Clinical trial NCT03469778: Assessment of a Upper Limb Robotic Device in Stroke Patients
Official title: Assessment of a Upper Limb Robotic Device in Stroke Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: stroke
rehabilitation
upper limb
motor activity
robotic
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2018-03-19
Enrollment: 10
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief 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 - 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.


Eligibility criteria: Inlcusion Criteria:

1. Between 40 and 65 years.
2. Both genders.
3. Clinical and radiological diagnosis of ischemic stroke in the vascular territory of the middle cerebral artery or anterior cerebral artery.
4. Clinical assessment of disability with diagnosis of right or left hemiparesis.
5. Onset between 24 and 36 months.
6. Clinical stability verified in medical evaluation.
7. Spasticity less than or equal to 2 in Modified Ashworth Scale.
8. Moderate motor impairment in upper limb, according to Fugl-Meyer Assessment Upper Limb score (34 to 55 points).
9. To remain seated in a backrest chair during the intervention period (about 55 minutes).
10. Acceptance of informed consent form to participate in the study.

Exclusion Criteria:

1. Joint, muscle or tendinous lesions and/or pain that can occur during the intervention and make it difficult or impossible to perform robotic tasks.
2. Progressive worsening of spasticity.
3. Withdrawal of the informed consent form.
4. New episode of stroke.
5. Comorbidities that may occur during interventions such as hypertension, seizures, diabetes, among other uncontrolled clinical issues.

Primary outcomes:
measure: Fugl Meyer Assessment Upper Limb (FMA-UL)
timeFrame: Mean change from baseline at six weeks (19 sessions of robotic therapy).
Secondary outcomes:
measure: Wolf Motor Function Test (WMFT)
timeFrame: Mean change from baseline at six weeks (19 sessions of robotic therapy).
measure: Dynamometry - Grasp and Pinch
timeFrame: Mean change from baseline at six weeks (19 sessions of robotic therapy).
measure: Patients safety
timeFrame: Adverse effects reported during 6 weeks treatment.
measure: Treatment adherence
timeFrame: Drop outs reported during 6 weeks treatment.
Other outcomes:
measure: Clinical feasibility
timeFrame: Reported during 6 weeks treatment, in each session.
Locations:
city: São Paulo
country: Brazil
facility: Centro de Pesquisa Clínica - Instituto de Medicina Física e Reabilitação
Study officials:
References: