Trial document




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  DRKS00015819

Trial Description

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Title

Auditory stimulation for improving mobility after stroke

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Background: Auditory stimulation is a rhythmic sensory cueing to enhance gait patterns. Aim of the study is to research the effectiveness of auditory stimulation as an additional treatment for chronic stroke patients.
Methods: Both groups will complete a 4-week gait training. The intervention group additionally will receive auditory stimulation through music via headphones. Balance ability, gait capacity and gait velocity will be assessed before and after interventions as well as 12 weeks later.

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Brief Summary in Scientific Language

Background: Auditory stimulation is a rhythmic sensory cueing to enhance gait patterns. Aim of the study is to research the effectiveness of auditory stimulation as an additional treatment for chronic stroke patients.
Methods: Both groups will complete a 4-week gait training. The intervention group additionally will receive auditory stimulation through music via headphones. Balance ability, gait capacity and gait velocity will be assessed before and after interventions as well as 12 weeks later (follow-up).

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Organizational Data

  •   DRKS00015819
  •   2018/10/29
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  •   yes
  •   Approved
  •   EK312082018, Ethikkommission der Medizinischen Fakultät der Technischen Universität Dresden
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Secondary IDs

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Health Condition or Problem studied

  •   I63 -  Cerebral infarction
  •   I61 -  Intracerebral haemorrhage
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Interventions/Observational Groups

  •   Patients will participate for 4 weeks, 3 times a week for 30 minutes in a standardised mobility training
  •   The intervention group additionally will receive auditory stimulation during walking training
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   assessor, data analyst
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

1. gait velocity [m/s], measured by 10m walk test at the end of intervention period and at 3 months follow-up, 2. gait capacity [m], measured by 6 minute walk test at the end of intervention period and at 3 months follow-up

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Secondary Outcome

1. Balance ability, as measured by the Berg Balance Scale (BBS) at the end of intervention period and at 3 months follow-up, 2. Stride length [cm] as measured by 10m walk test at the end of intervention period and at 3 months follow-up

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Planned
  •   2018/11/01
  •   15
  •   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

(1) Stroke according to the WHO-definition for longer than six months (2) ability to walk six minutes with or without assistive devices in a self-selected walkingspeed

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Exclusion Criteria

(1) brain tumours, (2) decompensated heart failure, (3) chronic shoulder pain post stroke when walking within assistive device

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Addresses

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    • Lehrstuhl Gesundheitswissenschaften/Public Health, Medizinische Fakultät Carl Gustav Carus, Technische Universität Dresden
    • Mr.  Dr.  Bernhard  Elsner 
    • Fetscherstr. 74
    • 01307  Dresden
    • Germany
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    • Lehrstuhl Gesundheitswissenschaften/Public Health, Medizinische Fakultät Carl Gustav Carus, Technische Universität Dresden
    • Mr.  Dr.  Bernhard  Elsner 
    • Fetscherstr. 74
    • 01307  Dresden
    • Germany
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    • Lehrstuhl Gesundheitswissenschaften/Public Health, Medizinische Fakultät Carl Gustav Carus, Technische Universität Dresden
    • Mr.  Dr.  Bernhard  Elsner 
    • Fetscherstr. 74
    • 01307  Dresden
    • Germany
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Sources of Monetary or Material Support

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    • Lehrstuhl Gesundheitswissenschaften/Public Health, Medizinische Fakultät Carl Gustav Carus, Technische Universität Dresden
    • Mr.  Dr.  Bernhard  Elsner 
    • Fetscherstr. 74
    • 01307  Dresden
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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