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Study of the Effectiveness of "Fesia Grasp": Functional Electrical Stimulation Device for Upper Limb Rehabilitation After Stroke (PI52021Rehab)

Primary Purpose

Stroke, Upper Extremity Paresis

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Functional electrical stimulation through medical device
Standard therapy
Sponsored by
Maimónides Biomedical Research Institute of Córdoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Upper Extremity Paresis, Functional Electrical Stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years old or older subjects with hemiparesis in the upper limb after stroke, which have been referred to the Rehabilitation Unit of the Reina University Hospital.
  • Unilateral paresis
  • Cognitive ability to assimilate and actively participate in the protocol of evaluation and treatment

Exclusion Criteria:

  • Very severe proximal spasticity: Ashworth > 3.
  • Psychiatric illness (including post-stroke depression).
  • Cognitive impairment.
  • Inability to provide informed consent.
  • Other severe medical problems.
  • Severe hemi-spatial neglect or anosognosia involving the affected arm.
  • Pacemakers
  • Pregnant women.
  • Skin ulcers.
  • Peripheral neuropathies.
  • Edema of the affected forearm and / or hand.
  • Severe pain.

Sites / Locations

  • Hospital Universitario Reina SofíaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Functional Electrical Stimulation

Standard Therapy

Arm Description

Outcomes

Primary Outcome Measures

Fugl-Meyer Assessment (FMA) scale
It is an index to assess the sensorimotor impairment in individuals who have had stroke. The Fugl-Meyer Assessment scale is an ordinal scale that has 3 points for each item. A zero score is given for the item if the subject cannot do the task. A score of 1 is given when the task is performed partially and a score of 2 is given when the task is performed fully. The maximun score is 66 points

Secondary Outcome Measures

Medical Research Council (MRC)
A standardized assessment to measure muscle strength; Score range 0-5 (minimum 0, maximum 5)
Modified Ashworth Scale (MAS)
This scale measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity. It is single-item measures ranging from 0 to 4, where 0 indicates no increase in muscle tone and 4 indicates that the affected part is rigid in flexion or extension.
Box & Blocks Test
It assesses unilateral gross manual dexterity. Individuals are seated at a table, facing a rectangular box that is divided into two square compartments of equal dimension by means of a partition. One hundred and fifty, 2.5 cm, colored, wooden cubes or blocks are placed in one compartment or the other. The test is scored by counting the number of blocks carried over the partition from one compartment to the other during the one-minute trial period.
Motor Activity Log (MAL)
Semi-structured interview to assess arm function. Individuals are asked to rate Quality of Movement and Amount of Movement during 30 daily functional tasks. Target tasks include object manipulation (e.g. pen, fork, comb, and cup) as well as the use of the arm during gross motor activities (e.g. transferring to a car, steadying oneself during standing, pulling a chair into a table while sitting).
Intrinsic Motivation Inventory (IMI)
This scale is a multidimensional scale intended to assess participants subjective experience with the device (interest/enjoyment, perceived competence, effort, value/usefulness, felt pressure and tension, and perceived choice while performing a given activity). Consist of 20 item questionnaire with answers from 1 'strongly agree' to 7 'strongly disagree'.
Euroqol-5d
Spanish version of the EuroQol-5D questionnaire (EQ-5D). It is a generic ABVD measurement instrument. The individual himself assesses his state of health, first in severity levels by five dimensions: mobility, personal care, daily activities, pain / discomfort and anxiety / depression.
Usability questionnaire specifically designed for this study
It consists of a 5 item questionnaire with five response options (Likert sacle); from Strongly agree to Strongly disagree. To evaluate the satisfaction of patients with the system and the therapy.
Adverse events
Any untoward medical occurrence during the clinical trial

Full Information

First Posted
July 16, 2021
Last Updated
February 17, 2022
Sponsor
Maimónides Biomedical Research Institute of Córdoba
Collaborators
FESIA Technology
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1. Study Identification

Unique Protocol Identification Number
NCT04992910
Brief Title
Study of the Effectiveness of "Fesia Grasp": Functional Electrical Stimulation Device for Upper Limb Rehabilitation After Stroke
Acronym
PI52021Rehab
Official Title
Study of the Effectiveness of Functional Electrical Stimulation Through the "Fesia Grasp" Device in the Rehabilitative Treatment of Patients With Affected Upper Limbs After a Stroke.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 14, 2022 (Actual)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maimónides Biomedical Research Institute of Córdoba
Collaborators
FESIA Technology

