Monitoring Intensity During Balance Training in Persons With Multiple Sclerosis (BALANCE-MS)
2026年9月14日 更新者：Jens Bansi、Klinik Valens
Monitoring Intensity During Balance Training in Persons With Multiple Sclerosis - a Randomized Feasibility Study
Balance training is recommended to improve gait stability and mobility.
However, there are currently no clearly defined methods for controlling the intensity (challenge) of balance training.
This research project aims to determine whether balance training for individuals with multiple sclerosis (MS), individually tailored to the level of difficulty and exertion, is feasible and possible within an inpatient rehabilitation setting.
Participants will be randomly assigned to one of two groups: either they will complete group training focusing on strength, endurance, and balance in addition to their regular therapy program, or they will receive individually tailored balance training.
Both groups will undergo an initial assessment followed by seven training sessions, each lasting approximately 45-60 minutes.
Before discharge, the initial assessments will be repeated.
These assessments include completing questionnaires, performing gait tests, balance tests, and a short cognitive test.
Interviews will also be conducted with patients and therapists.
These are intended to help better assess the feasibility of the training and to gain more insight into the experiences with the training.
研究概览
研究类型
介入性
注册 (估计的)
60
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Jens Bansi, PhD
- 电话号码：+41 58 511 13 02
- 邮箱：jens.bansi@kliniken-valens.ch
研究联系人备份
- 姓名：Isa Slotboom, MSc
- 电话号码：+0585111375
- 邮箱：isa.slotboom@kliniken-valens.ch
学习地点
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Canton of St. Gallen
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Valens、Canton of St. Gallen、瑞士、7317
- 招聘中
- Rehabilitation Centre Valens
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首席研究员：
- Jens Bansi, PhD
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接触：
- Jens Bansi, PhD
- 电话号码：+41 58 511 13 02
- 邮箱：jens.bansi@kliniken-valens.ch
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接触：
- Isa Slotboom, MSc
- 电话号码：+41 58 511 13 02
- 邮箱：isa.slotboom@kliniken-valens.ch
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副研究员：
- Isa Slotboom, MSc
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副研究员：
- Laura Engler, MSc
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Patients with a definite MS diagnosis according to 2024 revised McDonald criteria;
- Hold an Expanded disability status (EDSS) between 2.0-6.5;
- An inpatient stay of at least three weeks at the ;
- Aged 18 years and older;
- Have sufficient knowledge of the German language (spoken and written).
Exclusion Criteria:
- Cognitive impairment indicated by a score of <21 on the Montreal Cognitive Assessment (MoCA);
- Severe osteoporosis;
- Fractures and/or other surgical interventions;
- Presence of any other condition that would substantially influence balance;
- Alcoholism;
- Participation in another study;
- Pregnancy.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Balance training
The balance training is performed three times per week over a period of three weeks with sessions lasting 45-60 minutes.
The intervention is designed to meet the individual needs of pwMS and allows for challenging tasks, while guaranteeing safety by a harnass.
During the first training session the appropriate exercise levels that target the adequate intensity are determined (baseline value).
Moderate to high-intensive BT in this study is defined as a score of 7-9 points on the rate of perceived stability (RPS) scale and to fulfill the moderate to high-intensive characteristics on the therapists' scale.
The intensity of each exercise (level of challenge during the exercise) is monitored and documented for both the therapists and pwMS.
According to this feedback, progression is performed by systematically by in- or decreasing difficulty of the exercises.
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The balance training is performed three times per week over a period of three weeks with sessions lasting 45-60 minutes.
The intervention is designed to meet the individual needs of pwMS and allows for challenging tasks, while guaranteeing safety by a harnass.
During the first training session the appropriate exercise levels that target the adequate intensity are determined (baseline value).
Moderate to high-intensive BT in this study is defined as a score of 7-9 points on the rate of perceived stability (RPS) scale and to fulfill the moderate to high-intensive characteristics on the therapists' scale.
The intensity of each exercise (level of challenge during the exercise) is monitored and documented for both the therapists and pwMS.
According to this feedback, progression is performed by systematically by in- or decreasing difficulty of the exercises.
