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Enrolling by Invitation

NCT Number: NCT07149129

Biofeedback After Stroke

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Tecnológica Federal do Paraná

Curitiba, Paraná, 55, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Electromyographic Biofeedback

Device

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.

Sham (No Treatment)

Device

The intervention with the placebo 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.

Primary outcomes

  1. Ashworth

    Time frame: 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 outcomes

  1. Upper limb function and participation - The Functional Independence Measure (FIM)

    Time frame: 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.

  2. Upper limb function and participation - Modified Ashworth scale

    Time frame: 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.

  3. Upper limb function and participation - Motor Activity Log (MAL)

    Time frame: 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.

  4. Upper limb function and participation - Box and Block Test (BBT)

    Time frame: 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.

  5. Upper limb function and participation - Jebsen Manual Function Test (JTT)

    Time frame: 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.

  6. Upper limb function and participation - Fugl-Meyer Assessment Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Universidade Federal do Paraná

Other

Collaborators

  • UTFPR

Registry information

Official study title

Use of Electromyographic Biofeedback in Upper Limb Rehabilitation After Stroke

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Aug 29, 2025
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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