Trial document




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  DRKS00019190

Trial Description

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Title

Usefulness of biofeedback training with the Acticore® for patients suffering from anal incontinence

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

In the therapy of fecal incontinence, the physiotherapy treatment and the training of the pelvic floor are very important. The improvement of fecal incontinence through targeted pelvic floor training also using biofeedback methods has already been clinically tested several times
The aim of the pilot study is to use the CE-certified Acticore® to test the effectiveness of pelvic floor training using biofeedback methods. The sensor is not inserted into the body. It is connected to the smartphone via Bluetooth. By sitting on the sensor, he can "playfully control" by tensing and releasing the pelvic floor and gets feedback on the force distribution of the pelvic floor.

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Brief Summary in Scientific Language

The therapy of fecal incontinence through targeted pelvic floor training also using biofeedback methods has already been clinically tested several times
The aim of the pilot study is to use the CE-certified Acticore® to test the effectiveness of pelvic floor training using biofeedback methods. The sensor of the training apparatus is not inserted into the body.
40 patient will recruted and randomized.

It is connected to the smartphone via Bluetooth. By putting the patient on the sensor, he can "playfully control" by tensing and releasing the pelvic floor and gets feedback on the force distribution of the pelvic floor.
The ACTICORE training program was developed in accordance with the P.E.R.F.E.C.T Scheme by Dr. Ing. Jo Laycock built. This pelvic floor training focuses solely on pelvic floor. Other muscle groups are not activated during the exercises. The exercises are designed so that you specifically train the different functions of your pelvic floor muscles. In particular, endurance exercises strengthen your approximately 70 percent slow fibers, which are responsible for the supporting and stabilizing functions of the pelvic floor. Power exercises strengthen your about 30 percent fast fibers. These are primarily responsible for the functioning of the urethral and intestinal obstructions and thus for your continence. Coordination exercises promote communication between the various muscle fibers and the nervous system. This permanent interaction is essential to the functioning of your pelvic floor. Endurance, strength and coordination exercises are divided into 60-second sessions. The training program is progressively structured in eleven performance levels. A performance test at the beginning of the training leads to your own personal starting level. This performance test is automatically offered by the system weekly after seven training sessions and will redefine your level.
The eleven performance levels differ as follows:
Endurance:
Duration of tension
Intensity of tension
Number of stress phases
Duration of the relaxation phases
Explosive strength:
Intensity of tension
Number of interplay between arrival and relaxation
Tempo and duration of the interplay
Duration of the breaks between the arrival and relaxation phases
Coordination:
Interplay between easy, medium and heavy intensity of arrival and relaxation
Interplay in the duration of arrival and relaxation phases
Number of alternating games per exercise unit

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00019190
  •   2019/12/23
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  •   yes
  •   Approved
  •   162/19, Ethikkommission der Medizinischen Fakultät der Otto-von-Guericke-Universität Magdeburg
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Secondary IDs

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Health Condition or Problem studied

  •   R15 -  Faecal incontinence
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Interventions/Observational Groups

  •   out patient physiotherapy of pelvic floor for 6 month
  •   biofeeedback training with the Acticore® 6min daily for 6 month
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Other
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Primary Outcome

Wexner score after 12 weeks pelvic floor training

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Secondary Outcome

Wexner score after 24 weeks pelvic floor training, quality of life after 12 and 24 weeks using EuroQol questionnaire, general well-being after 12 and 24 weeks (VAS scoring)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Planned
  •   2020/03/16
  •   40
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

patients with faecal inontinence
Wexner score of at least greater than 2
Patients ≥ 18 years
Patients who use a smartphone daily
Signed consent

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Exclusion Criteria

pregnancy
Age <18 years
Rejection of study participation by the patient
No regular use of a smartphone

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Helios Klinikum Berlin-Buch
    • Mr.  Dr. med.  Christoph  Paasch 
    • Schwanebecker Chaussee 50
    • 13125  Berlin
    • Germany
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    • Universitätsklinik für Allgemein-, Viszeral-, Gefäß- und Transplantationschirurgie
    • Mr.  Dr. med.  Mihailo  Andric 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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    • Chefarzt der Klinik für Viszeral- und Gefäßchirurgie - Minimal Invasive Chirurgie - Alexianer St. Hedwig Krankenhaus
    • Mr.  Dr. med.  Eric  Lorenz 
    • Große Hamburger Str. 5 - 11
    • 10115  Berlin
    • Germany
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  • start of 1:1-Block address scientific-contact
    • HELIOS Klinikum Berlin-Buch
    • Mr.  Dr. med.  Christoph  Paasch 
    • Schwanebecker Chaussee 50
    • 13125  Berlin
    • Germany
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    • HELIOS Klinikum Berlin-Buch
    • Mr.  Dr. med.  Christoph  Paasch 
    • Schwanebecker Chaussee 50
    • 13125  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • ACTICORE GmbH
    • Mr.  Cohn 
    • Am Alten Berg 1c
    • 63303  Dreieich
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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