Trial document




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  DRKS00023709

Trial Description

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Title

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

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Trial Acronym

MATT-MS

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URL of the Trial

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Brief Summary in Lay Language

Multiple Sclerosis (MS) is a progressing disease of unknown origin. In Germany ca. 250000 patients suffer from a MS, while about 10000 patients per year are newly diagnosed. MS is the leading cause for acquired, non-traumatic disability in adulthood, oftentimes resulting in early retirement and reduction of the quality of life. Especially the cognitive (40-65%) and motor impairment (85%) are the main reason for these impacts on patients’ lives. It is the aim of MS-therapies, like physiotherapy or cognitive therapy, to improve cognition as well as gait and balance. However, in clinical routines this usually happens independently, neglecting the fact, that motor and cognitive functions are related requiring a rather holistic approach. The use of devices and robotics in therapy therefore gained increasing interest. The music-assisted treadmill “Gait Trainer” (GT) 3.1. (Biodex Medical System, 20 Ramsay Road, Shirley, NY, USA) offers the possibility to combine the therapeutic strategies of rhythmical auditory cueing (RAC) and visual feedback (vFB) with gait training. RAC is a well-known therapeutic strategy in the management of Parkinson patients, which is successfully applied in combination with the treadmill training. The requirement to synchronize gait with the beat of the music represents an active cognitive demand, while walking on the treadmill is the motor demand. Even though, RAC is rather known form the Parkinson therapy, studies in MS have shown positive effects on gait parameters as well as the positively motivating character of the music during training. For the underlying mechanisms it is assumed, that RAC functions as a “bottom-up” stimulation bypassing deficient neural networks and inducing neural adaptation resulting in better motor and cognitive performance. It is therefore the aim of the planned project to evaluate the music-assisted treadmill training (MATT) as a new MS-therapy option in a German in-patient rehabilitation setting and to examine preliminary effects of this training on motor and cognitive functions as well as on patient-centered outcomes. Furthermore, patients will rate the training subjectively, which is a new aspect in therapeutic research.

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Brief Summary in Scientific Language

Multiple Sclerosis (MS) is a degenerative disease of unknown origin. In Germany the prevalence is at ca. 250000 patients, while the yearly incidence is at ca. 10000. The inflammatory-degenerative processes in MS cause a multidimensional neurological disease, which is the leading cause for acquired, non-traumatic disability in adulthood oftentimes resulting in early retirement and reduction of the quality of life. Especially the cognitive (40-65%) and motor impairment (85%) are the main reason for these impacts on patients’ lives. It is the aim of non-pharmacological MS-therapies, like physiotherapy or cognitive therapy, to improve cognition as well as gait and balance. However, in clinical routines this usually happens independently, neglecting the fact, that motor and cognitive functions are related entities that require a rather holistic approach. The use of devices and robotics in therapy therefore gained increasing interest. The music-assisted treadmill “Gait Trainer” (GT) 3.1. (Biodex Medical System, 20 Ramsay Road, Shirley, NY, USA) offers the possibility to combine the therapeutic strategies of rhythmical auditory cueing (RAC) and visual feedback (vFB) with gait training. RAC is a well-known therapeutic strategy in the management of Parkinson patients, which is successfully applied in combination with the treadmill training. The requirement to synchronize gait with the beat of the music represents a cognitively active demand, while walking on the treadmill is the motor demand. Even though, RAC is rather known form the Parkinson therapy, studies in MS have shown positive effects on gait parameters as well as the positively motivating character of the music during training. For the underlying mechanisms it is assumed, that RAC functions as a “bottom-up” stimulation bypassing deficient networks and inducing neuroplasticity resulting in better motor and cognitive performance. It is therefore the aim of the planned project to evaluate the music-assisted treadmill training as a new MS-therapy option in a German in-patient rehabilitation setting and to examine preliminary effects of this training on motor and cognitive functions as well as on patient-centered outcomes. Furthermore, patients will rate the training subjectively, which is a new aspect in therapeutic research.

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Do you plan to share individual participant data with other researchers?

Yes

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Description IPD sharing plan:

All of the individual participant data collected during the trial, will be shared, after deidentification.
Furthermore, the study protocol, the statistical analysis plan, and the analytical code will be available.
The data will be available 6 months after publication for the max. of 10 years after study termination.
The data will be provided for researchers providing a methodologically sound proposal.
The data should be used only for the proposed aims.
Contact details for receiving the data will be provided in the publication.

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Organizational Data

  •   DRKS00023709
  •   2021/01/07
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  •   yes
  •   Approved
  •   535/20, Ethik-Kommission der Medizinischen Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn
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Secondary IDs

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Health Condition or Problem studied

  •   G35 -  Multiple sclerosis
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Interventions/Observational Groups

  •   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 final speed, number and duration of breaks, use of handrails, will be documented in a training log on a daily base. After the intervention phase a post-assessment will be conducted, including clinical fatigue (KFE and MSFC), depression (ADS), risk for falls (FES-I, SAFFE, ABC), 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 parameters (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)) as well as training related data (ability to synchronize hand-clapping to a given beat, relevance of training concerning patient’s rehab goals, and usability (SUS). Another six weeks later patients will be contacted over the phone for a telephone follow-up interview, which re-assesses selected clinical (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)) and cognitive parameters (verbal short-term memory (WMS-R), verbal working memory (WMS-R), word-finding (GFWF)).
  •   Regular treadmill training without music (LB): 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 (music-assisted treadmill training, MATT) or the control group (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). Training data, such as adverse events, initial and final speed, number and duration of breaks, use of handrails, will be documented in a training log on a daily base. After the intervention phase a post-assessment will be conducted, including clinical fatigue (KFE and MSFC), depression (ADS), risk for falls (FES-I, SAFFE, ABC), 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 parameters (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)) as well as training related data (ability to synchronize hand-clapping to a given beat, relevance of training concerning patient’s rehab goals, and usability (SUS). Another six weeks later patients will be contacted over the phone for a telephone follow-up interview, which re-assesses selected clinical (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)) and cognitive parameters (verbal short-term memory (WMS-R), verbal working memory (WMS-R), word-finding (GFWF)).
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   II
  •   N/A
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Primary Outcome

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)

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Secondary Outcome

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))

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2021/01/15
  •   68
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional 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.



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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.


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Addresses

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    • Neurologisches Rehabilitationszentrum "Godeshöhe" e.V.
    • Waldstr. 2-10
    • 53177  Bonn
    • Germany
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    • IRCCS Centro Neurolesi “Bonino-Pulejo”
    • Mr.  medical doctor  Rocco Salvatore  Calabrò 
    • S.S. 113, Contrada Casazza
    • 98124  Messina
    • Italy
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    • Neurologisches Rehabilitationszentrum "Godeshöhe" e.V.
    • Ms.  MSc  Mareike  Eschweiler 
    • Waldstr. 2-10
    • 53177  Bonn
    • Germany
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    • Neurologisches Rehabilitationszentrum "Godeshöhe" e.V.
    • Ms.  MSc.  Mareike  Eschweiler 
    • Waldstr. 2-10
    • 53177  Bonn
    • Germany
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Sources of Monetary or Material Support

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    • Neurologisches Rehabilitationszentrum "Godeshöhe" e.V.
    • Waldstr. 2-10
    • 53177  Bonn
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.