Translingual Stimulation Combined With Physiotherapy to Improve Walking and Balance in Multiple Sclerosis: an RCT
试验速览
- 阶段
- 不适用
- 入组人数
- 52
- 试验地点
- 4
- 主要终点
- Dynamic Gait Index (DGI)
研究概览
简要总结
The overarching aim of this study is to examine if there is additional benefit to adding trans-lingual electrical stimulation to physiotherapy aimed at improving walking and balance in people with multiple sclerosis (MS).
详细描述
This is a two arm, participant-blinded, interventionist blinded, and research assessor-blinded RCT Participants with walking problems due to MS (Patient Determined Disease Steps PDDS 3-6) will be randomized 1:1 after baseline assessment stratified into 2 arms (lower walking disabilities PDDS 3+4, and higher walking disabilities PDDS 5+6) Following a 14 week balance and walking training intervention, participants will be instructed to continue to exercise independently according to the evidence-based Physical Activity Guidelines in MS for a subsequent 12 weeks. They will be reassessed at the end of that time (FOLLOW-UP).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •confirmed diagnosis of multiple sclerosis
- •gait deficit due to MS but still able to walk (EDSS less than 6.5, PDDS 3-6)
- •older than 18 and less than 70 years of age
- •agree to the study time commitment.
排除标准
- •currently attending physical rehabilitation for walking and/or balance training,
- •currently already functional community ambulators (gait speed>120cm/s)
- •contra-indications to the use of translingual electrical stimulation (active or suspected malignant tumor; recent bleeding or open wounds in mouth; women who are pregnant, or sensitivity to nickel, gold or copper)
结局指标
主要结局
Dynamic Gait Index (DGI)
时间窗: 27 weeks
This scale has 8 conditions that an individual walks in (e.g. normal, head turns, change in speed, pivot, stairs). Performance for each condition is scored on a scale of 0 to 3, with 3 indicating normal performance and 0 representing severe impairment. The best score on the DGI is 24, and a higher score means less walking impairment.
Timed 25 foot walk test (T25FWT)
时间窗: 27 weeks
The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time is calculated from the initiation of the instruction to start and ends when the patient has reached the 25-foot mark. The task is immediately administered again by having the patient walk back the same distance. Patients may use assistive devices when doing this task. Time to complete the T25FWT, and walking seed will be calculated. A lower time and faster walking speed indicates better walking performance
次要结局
- Multiple Sclerosis Impact Scale (MSIS-29)(27 weeks)
- Multiple sclerosis walking scale - 12 item (MSWS-12)(27 weeks)
- Fatigue Scale for Motor and Cognitive Functions(27 weeks)
- Short From 36 Health Survey Questionnaire (SF-36)(27 weeks)
研究者
Sarah Donkers
Principal Investigator, Assistant Professor
University of Saskatchewan