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

Stroke Clinical Trial

— 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04992910
• Other study ID #: PI52021Rehab
• Status: Recruiting
• Phase: N/A
• Start date: February 14, 2022
• Est. completion date: September 1, 2022

Study information

• Verified date: February 2022
• Source: Maimónides Biomedical Research Institute of Córdoba
• Contact: Fernando Mayordomo Riera, MD
• Phone: 0034671596070
• Email: uicec[@]imibic.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Muscle Weakness
• Paresis
• Stroke
• Upper Extremity Paresis

Intervention

Device:
• Functional electrical stimulation through medical device
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.

Other:
• Standard therapy
Physical therapy applied to the subject. Duration: 80 min twice a week, for 6 weeks.

Locations

Country	Name	City	State
Spain	Hospital Universitario Reina Sofía	Córdoba

Sponsors (2)

Lead Sponsor	Collaborator
Maimónides Biomedical Research Institute of Córdoba	FESIA Technology

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from Baseline FMA scale at 6 weeks and 3 months
Secondary	Medical Research Council (MRC)	A standardized assessment to measure muscle strength; Score range 0-5 (minimum 0, maximum 5)	Baseline; 6 weeks; 3 months
Secondary	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.	Baseline; 6 weeks; 3 months
Secondary	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.	Baseline; 6 weeks; 3 months
Secondary	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).	Baseline; 6 weeks; 3 months
Secondary	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'.	6 weeks
Secondary	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.	6 weeks; 3 months
Secondary	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.	6 weeks
Secondary	Adverse events	Any untoward medical occurrence during the clinical trial	Through study completion, an average of 6 months