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

14 de septiembre de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

60

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Suiza
    • Canton of St. Gallen
      • Valens, Canton of St. Gallen, Suiza, 7317
        • Reclutamiento
        • Rehabilitation Centre Valens
        • Investigador principal:
          • Jens Bansi, PhD
        • Contacto:
        • Contacto:
        • Sub-Investigador:
          • Isa Slotboom, MSc
        • Sub-Investigador:
          • Laura Engler, MSc

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
Otro: 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.
Comparador activo: 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.
Otro: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Balance capacity
Periodo de tiempo: 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
Periodo de tiempo: 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.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Mobility
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Klinik Valens

Investigadores

  • Investigador principal: Jens Bansi, PhD, Klinik Valens

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

6 de mayo de 2026

Finalización primaria (Estimado)

1 de diciembre de 2027

Finalización del estudio (Estimado)

1 de diciembre de 2027

Fechas de registro del estudio

Enviado por primera vez

1 de septiembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

1 de septiembre de 2026

Publicado por primera vez (Actual)

4 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

17 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

14 de septiembre de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • BALANCE-MS

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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