Integrated Dual-task EMG Biofeedback Balance Training to Improve Balance in Individuals Living with Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Mini-Balance Evaluation Systems Test (Mini-BESTest)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-80 years with a formal diagnosis of MS.
- •Participants must be ambulatory and report problems with walking and/or balance.
- •Have stable disease with no relapses in the last 3 months.
- •Agreement to not introduce or change the dosage of pharmaceutical treatments during the study period. This includes intramuscular injections (e.g., Botox), intravenous, and orally administered drugs.
- •Agreement to maintain the frequency, duration and intensity of physical therapy or any alternate therapies (e.g., massage, osteopathic, chiropractic, etc.) for the duration of the trial.
排除标准
- •Unable to follow instructions due to cognitive deficit or language barrier
- •Presence of visual disorders that prevent meaningful interaction with the intervention interface.
- •Unable to maintain stable pharmaceutical treatment for the duration of the study.
- •Unable to maintain the frequency, duration and intensity of physical therapy or alternate therapies outside of the trial for the duration of the trial.
- •Received Botox treatment within 3 months of the onset of the study.
研究组 & 干预措施
Integrated Dual-task EMG Biofeedback Training (EMG-BF)
Participants will engage in EMG-BF for 30 minutes 3 times per week for 6 weeks for a total of 18 sessions. Our novel EMG Biofeedback training system can be adapted to a training objective by planning 3 to 5 movements and placing sensors over muscles that must be active when the user adheres to the correct movement form. For our training we use right or left torso shift with knee bend, and right or left hand opening, and place sensors over left and right vastus lateralis and left and right extensor digitorum superficialis muscles.
Each movement corresponds to a specific videogame command. To introduce cognitive challenge, we randomly shuffle the game command assigned to each movement at the beginning of every session. This will require the user to choose the appropriate movement to trigger the intended game input while suppressing incorrect movements. We use the puzzle game, Tetris, which requires spatial reasoning and planning under increasingly tight time constraints.
干预措施: Integrated Dual-task EMG Biofeedback Training (EMG-BF) (Device)
Traditional Balance Exercise Training (BAL-EX)
Participants will perform 7 balance exercises traditionally prescribed by physiotherapists. The first is a heel/toe square exercise where the trainee lifts their right toe and left heel, then their left toe and right heel, then both heels, then both toes. The 2nd exercise involves maintaining tandem stance while static, then moving the arms, then looking up and down, then looking left and right. The 3rd exercise is lateral stepping where the individual steps with one foot out to the side and then bring the foot back to the starting stance. The 4th exercise is a golfer's lift where the person slowly leans forward while extending one leg straight behind and touches the seat of a chair placed opposite. The 5th exercise is extended-duration single leg stands and exercises 6 and 7 are back and side leg raises, respectively. The exercise sequence will repeat until 30 minutes has expired. Sessions are repeated 3 times per week for 6 weeks, for 18 sessions.
干预措施: Traditional Balance Exercise Training (BAL-EX) (Behavioral)
结局指标
主要结局
Mini-Balance Evaluation Systems Test (Mini-BESTest)
时间窗: 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").
次要结局
- Short-Form 36 Health Survey (SF-36)(It will be measured at baseline, 6 weeks of training, and 3 months after the end of training (18 weeks from baseline))
- Limits of Stability (LoS)(It will be measured at baseline, 6 weeks of training, and 3 months after the end of training (18 weeks from baseline))
- Fall and Near-Fall Frequency(Participant will keep the fall diary from 2 weeks before the first training session to the end of the study, 20 weeks later.)
- Activities-specific Balance Confidence (ABC) scale(It will be measured at baseline, 6 weeks of training, and 3 months after the end of training (18 weeks from baseline))
- Timed 25ft Walk Test (T25WT)(It will be measured at baseline, 6 weeks of training, and 3 months after the end of training (18 weeks from baseline))
- 12-item Subjective Walking Scale (SWS-12)(It will be measured at baseline, 6 weeks of training, and 3 months after the end of training (18 weeks from baseline))
- Sway in Quiet Stance (QS)(It will be measured at baseline, 6 weeks of training, and 3 months after the end of training (18 weeks from baseline))
研究者
Aimee Nelson
Professor
McMaster University