An interventional study of Robotic Therapy in Stroke, sponsored by University of Sao Paulo General Hospital. Status unknown at 1 site in Brazil. Open to participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-03-19.
Sponsored by University of Sao Paulo General Hospital · Not applicable, Interventional, and Device feasibility
Among 16 studies in Stroke by University of Sao Paulo General Hospital — none open to participants now, 1 under way, none of them phase 3. Stroke · University of Sao Paulo General Hospital.
Among the 16 studies in Stroke by University of Sao Paulo General Hospital, this one is the 11th largest by planned enrollment of the 13 interventional ones that give a count, is the only one that started in 2018, is one of 10 with no phase, and was the 15th registered.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
Browse Stroke studies →None of the 16 studies in Stroke by University of Sao Paulo General Hospital is open now.
Of the 1,415 Stroke studies recruiting now, 697 (49%) set no upper age limit and 280 (20%) stop at 75 or younger; 77 take children under 18; 196 take healthy volunteers.
This study: 40 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
16 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 2
First in 2007; this study’s year is marked. 1 started in 2018.
This study's planned enrollment of 10 is below the median of 49 across 6,024 interventional studies indexed under Stroke.
Median enrollment 32 across the 13 interventional studies, 49 across the 3 observational. Of the 10 that completed or were terminated, 2 (20%) have results posted.
This tab as a report to print or save as PDF → With an account.
University of Sao Paulo General Hospital is the lead sponsor of 611 studies on the registry; 98 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 16 studies in Stroke by University of Sao Paulo General Hospital, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
Inlcusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Robotic Therapy
Robotic Therapy
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.
Time frame: Mean change from baseline at six weeks (19 sessions of robotic therapy).
Wolf Motor Function Test (WMFT)
WMFT evaluates time performance and functional ability in 17 unimanual tasks.
Time frame: 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).
Time frame: Mean change from baseline at six weeks (19 sessions of robotic therapy).
Patients safety
Adverse effects questionnaire applied in each session.
Time frame: Adverse effects reported during 6 weeks treatment.
Treatment adherence
Number of patients withdrawing from treatment without justification (drop outs).
Time frame: Drop outs reported during 6 weeks treatment.
Clinical feasibility
Time necessary to adjust the device; patients satisfaction questionnaire.
Time frame: Reported during 6 weeks treatment, in each session.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for May 2018; primary completion for Jul 2018, 2 months later.
Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's planned 2 months is below that.
Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Sao Paulo General Hospital →