Monitoring Intensity During Balance Training in Persons With Multiple Sclerosis - a Randomized Feasibility Study (BALANCE-MS)

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis; Balance
• Intervention / Treatment: Other: Balance training; Other: Sporttherapy

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jens Bansi, PhD; Phone Number: +41 58 511 13 02; Email: jens.bansi@kliniken-valens.ch
• Study Contact Backup: Name: Isa Slotboom, MSc; Phone Number: +0585111375; Email: isa.slotboom@kliniken-valens.ch

Study Locations

• Switzerland
  • Canton of St. Gallen
    • Valens, Canton of St. Gallen, Switzerland, 7317
      • Recruiting
      • Rehabilitation Centre Valens
      • Principal Investigator: Jens Bansi, PhD
      • Contact: Jens Bansi, PhD; Phone Number: +41 58 511 13 02; Email: jens.bansi@kliniken-valens.ch
      • Contact: Isa Slotboom, MSc; Phone Number: +41 58 511 13 02; Email: isa.slotboom@kliniken-valens.ch
      • Sub-Investigator: Isa Slotboom, MSc
      • Sub-Investigator: Laura Engler, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: 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.
Active Comparator: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Balance capacity	Balance capacity measured by the Mini Balance Evaluation system Test (Mini-Best).	From enrollment to the end of treatment at 3 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mobility	Mobility measured by the Timed Up and Go Test (TUG)	From enrollment to the end of treatment at 3 weeks.
Complex walking ability	Complex walking ability measured by the Six Spot Step Test (SSST)	From enrollment to the end of treatment at 3 weeks.
Fatigue	Fatigue measured with the Fatigue Scale for Motor and Cognitive Function (FSMC)	From enrollment to the end of treatment at 3 weeks.
Walking endurance	Walking endurance measured with the 6 Minute Walking Test	From enrollment to the end of treatment at 3 weeks.

Collaborators and Investigators

• Sponsor: Klinik Valens
• Investigators: Principal Investigator: Jens Bansi, PhD, Klinik Valens

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: September 1, 2026
• First Submitted That Met QC Criteria: September 1, 2026
• First Posted (Actual): September 4, 2026

Study Record Updates

• Last Update Posted (Actual): September 4, 2026
• Last Update Submitted That Met QC Criteria: September 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Training; Balance; Gait; Walking; Intensity; Postural Control
• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis
• Other Study ID Numbers: BALANCE-MS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No