Trial document




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  DRKS00027558

Trial Description

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Title

Feasibility of a cognitive-motor balance training (StepIt) for people with Parkinson's disease in an inpatient rehabilitation setting

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Trial Acronym

StepIt

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URL of the Trial

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Brief Summary in Lay Language

In this project the feasibility of the training approach "StepIt", which was originally developed for healthy older adults by the team around Prof. Zijlstra and Dr. Giannouli at the German Sports University Cologne, will be evaluated as a possible intervention for people with Parkinson's disease (pwPD) during their inpatient rehabilitation.
StepIt contains aspects of balance, coordination, and gait trainings that are already established in the rehabilitation of pwPD. Furthermore, it applies the strategy of cueing (rhythmic auditive pace giver), which was found to be especially effective in motor rehabilitation of pwPD and are therefore recommended in the European Guidelines for Physiotherapy in pwPD. However, oftentimes these approaches are applied independent form each other and not systematically combined, which might be a reason for limitation, especially when considering the transfer to activities of daily living.
Everyday life puts complex demands upon us that cannot be strictly separated into movement and cognitive tasks. On the contrary, oftentimes it requires moving and thinking at the same time. These complex circumstances need to be reflected in training approaches, for them to be meaningful.
These aspects were considered when developing “StepIt” and are therefore crucial elements of the training program, systematically and individually targeting movement and cognition. As the elements of “StepIt” are highly relevant in the rehabilitation of pwPD, as well, we designed this feasibility study to evaluate if the training program can be transferred to the inpatient rehabilitation of pwPD.

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Brief Summary in Scientific Language

In the study it will be investigated, whether the analogue version of the cognitive-motor StepIt training, that was originally developed for healthy older adults, can be applied in and incorporated into the inpatient rehabilitation of people with Parkinson's disease (pwPD). The StepIt training is considered to combine relevant therapeutic aspects for pwPD that are, until now, oftentimes rarely applied in rehabilitation (step training instead of just postural control training) or treated as separated entities (cognition and motor function). Furthermore, the analogue version is at low cost, and if feasible, it could be expanded as a group therapy and patients could be introduced to the training during their in-patient stay and afterwards continue training at home. For this, a feasibility study was planned for the inpatient rehabilitation, evaluating feasibility in terms of i) acceptance, adherence and safety of this training in the inpatient rehabilitation setting, ii) usability and user experience by pwPD, and iii) exercise performance. The data analysis will be explorative and descriptive. Results will be published and inform further research and optimization of therapy.

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

Yes

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Description IPD sharing plan:

Study data will be made available up on request via an online data management platform after study termination and publication of results.

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Organizational Data

  •   DRKS00027558
  •   2022/01/06
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  •   yes
  •   Approved
  •   058/21, Ethikkommission der Deutschen Sporthochschule Köln
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Secondary IDs

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Health Condition or Problem studied

  •   G20 -  Parkinson disease
  •   Parkinson's disease (idiopathic parkinson syndrom)
    ICD-10-GM G20.-
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Interventions/Observational Groups

  •   After the baseline assessment study-participants will receive 30 minutes one-on-one StepIt training sessions, daily, for two weeks (30 min/ day for 10 days = 5 hours of training).
    For the StepIt training an anti-slippery 90 x 90 cm yoga mat with nine equal number fields (30 x 30 cm) will be used.
    The supervising therapist will explain and demonstrate stepping sequences (e.g. 3-5-6) on a white board and on the mat. The task is for the participant to memorize and then execute the demonstrated sequence in the tempo that is given by a metronome. When the participant performs the sequence correctly, the sequence will be advanced to the next level. The difficulty level will be increased in following ways:
    Within the session:
    1. At first participants will step with one leg at a time (the other leg remains on the start field) only, later on they will step with both legs.
    2. Speed will be advanced from low (55bpm), to moderate (65bpm) to a fast pace (75bpm). These speeds are predefined.
    From session to session:
    1. Training session 1-3: single task (steps only)
    2. Training session 4-7: dual-task (steps + motor task (e.g. balance an object in the hands)
    3. Training session 8-10: multi-tasking (steps + motor task + cognitive task (e.g. word fluency task)
    Additionally, the number of steps per sequence will be increased every two training sessions.
    An experienced physio- or sports therapist, who was instructed in the implementation of the StepIt training, will supervise each training. Furthermore, a study aid will be present in each session to do the documentation and eventually assist the therapist. The study aid was also introduced to the StepIt training.
    After the end of the training phase the post assessment will take place.
    All other rehabilitation treatments remain unchanged and therapy minutes will be documented for comparability.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   II
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Primary Outcome

