Biofeedback After Stroke
- Conditions
- Stroke
- Registration Number
- NCT07149129
- Lead Sponsor
- Universidade Federal do Paraná
- Brief Summary
Studies show that the use of electromyographic biofeedback combined with other therapies contributes to the reduction of upper limb spasticity after stroke. However, there is a lack of literature regarding the best protocols to use in clinical practice, as well as functional outcomes after this therapy. The objective of this research project will be to investigate the effect of electromyographic biofeedback on spasticity in individuals post-stroke in the sub-acute phase, and its outcomes regarding upper limb function and participation in activities of daily living. The study will be a randomized, triple-blind clinical trial in which the 45 participants will be divided into two groups: the experimental group will receive electromyographic biofeedback combined with functional training, and the control group will receive functional training with placebo biofeedback alone. The study hypothesis is that the use of electromyographic biofeedback contributes to improved functional outcomes and participation in activities of daily living in patients with upper limb spasticity resulting from stroke.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 45
- Patients with a clinical diagnosis of stroke (imaging tests and a medical report)
- Spasticity with an Ashworth score equal to or less than 3 in the upper limb
- 20-60 years old
- Other neurological impairments or trauma-orthopedic deformities in the upper limbs
- botulinum toxin/phenol injections within the previous 5 months
- medications that reduce muscle tone
- aphasia that prevents basic communication
- low vision or low visual acuity that prevents them from viewing the screen.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Ashworth Ashworth will be applied at pre (baseline), through study completion, an average of 1 month. The Ashworth scale will be used to measure the degree of spasticity of the upper limb muscles. The test will be performed manually and the score ranges from zero to four points. The higher the score, the greater the spasticity of the muscle tested.
- Secondary Outcome Measures
Name Time Method Upper limb function and participation - Motor Activity Log (MAL) The tests will be applied at pre (baseline), through study completion, an average of 1 month. The Motor Activity Log (MAL) measures how much the upper limb is used in daily activities. The average is directly proportional to the quantity and quality of upper limb use. In both scales, the minimally clinically relevant difference is 1.0 points if the paretic limb is not dominant or 1.1 points if the paretic limb is dominant.
Upper limb function and participation - Fugl-Meyer Assessment Scale The tests will be applied at pre (baseline), through study completion, an average of 1 month. Fugl-Meyer Assessment Scale will be used to measure range of motion, coordination, reflex activity, tactile sensitivity, and proprioception of the shoulder, elbow, wrist, and hand regions. The scale can be divided into two domains: motor (66 points) and sensory (12). The scoring can be from zero to three points, where: absent function is 0, 1 (one) is partial function, and 2 (two) is normal function. The minimally clinically important difference of this scale is 10% of the gross value, which is 6.6 points in the motor domain and 1.2 points in the sensory domain. Only scores for the affected limb will be considered.
Upper limb function and participation - The Functional Independence Measure (FIM) The tests will be applied at pre (baseline), through study completion, an average of 1 month. The Functional Independence Measure (FIM) will be used to potentially classify the level of dependence of the subject as: complete (18 to 45 points), moderate independence (46 to 99), and full independence (100 to 126). The lower the subject's score, the more dependent they are. The minimally clinically important difference for this evaluation is 22 points.
Upper limb function and participation - Modified Ashworth scale The tests will be applied at pre (baseline), through study completion, an average of 1 month. The Modified Ashworth scale will be used to measure the degree of spasticity in the upper limb musculature. The score ranges from zero to four points. The higher the score, the greater the spasticity of the tested muscle.
Upper limb function and participation - Box and Block Test (BBT) The tests will be applied at pre (baseline), through study completion, an average of 1 month. In the Box and Block Test (BBT) the patient will be instructed to move as many blocks as possible from one side of the box to the other in 60 seconds, placing only one block at a time. The score obtained is equal to the number of blocks transported in one partition in one minute. It is assessed that the more blocks transported within the established time, the better the manual dexterity of the patient.
Upper limb function and participation - Jebsen Manual Function Test (JTT) The tests will be applied at pre (baseline), through study completion, an average of 1 month. Jebsen Manual Function Test (JTT) will require to the participant to perform six tasks: turning cards and small common objects, simulating feeding, stacking chips, moving large light and heavy objects. Each task will be timed, and the participant will have a maximum of 120 seconds to complete each task.
Trial Locations
- Locations (1)
Universidade Tecnológica Federal do Paraná
🇧🇷Curitiba, Paraná, Brazil
Universidade Tecnológica Federal do Paraná🇧🇷Curitiba, Paraná, Brazil