Trial document





This trial has been registered retrospectively.
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  DRKS00005353

Trial Description

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Title

Comparison of a structured progressive task-oriented circuit Training with an individual face-to-face physiotherapy program regarding walking competency after stroke

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Trial Acronym

Fit-stroke

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Most patients who suffer a stroke experience reduced walking competency. A recent meta-analysis showed that task-oriented circuit training in groups is effective in improving walking competency after stroke.
Objectives: The primary aim is to compare the effects of a structured, progressive task-oriented fitness training programme , applied in a group of 8 to 10 patients, with individually tailored face-to-face- physiotherapy during in-patient Rehabilitation in Terms of walking competency. Further the effect of either training is elevuated regarding quality of life. .
Intervention: Patients in the experimental group will receive fitness Training 5 times a week (a 90 min.) for 6 weeks, whereas patients allocated to the control group will receive the same amount of Training of individual physiotherapy. Outcome parameters are evaluated at 6 weeks and at 24 weeks after randomisation.

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Brief Summary in Scientific Language

Most patients who suffer a stroke experience reduced walking competency. A recent meta-analysis showed that task-oriented circuit training in groups is effective in improving walking competency after stroke.
Objectives: The primary aim is to evaluate the effects of a structured, progressive task-oriented fitness training programme ), applied in a group of 8 to 10 patients, on outcome in terms of gait, gait-related ADLs after stroke, compared to individually tailored physiotherapy during in-patient rehabilitation. The second objective is to investigate the generalisability of treatment effects of task-oriented fitness training in terms of perception of fatigue, anxiety and depression .Study design: A single-blinded randomised controlled trial.
Intervention: Patients in the experimental group will receive fitness Training 5 times a week for 6 weeks, whereas patients allocated to the control group will receive the same amount of Training of individual physiotherapy. Primary outcome will be the mobility part of the Stroke Impact Scale (SIS-3.0) .
Outcome parameters are evaluated at 6 weeks and at 24 weeks after randomisation.

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Organizational Data

  •   DRKS00005353
  •   2013/11/18
  •   [---]*
  •   yes
  •   Approved
  •   143-2008, Ethikkommission an der Medizinischen Fakultät der Universität Leipzig
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Secondary IDs

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

  •   I63.3 -  Cerebral infarction due to thrombosis of cerebral arteries
  •   I61.1 -  Intracerebral haemorrhage in hemisphere, cortical
  •   I63.4 -  Cerebral infarction due to embolism of cerebral arteries
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Interventions/Observational Groups

  •   progressive task-oriented 90 minutes of circuit Training in a Group Setting, 5 days a week, for 6 weeks
  •   Task-oriented individually tailored 90 minutes of face-to-face physiotherapy, 5 days a week, for 6 weeks
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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

Stroke Impact scale Version 3.0 , the mobility domain,a self reported scale including 9 questions, performed after 6 weeks of Training and after 24 weeks post inclusion in the study

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Secondary Outcome

Secondary outcomes include
other domains of the stroke impact scale (version 3.0)related to activities and
participation , the Rivermead mobility index (RMI), the falls efficacy scale (FES),the Nottingham extended activities of daily living (NEADL), the hospital anxiety and depression scale (HADS), and thefatigue severity scale (FSS). Other secondary outcomes were performance tests—namely, the Motricity index (MI-arm and MI-leg), functional ambulation categories, six minute walktest, five meter comfortable walking speed test.
All assessments were measured 6 and 24 weeks after inclusion in the study.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2008/11/10
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

1. Patients aged 18-70 years old after having suffered their first stroke with a resulting hemiparesis. They must be able to walk 10 meters (with or without an aid) by themselves without falling. 2. the stroke has to be verified by CCT or MRI. 3.the patients have to be able
to give informed consent and be motivated to participate in a
6 week intensive programme of physiotherapy.
4. Description of patients by lesion side, and ADL-competency with the Barthel Index and NIH Stroke Scale

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Exclusion Criteria

Patients were
excluded 1. if they had cognitive deficits as evaluated by the
mini-mental state examination (<24 points), were unable to
communicate
2. had a multimodal neglect
3. had other neurologic disease (i.e. Parkinson Disease, multiple sclerosis) or 4. others affecting the musculosceletal System 5. Diabetes melitus with neurologic complications (polyneuropathy)
6. malignant Tumor 7. or participated in other studies

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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 BennewitzUniversität Leipzig
    • Muldentalweg 1
    • 04828  Bennewitz
    • Germany
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    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2012/05/02
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Trial Publications, Results and other Documents

  •   Renner C, Outermans J, Ludwig R, Brendel C, Kwakkel G, Hummelsheim H. (2015). Group therapy task training versus individual task training during inpatient stroke rehabilitation: A randomised controlled trial. Clin Rehabil. Jul;30(7):637-48.
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* This entry means the parameter is not applicable or has not been set.