Assessment of a Upper Limb Robotic Device in Stroke Patients

Not Applicable

• Conditions: Stroke
• Interventions: Device: Robotic Therapy

• Registration Number: NCT03469778
• Lead Sponsor: University of Sao Paulo General Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-12
• Study First Submitted: 2018-03-12
• Study First Submitted QC: 2018-03-12
• Last Update Submitted: 2018-03-12
• Study First Posted: 2018-03-19
• Last Update Posted: 2018-03-19
• Study Start: 2018-05-02
• Primary Completion: 2018-07
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Robotic Therapy	Robotic Therapy	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Centro de Pesquisa Clínica - Instituto de Medicina Física e Reabilitação; 🇧🇷 São Paulo, Brazil