Stroke
Conditions
Keywords
stroke, rehabilitation, upper limb, motor activity, robotic
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.
Interventions
DEVICERobotic Therapy
Robotic Therapy
Sponsors
University of Sao Paulo General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl Meyer Assessment Upper Limb (FMA-UL) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wolf Motor Function Test (WMFT) | Mean change from baseline at six weeks (19 sessions of robotic therapy). | WMFT evaluates time performance and functional ability in 17 unimanual tasks. |
| Dynamometry - Grasp and Pinch | Mean change from baseline at six weeks (19 sessions of robotic therapy). | Instrument to measure palmar and lateral grip (strength in kgf). |
| Patients safety | Adverse effects reported during 6 weeks treatment. | Adverse effects questionnaire applied in each session. |
| Treatment adherence | Drop outs reported during 6 weeks treatment. | Number of patients withdrawing from treatment without justification (drop outs). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Clinical feasibility | Reported during 6 weeks treatment, in each session. | Time necessary to adjust the device; patients satisfaction questionnaire. |
Countries
Brazil
Outcome results
None listed