Stroke, Upper Extremity Paresis
Conditions
Keywords
Stroke, Upper Extremity Paresis, Functional Electrical Stimulation
Brief summary
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. * 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.
Interventions
DEVICEFunctional 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.
OTHERStandard therapy
Physical therapy applied to the subject. Duration: 80 min twice a week, for 6 weeks.
Sponsors
Maimónides Biomedical Research Institute of Córdoba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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' |
| Adverse events | 6 weeks | Any untoward medical occurrence during the clinical trial |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| Fugl-Meyer Assessment (FMA) scale | 6 weeks | 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 |
Countries
Spain
Contacts
PRINCIPAL_INVESTIGATORFernando Mayordomo Riera, MD
Hospital General Universitario Reina Sofía de Murcia
Outcome results
None listed