Assessment of a Upper Limb Robotic Device in Stroke Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- University of Sao Paulo General Hospital
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Fugl Meyer Assessment Upper Limb (FMA-UL)
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Wolf Motor Function Test (WMFT)(Mean change from baseline at six weeks (19 sessions of robotic therapy).)
- Dynamometry - Grasp and Pinch(Mean change from baseline at six weeks (19 sessions of robotic therapy).)
- Patients safety(Adverse effects reported during 6 weeks treatment.)
- Treatment adherence(Drop outs reported during 6 weeks treatment.)