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有源比较器：Sporttherapy
The control group performs a standardized group training session (usual care, UC) that consists of strength, endurance, coordination, balance and mobility exercises.
This training is part of standard care at the Rehabilitation Clinic Valens and is therefore not personalized for each participant.
The training is performed three times per week over a period of three weeks with sessions lasting 45-60 minutes.
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The control group performs a standardized group training session (usual care, UC) that consists of strength, endurance, coordination, balance and mobility exercises.
This training is part of standard care at the Rehabilitation Clinic Valens and is therefore not personalized for each participant.
The training is performed three times per week over a period of three weeks with sessions lasting 45-60 minutes.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Balance capacity
大体时间：From enrollment to the end of treatment at 3 weeks.
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Balance capacity measured by the Mini Balance Evaluation system Test (Mini-Best).
Measured with a score from 0-28, a higher score indicates a better balance capacity.
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From enrollment to the end of treatment at 3 weeks.
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Cognitive processing speed
大体时间：From enrollment to the end of treatment at 3 weeks.
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Cognitive processing speed is measured with the Symbol Digit Modalities Test (SDMT).
Participants receive a sheet with a key of nine numbers (1-9) and symbols shown in pairs.
In boxes below only the symbols are shown, and the participants must report the correct corresponding number.
The number of correct answers made within 90 seconds is assessed.
The oral form of the SDMT is used due to its non-sensitivity to motor disabilities of the upper extremities.
Higher scores indicate higher cognitive processing speed.
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From enrollment to the end of treatment at 3 weeks.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Mobility
大体时间：From enrollment to the end of treatment at 3 weeks.
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Mobility measured by the Timed Up and Go Test (TUG).
Measurement in seconds, a lower time indicates a better functional mobility.
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From enrollment to the end of treatment at 3 weeks.
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Complex walking ability
大体时间：From enrollment to the end of treatment at 3 weeks.
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Complex walking ability measured by the Six Spot Step Test (SSST).
Measurement in seconds for all trials and for the trials with the dominant and non-dominant leg, a lower time indicates a better complex walking ability.
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From enrollment to the end of treatment at 3 weeks.
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Fatigue
大体时间：From enrollment to the end of treatment at 3 weeks.
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Fatigue measured with the Fatigue Scale for Motor and Cognitive Function (FSMC) Questionnaire.
A total score [20-100] and a motor and cognitive subscores [each 10-50] are calculated, a higher score indicates a higher fatigue.
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From enrollment to the end of treatment at 3 weeks.
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Walking endurance
大体时间：From enrollment to the end of treatment at 3 weeks.
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Walking endurance measured with the 6 Minute Walking Test.
Within this test the total distance [m], the 2 minute distance [m], and the steps [Number] and time [s] needed for 10 meters are measured.
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From enrollment to the end of treatment at 3 weeks.
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Fear of falling
大体时间：From enrollment to the end of treatment at 3 weeks
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Fear of falling is measured with the Falls Efficacy Scale-International (FES-I).
Participants must answer 16 different questions regarding their fear of falling during activities of daily life.
For each item the level of fear is assessed on a 4-point scale (from 1="not at all" to 4="very").
Scores range from 16-64, with higher scores indicating a higher fair of falling during daily activities.
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From enrollment to the end of treatment at 3 weeks
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Health related quality of life
大体时间：From enrollment to the end of treatment at 3 weeks
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Health related quality of life is measured with the Patient Reported Outcomes Measurement Information System-10 (PROMIS-10).
They score each item on a 5-point scale and rate their pain from 0 to 10.
The score is summarized to a mental and a physical health score, each from 0-20.
With low scores indicating poor perceived health related quality of life.
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From enrollment to the end of treatment at 3 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Jens Bansi, PhD、Klinik Valens
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年5月6日
初级完成 (估计的)
2027年12月1日
研究完成 (估计的)
2027年12月1日
研究注册日期
首次提交
2026年9月1日
首先提交符合 QC 标准的
2026年9月1日
首次发布 (实际的)
2026年9月4日
研究记录更新
最后更新发布 (实际的)
2026年9月17日
上次提交的符合 QC 标准的更新
2026年9月14日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.