Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the feasibility, usability, and safety of multi-field FES-assisted therapy for hand rehabilitation in individuals with subacute stroke. A secondary, exploratory objective is to estimate preliminary effect sizes for distal upper-limb motor outcomes to inform the design of future adequately powered trials.
Fesia Grasp rehabilitation will be compared with usual care rehabilitation of upper limb.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Functional Electrical Stimulation | Experimental |
| |
| Standard Therapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Functional electrical stimulation through medical device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Adverse events | Any untoward medical occurrence during the clinical trial | 6 weeks |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Fernando Mayordomo Riera, MD | Hospital General Universitario Reina SofÃa de Murcia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Reina SofÃa | Córdoba | Córdoba | 14004 | Spain |
The results will be available for other investigators.
Once the trial is ended and the result are published in a paper.
Upon request to silvia.guillen@imibic.org
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Standard therapy | Other | Physical therapy applied to the subject. Duration: 80 min twice a week, for 6 weeks. |
|
| 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 |
| 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 |
| 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 | 6 weeks |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D010291 | Paresis |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided