Assessment of a Upper Limb Robotic Device in Stroke Patients

Study Overview
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Brief Summary
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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.

Official Title
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Assessment of a Upper Limb Robotic Device in Stroke Patients

Conditions
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Stroke

Intervention / Treatment
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* Device: Robotic Therapy


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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robotic Therapy<br>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<br>* Robotic Therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Mean change from baseline at six weeks (19 sessions of robotic therapy). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wolf Motor Function Test (WMFT) | WMFT evaluates time performance and functional ability in 17 unimanual tasks. | 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). | Mean change from baseline at six weeks (19 sessions of robotic therapy). | 
| Patients safety | Adverse effects questionnaire applied in each session. | Adverse effects reported during 6 weeks treatment. | 
| Treatment adherence | Number of patients withdrawing from treatment without justification (drop outs). | Drop outs reported during 6 weeks treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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motor activity, robotic, stroke, rehabilitation, upper limb