Stroke Clinical Trial
Official title:
"Evaluation Of ALBA® Device for Upper Extremity Motor Function In Adults (18-80 Years Old) With Hemiparesis Secondary To Acquired Brain Injury In Subacute And Chronic Phases"
Verified date | September 2023 |
Source | uMov |
Contact | Pamela A Salazar, Ing |
Phone | +56926444880 |
pamela[@]umov.cl | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
As part of the rehabilitation techniques, robotic equipment has been introduced for the rehabilitation of the upper extremity with promising results. In this context, the ALBA® devise for the training of the upper extremity is used in this project. This randomized controlled trial will compare a control group (n=16) with an experimental group (n=16) of adults with hemiparesis secondary to an acquired brain lesion. A convenience sample of inpatient will be selected from Los Coihues clinic after concealing the inclusion and exclusion criteria. All participants will perform 45 minutes of training, 5 days a week, for 4 weeks, 20 sessions total. The control group will receive 100% conventional treatment while the experimental group will receive 20 minutes of conventional treatment associated with 25 minutes of ALBA® training. Assessments will be taken before training (t1), at 4 weeks (t2), and at 3 months (t3).
Status | Recruiting |
Enrollment | 32 |
Est. completion date | July 11, 2024 |
Est. primary completion date | December 29, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: Patients of Los Coihues clinic Diagnosis of acquired brain injury. Cognitive capacity and language that allows understanding and following the therapist's instructions. Trunk control. Subacute and chronic stage (up to 2 years post injury). Upper extremity paresis able to perform movements with eliminated gravity (modified MRC 2). Exclusion Criteria: Cardiovascular instability Visual or acoustic limitations. Severe hypertonia (=3 Ashworth Scale). Upper extremity with passive joint limitation and/or traumatic injury. Neuropsychological alteration (global aphasia, severe attentional deficit, spatial perception alteration). Moderate to severe cognitive-behavioral alterations that do not allow the understanding of instructions. Severe alterations of consciousness. Deficit in cephalic control. Severe deficit in sedentary balance. |
Country | Name | City | State |
---|---|---|---|
Chile | Clínica Los Coihues | Santiago | Av. Laguna Sur 6561 Estación Central |
Lead Sponsor | Collaborator |
---|---|
uMov | Clínica los Coihues |
Chile,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes on the Fugl-Meyer test | The Fugl-Meyer Test is a widely used clinical assessment tool for measuring motor recovery in patients with brain damage, especially after a stroke.
The test consists of a series of motor activities designed to assess the patient's ability to perform specific movements, such as extending the arm, opening and closing the hand, and standing up from a chair. The movements are scored on a scale of 0 to 2, where 0 means the patient cannot perform the movement and 2 means the patient can perform the movement fully. |
Baseline (t1) and 30 days after (t2) | |
Secondary | ACER-R | The ACER-R test can be used in the evaluation of individuals who have suffered cognitive damage, such as a stroke or traumatic brain injury. In this case, the test is used to measure cognitive function and determine the degree of cognitive impairment that has occurred.
In terms of measurement units, the ACER-R uses a standardized scoring system based on the individual's age and the average population score. Scores are expressed in terms of raw scores, standard scores, and percentiles. These scores are used to compare the individual's cognitive capacity with that of the general population and to evaluate the degree of cognitive impairment that has occurred. The minimum possible score is 0 and the maximum is 143. |
Baseline (t1) | |
Secondary | MRC | The MRC (Medical Research Council) test is an assessment tool used to measure muscle strength in different muscle groups of the body. It involves the evaluator applying an opposing force to the muscle being evaluated while the individual performs a maximum contraction for several seconds. The strength is measured on a scale of 0 to 5, where 0 indicates a complete absence of muscle contraction and 5 indicates a complete normal contraction. | Baseline (t1) | |
Secondary | Ashworth | The Ashworth test is an assessment tool used to measure muscle tone in people with neurological diseases such as spasticity. It involves evaluating the resistance offered by a muscle to passive movement, i.e. when the evaluator moves the patient's limb in a specific direction without the patient actively participating.
During the test, the evaluator moves the patient's limb and evaluates the degree of resistance or muscle rigidity on a scale of 0 to 4, where 0 indicates the absence of resistance and 4 indicates severe muscle rigidity. The Ashworth test is used to assess the degree of spasticity in people with brain injuries, cerebral palsy, and other neurological diseases, and can be useful in guiding treatment and rehabilitation. |
Baseline (t1) | |
Secondary | FIM | The FIM (Functional Independence Measure) test is an evaluation tool used to measure functional independence in basic activities of daily living in individuals with physical, neurological, or cognitive disabilities.
The test consists of an evaluation of 18 items covering six areas of skills: self-care, sphincter control, transfers, locomotion, communication, and cognition. Each item is scored from 1 to 7, where 1 indicates total dependence and 7 indicates total independence. The total score is used to determine the individual's level of functional dependence and evaluate the effectiveness of interventions and rehabilitation programs. |
Baseline (t1) and 30 days after (t2) | |
Secondary | Test SF-36 | The SF-36 (Short Form-36) is a health survey questionnaire that measures the individual's overall health and quality of life. It consists of 36 questions that assess eight different health domains, including physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. The test is widely used in clinical and research settings to evaluate the impact of health interventions and to compare health outcomes between different populations.
The SF-36 questionnaire uses a scoring system that ranges from 0 to 100 for each of the eight health domains. A score of 100 indicates the highest level of health or quality of life, while a score of 0 indicates the lowest. Therefore, the total possible score is 800 (100 x 8 domains). |
Baseline (t1), 30 days after (t2) and at follow up (90 days) | |
Secondary | System Usability Scale | The System Usability Scale (SUS) is a questionnaire used to evaluate the usability and user-friendliness of a wide range of technological products, including software, websites, and hardware. The SUS consists of ten questions that assess the user's perception of various aspects of the product's usability, such as its ease of use, efficiency, and learnability. Each question is answered on a five-point scale, ranging from "strongly disagree" to "strongly agree." The SUS score ranges from 0 to 100, with a higher score indicating greater usability and user satisfaction. | Post intervention (30 days) |
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