1. Acceptance, adherence and safety of this training in the inpatient rehabilitation setting
1a. Inclusion-rate: % of participants in relation to eligible patients
1b. Adherence-rate: % of completed trainings in relation to scheduled trainings
1c. Completion-rate: % of participants who completed ≥ 80% of training in relation to all participants
1d. Adverse events: Falls/ almost falls in the direct and indirect context of the StepIt training), terminations of training due to cognitive and/ or motor exhaustion or training-induced pain or unwell-being
2. Usability and user experience by pwPD
2a. Usability of the training: Evaluated by participants applying an adapted form of the Subject Usability Scale (aSUS)
2b. Evaluation of the relevance of the StepIt training (Likert-Scales) to achieve personal rehabilitation goals (defined at the beginning of the rehabilitation with the Goal Attainment Scale, GAS)
2c. Subjectively perceived joy in the overall training: Physical Activity Enjoyment Scale (PACES)
2d. Subjectively perceived joy in each training session: Visual Analogue Scala (VAS)
2e. Subjectively perceived positive training-effects: self-developed questionnaire
2f. Intention to continue training after the end of the study: self-developed questionnaire
2g. Subjectively perceived cognitive and motor load/ demand during training: NASA Task Load Index (NASA-TXL)
3. Exercise performance
3a. Improvement: Baseline level compared to the highest level achieved
3b. Training load: Number of learned stepping sequences (per session and in overall training)
3c. Speed-error-rate: Errors resulting from speed (yes/ no)
3d. Accuracy-error-rate: Errors caused by stepping outside the correct field

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Secondary Outcome

Cognition: global cognition (Montreal Cognitive Assessment), attention (Test of Attentional Performance (TAP), subtest alertness), executive functions (inhibition: TAP Go/NoGo subtest, flexibility: TAP flexibility subtest, verbal and non-verbal working memory: digit and spatial span of the revised version of the Wechsler Memory Scale (WMS-R)); motor function: mobility (Mini-BEST, Timed Up and Go Test without and with dual task, 10m walk test), functional independance (Functional independance Measure, FIM), motor deficit (Unified Parkinson's disease Rating Scale (MDS-UPDRS), motor part III); sociodemographic and clinical data: age, gender, education level, bodyweight, height, profession, marital status, living situation, time since diagnosis, deep brain stimulation (DBS), (time since DBS surgery), degree of illness, mood, quality of life, physical activity level, fatigue, freezing, subjective fear of falling

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2022/01/16
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Persons with Parkinson’s disease; A degree of illness corresponding to Hoehn & Yahr stage I-IV; No conflicting neurological or psychiatric illness that prevent study participation; No other conflicting illness (e.g. cardiac or orthopedic) that would not allow training participation; Unimpaired or corrected vision and hearing; Participants are native German speakers or have a sufficient level of German to understand test and training instructions; Participant is able to follow instructions; Participant is able and willing to provide the written informed consent

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Exclusion Criteria

A degree of illness corresponding to Hoehn & Yahr stage V; Severely impaired vigilance, speech, and mental health, that conflict with comprehension of the study protocol, test or training instructions or the provision of informed consent; Severe fluctuations of medication or variations in DBS settings that conflict with training safety; Cardiac and / or orthopedic diseases contraindicated to participate in training

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Addresses

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    • Deutsche Sporthochschule Köln Institut für für Bewegungs- und Sportgerontologie
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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    • ETH Zurich Department of Health Sciences and Technology Institute of Human Movement Sciences and Sport Motor Control & Learning Group
    • Ms.  Dr.  Eleftheria  Giannouli 
    • Leopold-Ruzicka-Weg 4
    • 8093  Zürich
    • Switzerland
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    • Deutsche Sporthochschule Köln (DSHS) Institut für Bewegungs- und Sportgerontologie
    • Mr.  Prof. Dr.  Wiebren  Zijlstra 
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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    • Neurologisches Rehabilitationszentrum "Godeshöhe" e.V. Abteilung für Therapiewissenschaften
    • Ms.  MSc  Mareike  Eschweiler 
    • Waldstr. 2-10
    • 53177  Bonn
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Sporthochschule Köln (DSHS) Institut für Bewegungs- und Sportgerontologie
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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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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