Assessment of a Upper Limb Robotic Device in Stroke Patients

NCT03469778 | Unknown DMC

• 1 other identifier: 71611217.5.0000.0068
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

stroke; rehabilitation; upper limb; motor activity; robotic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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.

Other Outcomes (1)

• Clinical feasibility

  Reported during 6 weeks treatment, in each session.

Study Arms (1)

Robotic Therapy

EXPERIMENTAL

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

Interventions

Robotic Therapy DEVICE

Robotic Therapy

Robotic Therapy

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Centro de Pesquisa Clínica - Instituto de Medicina Física e Reabilitação

São Paulo, 04116-040, Brazil

Location

MeSH Terms

Conditions

Stroke; Motor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: March 19, 2018
• Study Start: May 2, 2018
• Primary Completion: July 1, 2018
• Study Completion: September 1, 2018
• Last Updated: March 19, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)