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NCT Number: NCT07805850

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rehabilitation Centre Valens

Valens, Canton of St. Gallen, 7317, Switzerland

Location status: Recruiting

Location contact

Isa Slotboom, MSc

CONTACT

[email protected]

+41 58 511 13 02

Isa Slotboom, MSc

SUB_INVESTIGATOR

Jens Bansi, PhD

CONTACT

[email protected]

+41 58 511 13 02

Jens Bansi, PhD

PRINCIPAL_INVESTIGATOR

Laura Engler, MSc

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Balance training

Other

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.

Sporttherapy

Other

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.

Primary outcomes

  1. Balance capacity

    Time frame: From enrollment to the end of treatment at 3 weeks.

    Balance capacity measured by the Mini Balance Evaluation system Test (Mini-Best).

Secondary outcomes

  1. Mobility

    Time frame: From enrollment to the end of treatment at 3 weeks.

    Mobility measured by the Timed Up and Go Test (TUG)

  2. Complex walking ability

    Time frame: From enrollment to the end of treatment at 3 weeks.

    Complex walking ability measured by the Six Spot Step Test (SSST)

  3. Fatigue

    Time frame: From enrollment to the end of treatment at 3 weeks.

    Fatigue measured with the Fatigue Scale for Motor and Cognitive Function (FSMC)

  4. Walking endurance

    Time frame: From enrollment to the end of treatment at 3 weeks.

    Walking endurance measured with the 6 Minute Walking Test

Study contacts

Contact information is provided by the study sponsor or research team.

Isa Slotboom, MSc

CONTACT

[email protected]

+0585111375

Jens Bansi, PhD

CONTACT

[email protected]

+41 58 511 13 02

Sponsors and collaborators

Lead sponsor

Klinik Valens

Other

Registry information

Acronym: BALANCE-MS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 4, 2026
Registry last updated
Sep 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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