Study of the Effectiveness of "Fesia Grasp": Functional Electrical Stimulation Device for Upper Limb Rehabilitation After Stroke
- Conditions
- StrokeUpper Extremity Paresis
- Interventions
- Other: Standard therapyDevice: Functional electrical stimulation through medical device
- Registration Number
- NCT04992910
- Lead Sponsor
- Maimónides Biomedical Research Institute of Córdoba
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard Therapy Standard therapy - Functional Electrical Stimulation Functional electrical stimulation through medical device -
- Primary Outcome Measures
Name Time Method Fugl-Meyer Assessment (FMA) scale Change from Baseline FMA scale at 6 weeks and 3 months 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
Name Time Method Medical Research Council (MRC) Baseline; 6 weeks; 3 months A standardized assessment to measure muscle strength; Score range 0-5 (minimum 0, maximum 5)
Modified Ashworth Scale (MAS) Baseline; 6 weeks; 3 months 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 Baseline; 6 weeks; 3 months 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) Baseline; 6 weeks; 3 months 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) 6 weeks 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 6 weeks; 3 months 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 6 weeks 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 Through study completion, an average of 6 months Any untoward medical occurrence during the clinical trial
Trial Locations
- Locations (1)
Hospital Universitario Reina Sofía
🇪🇸Córdoba, Spain