EMG Biofeedback Training to Improve Balance in Individuals with Multiple Sclerosis

Condition(s) studied

Investigational drug(s) / intervention(s)

Integrated Dual-task EMG Biofeedback Training (EMG-BF): The intervention is an exercise training that is facilitated by feedback derived from electrical muscle activity measured through electromyography (EMG). An EMG Biofeedback software uses a machine learning algorithm to identify the desired movements and reinforce them by displaying feedback on a computer monitor in the form of videogame control. The EMG acquisition hardware must have at least 4 sensor channels and a sampling rate of \>1KHz. Other than these specifications, any generic EMG amplifier can be used. The effect of the "device" is therefore primarily defined by the software. An in-depth description of the software and hardware systems is published in the cites study, "An EMG-Based Biofeedback System for Tailored Interventions Involving Distributed Muscles". In this trail is the Explore+ ExG amplifier which is sold by Mentalab.

Traditional Balance Exercise Training (BAL-EX): This intervention is a time-matched active comparator for the EMG-BF intervention. A sequence of seven traditional, balance exercises, taking 1-3 minutes each, is repeated for a total of 30 minutes on each of 18 sessions in the 6-week intervention period. The exercises are ones that challenge the coordination and strength of postural muscles in the presence of various vestibular stimuli. The specific exercises are described in the Arm description.

Study summary

The goal of this clinical trial is to test the impact of a novel dual-task EMG Biofeedback training method for improving balance in individuals living with multiple sclerosis. The main question\[s\] it aims to answer are:

* Does dual-task EMG biofeedback training deliver lasting balance benefits up to 3 months following the intervention?
* Are the benefits greater than those for participation in traditional balance training exercises?
* Do the benefits vary with the severity of disability?

Participants will receive either EMG Biofeedback (EMG-BF) training or traditional balance exercise (BAL-EX) training. Both treatments involve three 30-minute sessions of the training every week for 6 weeks (18 sessions). During the sessions, participants in the EMG-BF treatment group will perform targeted exercises using feedback from adhesive (sticker) sensors on their arms and legs. Participants in the BAL-EX treatment group will following an instructor through balance training movements that are traditionally prescribed by physiotherapists to improve balance. Measurements will be taken at the beginning of the study, after six weeks of training, and three months after the end of training.

Researchers will compare the groups to see if balance and related outcomes are improved more by 6-weeks of EMG-BF training than BAL-EX.

Eligibility

Primary outcome measure(s)

• Mini-Balance Evaluation Systems Test (Mini-BESTest) — It will be measured at baseline, 6 weeks of training, and 3 months after the end of training (18 weeks from baseline)
  A sensitive, reliable, and valid 14-item scale that assesses dynamic balance. It includes components evaluating anticipatory postural adjustments, responses to perturbation, sensory orientation, and dynamic stability during gait. The total score ranges from 0 ("no balance") to 28 ("complete balance").

Trial sites (1)

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