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Assessment of a Upper Limb Robotic Device in Stroke Patients

Primary Purpose

Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Robotic Therapy
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Stroke focused on measuring stroke, rehabilitation, upper limb, motor activity, robotic

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centro de Pesquisa Clínica - Instituto de Medicina Física e Reabilitação

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Robotic Therapy

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Wolf Motor Function Test (WMFT)
WMFT evaluates time performance and functional ability in 17 unimanual tasks.
Dynamometry - Grasp and Pinch
Instrument to measure palmar and lateral grip (strength in kgf).
Patients safety
Adverse effects questionnaire applied in each session.
Treatment adherence
Number of patients withdrawing from treatment without justification (drop outs).

Full Information

First Posted
March 12, 2018
Last Updated
March 12, 2018
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03469778
Brief Title
Assessment of a Upper Limb Robotic Device in Stroke Patients
Official Title
Assessment of a Upper Limb Robotic Device in Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 2, 2018 (Anticipated)
Primary Completion Date
July 2018 (Anticipated)
Study Completion Date
September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, rehabilitation, upper limb, motor activity, robotic

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Robotic Therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Robotic Therapy
Intervention Description
Robotic Therapy
Primary Outcome Measure Information:
Title
Fugl Meyer Assessment Upper Limb (FMA-UL)
Description
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.
Time Frame
Mean change from baseline at six weeks (19 sessions of robotic therapy).
Secondary Outcome Measure Information:
Title
Wolf Motor Function Test (WMFT)
Description
WMFT evaluates time performance and functional ability in 17 unimanual tasks.
Time Frame
Mean change from baseline at six weeks (19 sessions of robotic therapy).
Title
Dynamometry - Grasp and Pinch
Description
Instrument to measure palmar and lateral grip (strength in kgf).
Time Frame
Mean change from baseline at six weeks (19 sessions of robotic therapy).
Title
Patients safety
Description
Adverse effects questionnaire applied in each session.
Time Frame
Adverse effects reported during 6 weeks treatment.
Title
Treatment adherence
Description
Number of patients withdrawing from treatment without justification (drop outs).
Time Frame
Drop outs reported during 6 weeks treatment.
Other Pre-specified Outcome Measures:
Title
Clinical feasibility
Description
Time necessary to adjust the device; patients satisfaction questionnaire.
Time Frame
Reported during 6 weeks treatment, in each session.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Centro de Pesquisa Clínica - Instituto de Medicina Física e Reabilitação
City
São Paulo
ZIP/Postal Code
04116-040
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thais Tavares Terranova
Phone
5180-7800
Ext
7897
Email
thais.terranova@gmail.com
First Name & Middle Initial & Last Name & Degree
Artur César Aquino dos Santos
Phone
5180-7800
Ext
7897
Email
artur.santos@hc.fm.usp.br
First Name & Middle Initial & Last Name & Degree
Linamara Rizzo Battistella, PhD
First Name & Middle Initial & Last Name & Degree
Thais Tavares Terranova, Master of Science

12. IPD Sharing Statement

Plan to Share IPD
No

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Assessment of a Upper Limb Robotic Device in Stroke Patients

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