Biofeedback After Stroke

NCT07149129 | Enrolling By Invitation DMC

• 1 other identifier: 84156424.6.0000.5547
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

muscle spasticity; stroke; biofeedback; electromyography

Outcome Measures

Primary Outcomes (1)

• Ashworth

  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.

  Ashworth will be applied at pre (baseline), through study completion, an average of 1 month.

Secondary Outcomes (6)

• 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.

• Upper limb function and participation - Modified Ashworth scale

  The tests will be applied at pre (baseline), through study completion, an average of 1 month.

• 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.

• 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.

• 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.

Study Arms (2)

EMG Biofeedback - Intervention

PLACEBO COMPARATOR

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.

Device: Electromyographic Biofeedback

EMG Biofeedback - Sham

SHAM COMPARATOR

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.

Device: Sham (No Treatment)

Interventions

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.

EMG Biofeedback - Intervention

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.

EMG Biofeedback - Sham

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• years old

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal do Paraná: lead
• UTFPR: collaborator

Study Sites (1)

Universidade Tecnológica Federal do Paraná

Curitiba, Paraná, 55, Brazil

Location

Related Publications (8)

• Liu M, Xu L, Li H, Chen S, Chen B. Morphological and Functional Changes of the Tibialis Anterior Muscle After Combined Mirror Visual Feedback and Electromyographic Biofeedback in Poststroke Patients: A Randomized Trial. Am J Phys Med Rehabil. 2021 Aug 1;100(8):766-773. doi: 10.1097/PHM.0000000000001628.

  PMID: 33105154 BACKGROUND

• Nordio S, Arcara G, Berta G, Dellai A, Brisotto C, Koch I, Cazzador D, Aspidistria M, Ventura L, Turolla A, D'Imperio D, Battel I. Biofeedback as an Adjunctive Treatment for Post-stroke Dysphagia: A Pilot-Randomized Controlled Trial. Dysphagia. 2022 Oct;37(5):1207-1216. doi: 10.1007/s00455-021-10385-2. Epub 2021 Nov 12.

  PMID: 34767083 BACKGROUND

• Hou M, Zhao Y, Zhao L, Yuan X, Liu Z, Li H. Efficacy of game training combined with surface electromyography biofeedback on post-stroke dysphagia. Geriatr Nurs. 2024 Jan-Feb;55:255-262. doi: 10.1016/j.gerinurse.2023.11.019. Epub 2023 Dec 12.

  PMID: 38091711 BACKGROUND

• Winstein CJ, Stein J, Arena R, Bates B, Cherney LR, Cramer SC, Deruyter F, Eng JJ, Fisher B, Harvey RL, Lang CE, MacKay-Lyons M, Ottenbacher KJ, Pugh S, Reeves MJ, Richards LG, Stiers W, Zorowitz RD; American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on Quality of Care and Outcomes Research. Guidelines for Adult Stroke Rehabilitation and Recovery: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2016 Jun;47(6):e98-e169. doi: 10.1161/STR.0000000000000098. Epub 2016 May 4.

  PMID: 27145936 BACKGROUND

• Feng S, Tang M, Huang G, Wang J, He S, Liu D, Gu L. EMG biofeedback combined with rehabilitation training may be the best physical therapy for improving upper limb motor function and relieving pain in patients with the post-stroke shoulder-hand syndrome: A Bayesian network meta-analysis. Front Neurol. 2023 Jan 10;13:1056156. doi: 10.3389/fneur.2022.1056156. eCollection 2022.

  PMID: 36703623 BACKGROUND

• Woodford H, Price C. EMG biofeedback for the recovery of motor function after stroke. Cochrane Database Syst Rev. 2007 Apr 18;2007(2):CD004585. doi: 10.1002/14651858.CD004585.pub2.

  PMID: 17443550 BACKGROUND

• Elshafey MA, Abd-Elaziem A, Gouda RE. Functional stretching exercise submitted for spastic diplegic children: a randomized control study. Rehabil Res Pract. 2014;2014:814279. doi: 10.1155/2014/814279. Epub 2014 Jul 20.

  PMID: 25143834 BACKGROUND

• Koh SH, Park HH. Neurogenesis in Stroke Recovery. Transl Stroke Res. 2017 Feb;8(1):3-13. doi: 10.1007/s12975-016-0460-z. Epub 2016 Mar 18.

  PMID: 26987852 BACKGROUND

MeSH Terms

Conditions

Stroke; Muscle Spasticity

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD.

Model Details: Sham group

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 29, 2025
• Study Start: August 1, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)