Assessment of a Upper Limb Robotic Device in Stroke Patients

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.

Study Overview

• Status: Unknown
• Conditions: Stroke
• Intervention / Treatment: Device: Robotic Therapy

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 04116-040
    • Centro de Pesquisa Clínica - Instituto de Medicina Física e Reabilitação

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Device: Robotic Therapy; Robotic Therapy

What is the study measuring?

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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical feasibility	Time necessary to adjust the device; patients satisfaction questionnaire.	Reported during 6 weeks treatment, in each session.

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): May 2, 2018
• Primary Completion (Anticipated): July 1, 2018
• Study Completion (Anticipated): September 1, 2018

Study Registration Dates

• First Submitted: March 12, 2018
• First Submitted That Met QC Criteria: March 12, 2018
• First Posted (Actual): March 19, 2018

Study Record Updates

• Last Update Posted (Actual): March 19, 2018
• Last Update Submitted That Met QC Criteria: March 12, 2018
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: stroke; rehabilitation; upper limb; robotic; motor activity
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 71611217.5.0000.0068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No