Trial document





This trial has been registered retrospectively.
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  DRKS00009294

Trial Description

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Title

Comparing unilateral and bilateral computer-supported arm training for the severely affected arm after stroke

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Trial Acronym

Arm motormed

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URL of the Trial

[---]*

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Brief Summary in Lay Language

We want to compare the effects of bilateral versus unilateral arm-cycle training on motor recovery in severely affected stroke patients.
Methods: 68 patients with a severe arm paresis are going to receive either unilateral or bilateral arm-cycle training. Both trainings are administered twice daily over six weeks and are followed by a repetitive hand training. Main outcome measures included the assessmants of hand function and biomechanical parameters (hand grip-, hand extension-, elbow flexion- and elbow extension isometric force ) at the beginning, after 6 and 8 weeks.

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Brief Summary in Scientific Language

Introduction: Functional recovery after stroke depends on brain plasticity. Ipsilesional and bihemispheric reorganization have been documented. In addition stroke patients experience an increased inhibitory influence from the contralesional to the ipsilesional motor cortex. Yet there is evidence that patients benefit from both bilateral and unilateral arm training. Therefore we want to compare the effects of bilateral versus unilateral computer-supported arm training on motor recovery in severely affected subacute stroke patients.
Methods: 68 patients with a severe arm paresis (Fugl-Meyer-Score for the arm (FMA) less than 18) are recruited for this randomized single-blinded study. The bilateral arm training entailes a repetitive training on an “arm-bicycle” followed by synchronized bilateral repetitive hand training. The unilateral arm training is identical but performed by the paretic limb only. Both trainings are administered twice daily over six weeks and incorporate shaping elements. Main outcome measures include the FMA and biomechanical parameters (hand grip-, hand extension-, elbow flexion- and elbow extension isometric force and rate of force generation), assessed at the beginning, after 6 and 8 weeks.

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Organizational Data

  •   DRKS00009294
  •   2016/01/28
  •   [---]*
  •   yes
  •   Approved
  •   224-08 , Ethikkommission an der Medizinischen Fakultät der Universität Leipzig
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Secondary IDs

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Health Condition or Problem studied

  •   Infarct in the MCA territory
  •   I63.5 -  Cerebral infarction due to unspecified occlusion or stenosis of cerebral arteries
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Interventions/Observational Groups

  •   Group 1: 6 weeks of bilateral repetitive arm training on an “arm-bicycle” , twice a day for 20 minutes each followed once-a-day synchronized bilateral repetitive hand training, on 5 days per week
  •   Group 2: 6 weeks of unilteral repetitive arm training on an “arm-bicycle” , twice a day for 20 minutes each, followed once-a-day by unilateral repetitive hand training, on 5 days per week
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   investigator/therapist
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Change of Fugl-Meyr-Sccore will be measured 6 and 8 weeks post inclusion

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Secondary Outcome

biomechanical Parameter such as
1. hand extension force (isometric),
2. Rate of rise of tension of hand extension force,
3. elbow flexion and extension force (at an angle of 60degrees, isometric),
4. hand grip force
5. Rate of rise of tension of hand grip force,
will be recorded at T0, T6 and T8

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2011/01/30
  •   68
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

first ever Stroke of MCA (middle cerebral artery)
severe Paresis of upper extremity, 0-2 BMRC (british medical Research council), Fugle-meyr-Score<18

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Exclusion Criteria

Aphasia, previous strokes, other neurologic disease, Spasticity of the arm, shoulder pain on affected side

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Addresses

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    • Universitätsklinikum Leipzig
    • Liebigstr. 18
    • 04103  Leipzig
    • Germany
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    • NRZ Leipzig-Bennewitz,Universität Leipzig
    • Ms.  PD Dr. med. habil.  Caroline  Renner 
    • Muldentalweg 1
    • 04828  Bennewitz
    • Germany
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    • NRZ Leipzig-Bennewitz,Universität Leipzig
    • Ms.  PD Dr. med. habil.  Caroline  Renner 
    • Muldentalweg 1
    • 04828  Bennewitz
    • Germany
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Sources of Monetary or Material Support

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    • NRZ Leipzig-Bennewitz,Universität Leipzig
    • Ms.  PD Dr. med. habil.  Caroline  Renner 
    • Muldentalweg 1
    • 04828  Bennewitz
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/10/01
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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.