Monitoring Intensity During Balance Training in Persons With Multiple Sclerosis (BALANCE-MS)
2026년 9월 14일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (추정된)
60
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Jens Bansi, PhD
- 전화번호: +41 58 511 13 02
- 이메일: jens.bansi@kliniken-valens.ch
연구 연락처 백업
- 이름: Isa Slotboom, MSc
- 전화번호: +0585111375
- 이메일: isa.slotboom@kliniken-valens.ch
연구 장소
-
-
Canton of St. Gallen
-
Valens, Canton of St. Gallen, 스위스, 7317
- 모병
- Rehabilitation Centre Valens
-
수석 연구원:
- Jens Bansi, PhD
-
연락하다:
- Jens Bansi, PhD
- 전화번호: +41 58 511 13 02
- 이메일: jens.bansi@kliniken-valens.ch
-
연락하다:
- Isa Slotboom, MSc
- 전화번호: +41 58 511 13 02
- 이메일: isa.slotboom@kliniken-valens.ch
-
부수사관:
- Isa Slotboom, MSc
-
부수사관:
- Laura Engler, MSc
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
|
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.
|
|
활성 비교기: 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.
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Balance capacity
기간: From enrollment to the end of treatment at 3 weeks.
|
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.
|
From enrollment to the end of treatment at 3 weeks.
|
|
Cognitive processing speed
기간: From enrollment to the end of treatment at 3 weeks.
|
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.
|
From enrollment to the end of treatment at 3 weeks.
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Mobility
기간: From enrollment to the end of treatment at 3 weeks.
|
Mobility measured by the Timed Up and Go Test (TUG).
Measurement in seconds, a lower time indicates a better functional mobility.
|
From enrollment to the end of treatment at 3 weeks.
|
|
Complex walking ability
기간: From enrollment to the end of treatment at 3 weeks.
|
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.
|
From enrollment to the end of treatment at 3 weeks.
|
|
Fatigue
기간: From enrollment to the end of treatment at 3 weeks.
|
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.
|
From enrollment to the end of treatment at 3 weeks.
|
|
Walking endurance
기간: From enrollment to the end of treatment at 3 weeks.
|
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.
|
From enrollment to the end of treatment at 3 weeks.
|
|
Fear of falling
기간: From enrollment to the end of treatment at 3 weeks
|
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.
|
From enrollment to the end of treatment at 3 weeks
|
|
Health related quality of life
기간: From enrollment to the end of treatment at 3 weeks
|
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.
|
From enrollment to the end of treatment at 3 weeks
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: Jens Bansi, PhD, Klinik Valens
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 5월 6일
기본 완료 (추정된)
2027년 12월 1일
연구 완료 (추정된)
2027년 12월 1일
연구 등록 날짜
최초 제출
2026년 9월 1일
QC 기준을 충족하는 최초 제출
2026년 9월 1일
처음 게시됨 (실제)
2026년 9월 4일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 17일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 14일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .