Biofeedback After Stroke

Official title

Use of Electromyographic Biofeedback in Upper Limb Rehabilitation After Stroke

Overview

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.

Interventions

• Device Electromyographic Biofeedback
  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",
• Device Sham (No Treatment)
  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 outcome measures

• Ashworth [Time frame: Ashworth will be applied at pre (baseline), through study completion, an average of 1 month.]

Secondary outcome measures (6)

• 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.]
• 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.]
• 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.]
• 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.]
• 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.]
• 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Brazil · 1 center

• Universidade Tecnológica Federal do Paraná — Curitiba

Publications

• 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
• 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
• 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
• 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 Stro PMID 27145936
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT07149129 · 84156424.6.0000.5547 · 84156424.6.0000.5547

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