Biofeedback After Stroke

Universidade Federal do Paraná

Status: Invitation-only

Conditions: Stroke

Treatments: Device: Electromyographic Biofeedback; Device: Sham (No Treatment)

Study type: Interventional

Funder types: Other

Identifiers

NCT07149129

84156424.6.0000.5547 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 2 patient groups, including a placebo group

EMG Biofeedback - Intervention

Placebo Comparator group

Description:

This intervention phase will last 30 minutes of training, during which the participant will be encouraged to actively and voluntarily relax their spastic muscles and will receive visual feedback through the software when this occurs. Two modes will be used in the software: the first, called "Recovery", which consists of a game in which the participant is encouraged to contract and relax their muscles in order to guide a rocket in a specific direction to earn points. The second, called "Maestro", in which the participant's objective is to keep the rocket below the specified line while maintaining their muscles relaxed. The participant will perform each mode for 15 minutes, totaling the proposed 30 minutes. There may be a break between each mode if the participant experiences fatigue. Afterward, they will receive standard occupational therapy.

Treatment:

Device: Electromyographic Biofeedback

EMG Biofeedback - Sham

Sham Comparator group

Description:

The intervention with the placebo (sham) group will have an identical structure to that of the intervention group, but during the biofeedback phase, the software screen will be a simulation, not corresponding to the patient's muscle activity. The patient will receive occupational therapy as usual, in a manner identical to that of the intervention group after the placebo biofeedback therapy.

Treatment:

Device: Sham (No Treatment)