Music-assisted treadmill training in the rehabilitation of patients with Multiple Sclerosis

• Register: German Clinical Trials Register
• Last refreshed on: 7 April 2025
• Main ID: DRKS00023709
• Date of registration: 07/01/2021
• Prospective Registration: Yes
• Primary sponsor: Neurologisches Rehabilitationszentrum "Godeshöhe" e.V.
• Public title: Music-assisted treadmill training in the rehabilitation of patients with Multiple Sclerosis
• Scientific title: Music-assisted treadmill training in the rehabilitation of patients with Multiple Sclerosis - MATT-MS
• Date of first enrolment: 14/01/2021
• Target sample size: 68
• Recruitment status: Recruiting
• URL: http://drks.de/search/en/trial/DRKS00023709
• Study type: interventional
• Study design: Allocation: Randomized controlled study; Masking: Open (masking not used); Control: active; Assignment: parallel; Study design purpose: treatment
• Phase: 2

Countries of recruitment

Germany

Contacts

• Name: Mareike Eschweiler
• Affiliation: Neurologisches Rehabilitationszentrum "Godeshöhe" e.V.

• Name: Mareike Eschweiler
• Affiliation: Neurologisches Rehabilitationszentrum "Godeshöhe" e.V.

Key inclusion & exclusion criteria

Inclusion criteria: MS diagnosis according to Lublin criteria confirmed by a medical doctor.
No contraindications against treadmill training.
No other neurological or psychiatric illness that limit comprehension of the study protocol and/ or to give an informed consent, understanding test- and/ or training instructions, and safety concerns. Moreover patients must not have illnesses that cause concurrent cognitive and/ or motor impairment have.
Patients are able and willing to provide a written informed consent.




Exclusion criteria: Continuously changing medication.
insufficient knowledge of the German language to follow test- and/ or training instructions.
Uncorrected auditory or visual impairment.
Severe cognitive impairment (criteria: Montreal Cognitive Assessment (MoCA) > 17 points; Freitas et al., 2014).
Scheduled length of stay of less than 14 days, which would not allow completing the study protocol.




Age minimum: None
Age maximum: None
Gender: All

Health Condition(s) or Problem(s) studied

G35

Multiple sclerosis

Intervention(s)

Group 1: Music-assisted treadmill training (MATT): If a patient decides to participate in the study (written informed consent necessary) he/ she undergoes the baseline assessment (T0). During that sociodemographic (age, gender, education, profession, marital status, housing situation, musicality), clinical (MS form, locations of sclerosis, years since diagnosis, years since symptomatic manifestation, disease severity, medication, self-efficacy (FERUS), fatigue (KFE and MSFC), depression (ADS), risk for falls (FES-I, SAFFE, ABC), physical activity level (IPAQ), functional independence (FIM), quality of life (MSQoL-54)), motor (fine motor function (NHPT), walking speed (T25FW), steps/ min, gait security (TUG), dual-task walking (DTGT), balance (BBS), walking capacity (6mWT)), and cognitive data (processing speed (PASAT), attention (TAP), flexibility (TAP), inhibition (TAP), visuo-cognition (TAP), verbal and non-verbal short-term memory (WMS-R), verbal and non-verbal working memory (WMS-R), word-finding (GFWF)) will be collected. Furthermore, training related parameters will be obtained: ability to synchronize hand-clapping to a given beat, patient’s rehab goals (GAS). After baseline-testing patients will be randomized into the experimental (MATT) or the control group (regular treadmill training without music, LB). Patients in both groups receive 10 training sessions, each 30 minutes long. The goal is a training-adherence rate of 80%. Patients rate their motivation and mood (4-level likert scale) before each training as well as their exhaustion and fun after each training (4-level likert scale). The daily training sessions will be video taped to evaluate the percentage of synchronized steps post-training. Additionally, training data, such as adverse events, initial and fin

Primary Outcome(s)

Acceptance: Participation rate (% of participating patiens in relation to eligible patients, constant documentation, evaluation in the final analysis), training-adherence-rate (% of absolved trainings in relation to scheduled trainings, constant documentation, evaluation in the final analysis), completion-rate (% of completing patients in relation to included patients, constant documentation, evaluation in the final analysis), adverse events (eg. falls/ almost falls, training abortions due to motor or cognitive exhaustion as well as training induced unwell-being or pain, constant documentation, evaluation in the final analysis)
Feasibility: Rehab goals (Goal Attainment Scale, T0), Usability of the training (System Usability Scale, T1), relevance of the training to achieve personal goals (4-level Likert Scales to rate how far the goals set at T0 were achieved during training, T1), patients’ rating of the training concerning motivation, mood, fun, and exhaustion (4-level Likert Scales, daily (motivation and mood rated before training, fun and exhaustion are rated after training), ability to synchronize steps to metronome/ music (video evaluation on daily base rating percentage of steps in synchronization with the beat, overall percentage used in the final analysis)

Secondary Outcome(s)

Cognition (processing speed (TAP), attention(TAP), flexibility (TAP), inhibition (TAP), visuo-cognition (TAP), verbal and non-verbal memory (WMS-R), working memory (WMS-R), word finding ability (GFWF))

Motor function (hand function (NHPT), walking speed (T25FW), steps/ min, safety of gait (TUG), dual-task gait (DTGT), balance (BBS), walking endurance (6MinWT))

clinical data (fatigue (FSMC), depression (ADS), fear of falling (FES-I, SAFFE, ABC), physical activity level (IPAQ), functional independence (FIM), quality of life (MSQOL-54))

Source(s) of Monetary Support

Neurologisches Rehabilitationszentrum "Godeshöhe" e.V.

Ethics review

Status: Approved
Approval date: 28/12/2020
Contact:

[e-mail]

Ethik-Kommission Medizinische Fakultät Bonn

[phone]

[e-mail]

Results

• URL: http://drks.de/search/en/trial/DRKS00023709#studyResults