Monitoring Intensity During Balance Training in Persons With Multiple Sclerosis

NCT07805850 | Recruiting

• 1 other identifier: BALANCE-MS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis; Balance

Keywords

Balance; Postural Control; Intensity; Multiple Sclerosis; Walking; Gait; Training

Outcome Measures

Primary Outcomes (2)

• Balance capacity

  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

  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.

Secondary Outcomes (6)

• Mobility

  From enrollment to the end of treatment at 3 weeks.

• Complex walking ability

  From enrollment to the end of treatment at 3 weeks.

• Fatigue

  From enrollment to the end of treatment at 3 weeks.

• Walking endurance

  From enrollment to the end of treatment at 3 weeks.

• Fear of falling

  From enrollment to the end of treatment at 3 weeks

Study Arms (2)

Balance training

EXPERIMENTAL

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

Sporttherapy

ACTIVE COMPARATOR

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

Interventions

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.

Balance training

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.

Sporttherapy

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Klinik Valens: lead

Study Sites (1)

Rehabilitation Centre Valens

Valens, Canton of St. Gallen, 7317, Switzerland

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jens Bansi, PhD

  Klinik Valens

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jens Bansi, PhD

CONTACT

+41 58 511 13 02; jens.bansi@kliniken-valens.ch

Isa Slotboom, MSc

CONTACT

+0585111375; isa.slotboom@kliniken-valens.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Bansi, Jens, Head of Valens Research

Model Details: A randomized feasibility study

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 4, 2026
• Study Start: May 6, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 17, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)