this phase II clinical study are: evaluate the efficacy, safety, patient adeherence and clinical applicability of a new robotic device for patients with stroke at a physical rehabilitation institution (Instituto de Medicina Física e Reabilitação do Hospital das Clínicas da Universidade de São Paulo … Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- Robotic Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- 2 May 2018to Sep 2018
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Joint, muscle or tendinous lesions and/or pain that can occur during the intervention and make it difficult or impossible to perform robotic tasks.
- Progressive worsening of spasticity.
- Withdrawal of the informed consent form.
- New episode of stroke.
- Comorbidities that may occur during interventions such as hypertension, seizures, diabetes, among other uncontrolled clinical issues.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Centro de Pesquisa Clínica - Instituto de Medicina Física e Reabilitação
São Paulo, 04116-040
Thais Tavares Terranova, 5180-7800 ext. 7897, thais.terranova@gmail.com
Artur César Aquino dos Santos, 5180-7800 ext. 7897, artur.santos@hc.fm.usp.br
About this study
The objectives of this phase II clinical study are: evaluate the efficacy, safety, patient adeherence and clinical applicability of a new robotic device for patients with stroke at a physical rehabilitation institution (Instituto de Medicina Física e Reabilitação do Hospital das Clínicas da Universidade de São Paulo - IMREA HCFMUSP - Rede de Reabilitação Lucy Montoro, unidade Vila Mariana). Methods: 10 patients with stroke diagnosis and Fugl-Meyer score ranging from 34 to 55 will be selected to be included in the study. After signing the informed consent form and being assessed by the baseline evaluations, they will undertake 18 sessions of robotic therapy, which in its turn will be prescribed three times a week. After this period, the patients will be evaluated for future comparison of both the pre-treatment and final assessments.
- Conditions
- Stroke
- Being tested
- Robotic Therapy
- Keywords
- stroke, rehabilitation, upper limb, motor activity, robotic
- Medical subject headings
- Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic TherapyDevice
Robotic Therapy
| Study group | Role | What they receive |
|---|---|---|
| Robotic Therapy | Experimental | After consent, 10 participants will be included in a training program, as described below: 1º session will be robotic calibration and assessment; the following 18 sessions will be conducted the robotic therapy for upper limbs, three times a week. Each session will have a total duration of 55 minutes, including initial patient positioning and adjusting and after a sequence of game tasks. Receives: Device: Robotic Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl Meyer Assessment Upper Limb (FMA-UL)
FMA-UL evaluates the recovery of the hemiplegic patient after stroke. It includes the measurement of reflex activity, movement with and without synergy, voluntary movements and coordination of shoulder, elbow, wrist, hand.
Measured: Mean change from baseline at six weeks (19 sessions of robotic therapy).
Secondary outcomes (4)
Wolf Motor Function Test (WMFT)
WMFT evaluates time performance and functional ability in 17 unimanual tasks.
Measured: Mean change from baseline at six weeks (19 sessions of robotic therapy).
Dynamometry - Grasp and Pinch
Instrument to measure palmar and lateral grip (strength in kgf).
Measured: Mean change from baseline at six weeks (19 sessions of robotic therapy).
Patients safety
Adverse effects questionnaire applied in each session.
Measured: Adverse effects reported during 6 weeks treatment.
Treatment adherence
Number of patients withdrawing from treatment without justification (drop outs).
Measured: Drop outs reported during 6 weeks treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start2 May 2018 (estimated)
- Primary completionJul 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03469778
- Sponsor's protocol ID
- 71611217.5.0000.0068
- Status last verified
- Dec 2017
- First submitted
- 12 Mar 2018
- Last updated
- 19 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of a Upper Limb Robotic Device in Stroke Patients
- ClinicalTrials.gov ID
- NCT03469778
- Acronym / sponsor ID
- 71611217.5.0000.0068
- Conditions
- Stroke
- Keywords
- stroke, rehabilitation, upper limb, motor activity, robotic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 2 May 2018 (estimated)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 19 Mar 2018 (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 objectives of this phase II clinical study are: evaluate the efficacy, safety, patient adeherence and clinical applicability of a new robotic device for patients with stroke at a physical rehabilitation institution (Instituto de Medicina Física e Reabilitação do Hospital das Clínicas da Universidade de São Paulo - IMREA HCFMUSP - Rede de Reabilitação Lucy Montoro, unidade Vila Mariana). Methods: 10 patients with stroke diagnosis and Fugl-Meyer score ranging from 34 to 55 will be selected to be included in the study. After signing the informed consent form and being assessed by the baseline evaluations, they will undertake 18 sessions of robotic therapy, which in its turn will be prescribed three times a week. After this period, the patients will be evaluated for future comparison of both the pre-treatment and final assessments.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic Therapy | Experimental | Device: Robotic TherapyAfter consent, 10 participants will be included in a training program, as described below: 1º session will be robotic calibration and assessment; the following 18 sessions will be conducted the robotic therapy for upper limbs, three times a week. Each session will have a total duration of 55 minutes, including initial patient positioning and adjusting and after a sequence of game tasks. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Joint, muscle or tendinous lesions and/or pain that can occur during the intervention and make it difficult or impossible to perform robotic tasks.
- Progressive worsening of spasticity.
- Withdrawal of the informed consent form.
- New episode of stroke.
- Comorbidities that may occur during interventions such as hypertension, seizures, diabetes, among other uncontrolled clinical issues.
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 TherapyRobotic Therapy | Device | Robotic Therapy |
Primary outcome
Fugl Meyer Assessment Upper Limb (FMA-UL)
Time frame: Mean change from baseline at six weeks (19 sessions of robotic therapy).
FMA-UL evaluates the recovery of the hemiplegic patient after stroke. It includes the measurement of reflex activity, movement with and without synergy, voluntary movements and coordination of shoulder, elbow, wrist, hand.
4 secondary outcomes
Wolf Motor Function Test (WMFT)
Time frame: Mean change from baseline at six weeks (19 sessions of robotic therapy).
Dynamometry - Grasp and Pinch
Time frame: Mean change from baseline at six weeks (19 sessions of robotic therapy).
Patients safety
Time frame: Adverse effects reported during 6 weeks treatment.
Treatment adherence
Time frame: Drop outs reported during 6 weeks treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2018.
- 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.
Centro de Pesquisa Clínica - Instituto de Medicina Física e Reabilitação
São Paulo, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic Therapy 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 0 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: status not confirmed, as of the sponsor's last update on 19 Mar 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl Meyer Assessment Upper Limb (FMA-UL) (time frame: Mean change from baseline at six weeks (19 sessions of robotic therapy).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Mar 2018.