Monitoring Intensity During Balance Training in Persons With Multiple Sclerosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKlinik Valens
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Balance training
Other interventionThe 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 interventionThe 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Balance trainingExperimental treatment 1 intervention
Group B: SporttherapyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From enrollment to the end of treatment at 3 weeks.2
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.
Time frame
From enrollment to the end of treatment at 3 weeks.Secondary outcomes
1
Mobility
Mobility measured by the Timed Up and Go Test (TUG). Measurement in seconds, a lower time indicates a better functional mobility.
Time frame
From enrollment to the end of treatment at 3 weeks.2
Complex walking ability
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.
Time frame
From enrollment to the end of treatment at 3 weeks.3
Fatigue
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.
Time frame
From enrollment to the end of treatment at 3 weeks.4
Walking endurance
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.
Time frame
From enrollment to the end of treatment at 3 weeks.Sponsors and contacts
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Source ClinicalTrials.gov