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effectiveness of Fesia Grasp, a Functional Electrical Stimulation device for the rehabilitation of upper limb in post-stroke patients. Fesia Grasp rehabilitation will be compared with usual care rehabilitation of upper limb. Experimental group: patients will receive Fesia Grasp therapy (intensive, repetitive and functional exercises assisted by functional electrical stimulation) Control group - patients will receive standard care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Upper Extremity Paresis
Keywords
Stroke, Upper Extremity Paresis, Functional Electrical Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Functional Electrical Stimulation
Arm Type
Experimental
Arm Title
Standard Therapy
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Functional electrical stimulation through medical device
Intervention Description
The patient will receive a therapy with functional electrical stimulation. For this, a device called "Fesia Grasp" will be used. Duration: 80 min twice a week, for 6 weeks.
Intervention Type
Other
Intervention Name(s)
Standard therapy
Intervention Description
Physical therapy applied to the subject. Duration: 80 min twice a week, for 6 weeks.
Primary Outcome Measure Information:
Title
Fugl-Meyer Assessment (FMA) scale
Description
It is an index to assess the sensorimotor impairment in individuals who have had stroke. The Fugl-Meyer Assessment scale is an ordinal scale that has 3 points for each item. A zero score is given for the item if the subject cannot do the task. A score of 1 is given when the task is performed partially and a score of 2 is given when the task is performed fully. The maximun score is 66 points
Time Frame
Change from Baseline FMA scale at 6 weeks and 3 months
Secondary Outcome Measure Information:
Title
Medical Research Council (MRC)
Description
A standardized assessment to measure muscle strength; Score range 0-5 (minimum 0, maximum 5)
Time Frame
Baseline; 6 weeks; 3 months
Title
Modified Ashworth Scale (MAS)
Description
This scale measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity. It is single-item measures ranging from 0 to 4, where 0 indicates no increase in muscle tone and 4 indicates that the affected part is rigid in flexion or extension.
Time Frame
Baseline; 6 weeks; 3 months
Title
Box & Blocks Test
Description
It assesses unilateral gross manual dexterity. Individuals are seated at a table, facing a rectangular box that is divided into two square compartments of equal dimension by means of a partition. One hundred and fifty, 2.5 cm, colored, wooden cubes or blocks are placed in one compartment or the other. The test is scored by counting the number of blocks carried over the partition from one compartment to the other during the one-minute trial period.
Time Frame
Baseline; 6 weeks; 3 months
Title
Motor Activity Log (MAL)
Description
Semi-structured interview to assess arm function. Individuals are asked to rate Quality of Movement and Amount of Movement during 30 daily functional tasks. Target tasks include object manipulation (e.g. pen, fork, comb, and cup) as well as the use of the arm during gross motor activities (e.g. transferring to a car, steadying oneself during standing, pulling a chair into a table while sitting).
Time Frame
Baseline; 6 weeks; 3 months
Title
Intrinsic Motivation Inventory (IMI)
Description
This scale is a multidimensional scale intended to assess participants subjective experience with the device (interest/enjoyment, perceived competence, effort, value/usefulness, felt pressure and tension, and perceived choice while performing a given activity). Consist of 20 item questionnaire with answers from 1 'strongly agree' to 7 'strongly disagree'.
Time Frame
6 weeks
Title
Euroqol-5d
Description
Spanish version of the EuroQol-5D questionnaire (EQ-5D). It is a generic ABVD measurement instrument. The individual himself assesses his state of health, first in severity levels by five dimensions: mobility, personal care, daily activities, pain / discomfort and anxiety / depression.
Time Frame
6 weeks; 3 months
Title
Usability questionnaire specifically designed for this study
Description
It consists of a 5 item questionnaire with five response options (Likert sacle); from Strongly agree to Strongly disagree. To evaluate the satisfaction of patients with the system and the therapy.
Time Frame
6 weeks
Title
Adverse events
Description
Any untoward medical occurrence during the clinical trial
Time Frame
Through study completion, an average of 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years old or older subjects with hemiparesis in the upper limb after stroke, which have been referred to the Rehabilitation Unit of the Reina University Hospital. Unilateral paresis Cognitive ability to assimilate and actively participate in the protocol of evaluation and treatment Exclusion Criteria: Very severe proximal spasticity: Ashworth > 3. Psychiatric illness (including post-stroke depression). Cognitive impairment. Inability to provide informed consent. Other severe medical problems. Severe hemi-spatial neglect or anosognosia involving the affected arm. Pacemakers Pregnant women. Skin ulcers. Peripheral neuropathies. Edema of the affected forearm and / or hand. Severe pain.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fernando Mayordomo Riera, MD
Phone
0034671596070
Email
uicec@imibic.org
First Name & Middle Initial & Last Name or Official Title & Degree
Silvia Guillén Climent
Email
silvia.guillen@imibic.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando Mayordomo Riera, MD
Organizational Affiliation
Hospital Universitario Reina Sofía
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Reina Sofía
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernando Mayordomo Riera, MD
Phone
0034671596070
Email
uicec@imibic.org
First Name & Middle Initial & Last Name & Degree
Silvia Guillén Climent
Email
silvia.guillen@imibic.org
First Name & Middle Initial & Last Name & Degree
Fernando Mayordomo Riera, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The results will be available for other investigators.
IPD Sharing Time Frame
Once the trial is ended and the result are published in a paper.
IPD Sharing Access Criteria
Upon request to silvia.guillen@imibic.org

Learn more about this trial

Study of the Effectiveness of "Fesia Grasp": Functional Electrical Stimulation Device for Upper Limb Rehabilitation After Stroke

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