Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00000732

Trial Description

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Title

Mirror Therapy as group intervention for patients after stroke - a randomised controlled trial

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Trial Acronym

MIRaGe

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Hemiparesis is one of the most frequent impairments after a stroke. Due to a poor prognosis of recovery, particulary the severe paresis of the arm is in focus of the development of new therapeutic methods. Mirror therapy uses the reflection of a mirror placed in the mid of the two limbs and positioned with the reflecting side in the direction of the unimpaired arm. Thus the patient see the movements of the unimpaired arm in the mirror like a moving impaired limb. The aim of the present study is to evaluate the effects of mirror therapy organised as a group intervention for patients with a severe paresis of the arm after a stroke.

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Brief Summary in Scientific Language

Aim: The aim of the present study is to evaluate the effectiveness of mirror therapy organised as a group intervention on upper extremity motor function in patients with a severe arm paresis after a stroke.
Methods: Patients are randomly assigned to one of three groups: Mirror therapy as a group intervention, Sham therapy as a group intervention, Mirror therapy as a one to one treatment. Patients participate in 20 treatment sessions over 4 weeks with 30 minutes each. Before and after the intervention, and 6 months after the intervention the following primary variables are assessed: motor function of the upper extremity with the Fugl-Meyer Assessment and the Action Research Arm Test. Secondary variables are: somatosensory impairment, passive range of motion, and pain (Fugl-Meyer Assessment), muscle hypertonia (modified Ashworth Scale), activities of daily living (Barthel Index), and quality of life (Stroke Impact Scale). The assessment of the primary variables are blinded to group allocation.

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Organizational Data

  •   DRKS00000732
  •   2011/02/17
  •   [---]*
  •   yes
  •   Approved
  •   EK-BR-03/09-1, Ethikkommission bei der Sächsischen Landesärztekammer
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   I64 -  Stroke, not specified as haemorrhage or infarction
  •   [---]* -  [---]*
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Interventions/Observational Groups

  •   Mirror Therapy as group intervention: A mirror is placed between the two arms that movements of the non paretic arm are reflected. Thus a visual feedback is created as if the paretic arm is moving. Mirror Therapy is organised in open groups (2 to 6 participants), 20 treatment sessions, 30 minutes each over 4 weeks per protocol. Changes to protocol: Due to organisatorical reasons the intervention time is extended to 5 weeks
  •   Sham Therapy as group intervention: Instead of the reflecting side of the mirror, the non reflecting side is positioned in the direction of the non affected arm, therefore no visual effect exist. Sham therapy is organised in open groups (2 to 6 participants), 20 treatment sessions, 30 minutes each over 4 weeks per protocol. Changes to protocol: Due to organisatorical reasons the intervention time is extended to 5 weeks
  •   Mirror Therapy as single intervention: Mirror Therapy is organised as one to one treatment, 20 treatment sessions, 30 minutes each over 4 weeks per protocol. Changes to protocol: Due to organisatorical reasons the intervention time is extended to 5 weeks
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Single blind
  •   assessor
  •   Placebo, Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   [---]*
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Primary Outcome

Outcome: motor function of the upper extremity;
measurement points: before the intervention (t0), after 4 weeks of intervention (t1) and 6 months after the intervention (t2) per protocol;
Assessment: Fugl-Meyer-Assessment, Action Research Arm Test;
Changes to protocol: Due to organisatorical reasons the follow-up assessment t1 is set on the end of the 5 week intervention period and t2 on 7 months after the intervention. Follow-up t2 discontinued due to organisatorical reasons.

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Secondary Outcome


Outcome: somatosensibility, passive range of motion, pain, muscle hypertonia, activities of daily living, quality of life;
measurement points: before the intervention (t0), after 4 weeks of intervention (t1) and 6 months after the intervention (t2) per protocol;
Assessment: Fugl-Meyer-Assessment (somatosensibility, passive range of motion, pain), modified Ashworth Scale (muscle hypertonia), Barthel Index (activities of daily living), Stroke Impact Scale (quality of life)
Changes to protocol: Due to organisatorical reasons the follow-up assessment t1 is set on the end of the 5 week intervention period and t2 on 7 months after the intervention. Follow-up t2 discontinued due to organisatorical reasons.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2009/04/28
  •   66
  •   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 supratentorial stroke with a maximum of 3 months before study entry, severe hemiparesis of the upper extremity

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Exclusion Criteria

visual impairments, which may limit the participation on mirror therapy; severe cognitive and/ or language deficits which preclude them from following instruction in the group training protocol; other neurological or musculoskeletal impairments of the upper extremity not due to stroke; a severe neglect

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Addresses

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    • Erste Europäische Schule für Physiotherapie, Ergotherapie und Logopädie, Klinik Bavaria Kreischa
    • Mr.  M.Sc.  Holm  Thieme 
    • Dresdner Str. 12
    • 01731   Kreischa
    • Germany
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  • start of 1:1-Block address scientific-contact
    • Erste Europäische Schule für Physiotherapie, Ergotherapie und Logopädie, Klinik Bavaria Kreischa
    • Mr.  M.Sc.  Holm  Thieme 
    • Dresdner Str. 12
    • 01731   Kreischa
    • Germany
    end of 1:1-Block address scientific-contact
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    • Erste Europäische Schule für Physiotherapie, Ergotherapie und Logopädie, Klinik Bavaria Kreischa
    • Mr.  M.Sc.  Holm  Thieme 
    • Dresdner Str. 12
    • 01731   Kreischa
    • Germany
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Sources of Monetary or Material Support

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    • Erste Europäische Schule für Physiotherapie, Ergotherapie und Logopädie, Klinik Bavaria Kreischa
    • Mr.  M.Sc.  Holm  Thieme 
    • Dresdner Str. 12
    • 01731   Kreischa
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2011/10/13
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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.