Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Monitoring Intensity During Balance Training in Persons With Multiple Sclerosis (BALANCE-MS)

14. September 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

60

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Schweiz
    • Canton of St. Gallen
      • Valens, Canton of St. Gallen, Schweiz, 7317
        • Rekrutierung
        • Rehabilitation Centre Valens
        • Hauptermittler:
          • Jens Bansi, PhD
        • Kontakt:
        • Kontakt:
        • Unterermittler:
          • Isa Slotboom, MSc
        • Unterermittler:
          • Laura Engler, MSc

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Sonstiges: 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.
Aktiver Komparator: 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.
Sonstiges: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Balance capacity
Zeitfenster: 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
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Mobility
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Klinik Valens

Ermittler

  • Hauptermittler: Jens Bansi, PhD, Klinik Valens

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

6. Mai 2026

Primärer Abschluss (Geschätzt)

1. Dezember 2027

Studienabschluss (Geschätzt)

1. Dezember 2027

Studienanmeldedaten

Zuerst eingereicht

1. September 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

1. September 2026

Zuerst gepostet (Tatsächlich)

4. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

17. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

14. September 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • BALANCE-MS

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Abonnieren