Trial document




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  DRKS00010009

Trial Description

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Title

ReMove-It - Efficacy study of rehabilitation with telemedical assisted movement therapy after lower extremity intervention

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Trial Acronym

ReMove-It

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URL of the Trial

http://www.uni-potsdam.de/rehawiss/forschung/projekte/remove-it-wirksamkeitsstudie-einer-telemedizinisch-assistierten-bewegungstherapie-fuer-die-rehabilitation-nach-intervention-an-der-unteren-extremitaet.html

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Brief Summary in Lay Language

The ReMove-It study, based on the system MeineReha®, investigates a telemedical assisted training intervention for patients after total knee or hip arthroplasty, evaluating feasibilty and effectiveness. The telemedicine training program can be used at home on a television. Here the trainee is facing the screen and gets its exercises shown. Using an installed on-screen camera, the patient gets individual corrections to its exercise execution on the screen. The individually tailored training plan with exercises such as squats is created and looked after by a physiotherapist in the rehabilitation clinic.

The aim of the intervention is to ensure or increase the medium- and long-term sustainability of the rehabilitation success especially in structurally weak areas. The findings can afterwards be transferred to other fields of orthopedics (trunk and upper extremity).

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Brief Summary in Scientific Language

At first, researchers from the University of Potsdam and Fraunhofer FOKUS develop therapy elements for patients after intervention of the lower limb in collaboration with the therapists in the participating rehabilitation clinics. These are reviewed on technical feasibility by Fraunhofer FOKUS with the development and verification of algorithms and then implemented into the system subsequently.
In a second phase, in a multicenter randomized controlled trial with two time points of investigation (shortly after the inpatient rehabilitation and three months later), the effect of a three-month telemedically assisted exercise program on physical performance, functional mobility, quality of life, postural control, pain and return to work is examined.

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Organizational Data

  •   DRKS00010009
  •   2016/05/11
  •   [---]*
  •   yes
  •   Approved
  •   15/2016, Ethikkommission der Universität Potsdam
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Secondary IDs

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

  •   M16.1 -  Other primary coxarthrosis
  •   M17.1 -  Other primary gonarthrosis
  •   M16.5 -  Other post-traumatic coxarthrosis
  •   M17.3 -  Other post-traumatic gonarthrosis
  •   Patients after total knee or hip arthroplasty
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Interventions/Observational Groups

  •   Three-month telemedically assisted exercise therapy at home, based on the system MeineReha® (after inpatient rehabilitation)
    The telemedicine training program can be used at home on a television. Here the trainee is facing the screen and gets its exercises shown. Using an installed on-screen camera, the patient gets individual corrections to its exercise execution on the screen. The individually tailored training plan with exercises such as squats is created and looked after by a physiotherapist in the rehabilitation clinic.
  •   Control group: usual care (after inpatient rehabilitation)
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Control group receives no treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Difference in exercise capacity (6-minute walk test [m]) between end and start of intervention

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Secondary Outcome

Difference in walking speed (electro-optical passive marker system), functional mobility (Timed Up and Go, Chair Rise and Stair Ascend test), postural control (one-leg stand on a force plate), quality of life and pain (questionnaires SF36 and WOMAC) between intervention end and -beginn and rate of return to work.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2016/08/15
  •   110
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Implantation of total hip or knee replacement after idiopathic/posttraumatic/congenital osteoarthritis

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Exclusion Criteria

No functional safety in walking with full load at the end of inpatient rehabilitation in order to perform progressive exercises with adequate load and measurements at the UP

- Insufficient knowledge of the German language (spoken and written)

Technical exclusion criteria
- No HDMI compatible TV (flat screen TV)
- Less than 2.5 m in front of the screen
- No internet connection (wireless or Ethernet)

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Addresses

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    • Universität Potsdam, Professur für Rehabilitationswissenschaften
    • Am Neuen Palais 10
    • 14469  Potsdam
    • Germany
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    • Fraunhofer-Institut für Offene Kommunikationssysteme FOKUS
    • Mr.  Dr.  Michael  John 
    • Kaiserin-Augusta-Allee 31
    • 10589  Berlin
    • Germany
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    • Brandenburg Klinik Berlin-Brandenburg
    • Mr.  Dr. med.  Horst  Reich 
    • Brandenburgallee 1
    • 16321  Bernau-Waldsiedlung
    • Germany
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    • MEDIAN Klinik Hoppegarten
    • Mr.  Dr. med.  Frank  Thomas 
    • Rennbahnallee 107
    • 15366  Hoppegarten
    • Germany
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    • Reha-Zentrum Lübben
    • Mr.  Dr. med.  Maik-Percy  Hentschke 
    • Postbautenstraße 50
    • 15907  Lübben
    • Germany
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    • Universität Potsdam, Professur für Rehabilitationswissenschaften
    • Mr.  Prof. Dr. med.  Heinz  Völler 
    • Am Neuen Palais 10, Haus 12
    • 14469  Potsdam
    • Germany
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    • Universität Potsdam, Professur für Rehabilitationswissenschaften
    • Ms.  Sarah  Eichler 
    • Am Neuen Palais 10, Haus 12
    • 14469  Potsdam
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Rentenversicherung Berlin-Brandenburg
    • Bertha-von-Suttner-Straße 1
    • 15236  Frankfurt (Oder)
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Universität Potsdam
    • Am Neuen Palais 10
    • 14469  Potsdam
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2017/12/21
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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.