Trial document




drksid header

  DRKS00011596

Trial Description

start of 1:1-Block title

Title

Evaluation of the effectiveness and costs of home tele-rehabilitation with AGT-Reha in comparison to medical exercise therapy

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

AGT-Reha-WK

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Background
A continuous rehabilitation even after patients discharge from a rehabilitation center is one of the key factors for achieving a sustained rehabilitation success. Therefore, home exercise program focusing on the patient’s own responsibility when performing the exercises can be used. However, many of these exercises are not carried out in the required frequency or course of movements.For these reasons the Peter L. Reichertz Institute for Medical Informatics developed a tele-rehabilitation system consisting of a computer and a Microsoft Kinect camera (called AGT-Reha system). This system focuses on supporting the rehabilitation progress of patients suffering from (chronic) shoulder complain. Thus, it is possible to establish a training program enabling both the self-responsible performance of exercises at the patients’ home as well as the monitoring of exercise quality and frequency by therapists.

Main purpose
On the basis of the study results it should be decided whether the AGT-system can be launched as an alternative or supplement to established aftercare rehabilitation forms.

Study population
Participants of the study are rehabilitations from the “Rehazentrum Bad Pyrmont” who are treated in-patient and suffering from a chronic shoulder complain (i.e. shoulder pain).

Study course
Initially, the subjects of the AGT-Reha group practice three weeks in the rehabilitation center with the AGT-Reha system and thereafter six months at home. The subjects of the comparison group receive the prescribed medical exercise therapy for six months after discharge from rehabilitation center. During the study duration the participants will be regularly contacted to record the medical outcome (i.e. shoulder flexibility and shoulder pain).

Study aims
The aim of the study is to evaluate the effectiveness and costs of the (self-developed) AGT-Reha system in comparison to standard therapy (i.e. medical exercise therapy).

Hypotheses
The aftercare rehabilitation with AGT-Reha is as good as the medical exercise therapy. The costs of AGT-Reha do not exceed the costs of medical exercise therapy.

Amendment from May 22, 2018
During the execution of the trial it became apparent that some exclusion criteria were not formulated in a sufficiently precise manner.
Therefore, these criteria were specified.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

A pilot study by the collaborative AGT-Reha-Project has already shown both the technical feasibility of the computer-based application system AGT-Reha and the basic acceptance and willingness of the maintaining physiotherapists and rehabilitations. The current phase-III-therapy study supplementary examines the non-inferiority of the therapy with AGT-Reha in comparison to the medical exercise therapy (MET). The effectiveness with the primary endpoint medical rehabilitation success is evaluated by means of the recovery of viability, the return to work as well as the perpetuation and sustainability of training. Since there are already aftercare procedures established in the field of rehabilitation, the intention is to conduct surveys related to economic aspects (e.g. cost comparisons).

For achieving the study goals the study is planned as a two-armed, mono-centric, un-blinded, (mainly) non-randomized trial with a duration of two and a half year. The study duration per subject is seven months plus follow-up three months after completion of the home exercise period. A total of 84 subjects (42 per group) will be included in the study.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00011596
  •   2017/02/06
  •   [---]*
  •   yes
  •   Approved
  •   7313, Ethikkommission der Medizinischen Hochschule Hannover
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   M19.1 -  Post-traumatic arthrosis of other joints
  •   M19.11 -  [generalization M19.1: Post-traumatic arthrosis of other joints]
  •   M19.21 -  [generalization M19.2: Other secondary arthrosis]
  •   M24.41 -  [generalization M24.4: Recurrent dislocation and subluxation of joint]
  •   M75.0 -  Adhesive capsulitis of shoulder
  •   M75.1 -  Rotator cuff syndrome
  •   M75.3 -  Calcific tendinitis of shoulder
  •   M75.4 -  Impingement syndrome of shoulder
  •   M75.5 -  Bursitis of shoulder
  •   M75.8 -  Other shoulder lesions
  •   M75.9 -  Shoulder lesion, unspecified
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Training with AGT-Reha (=tele-rehabilitation system consisting of a computer and a Microsoft-Kinect camera)
    ◾ Frequency: 1 time per day
    ◾ Exercise toll: 10 exercises at 10 repetitions
    ◾ Period of time: 6 months
  •   Medical exercise therapy
    ◾ Frequency: 1 to 2 times per week
    ◾ Exercise toll: 5 exercises at 20 repetitions
    ◾ Period of time: 6 months
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   III
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Shoulder function (flexibility, pain intensity)
◾ Measuring instrument: Shoulder pain and Disability Index
◾ Measuring point: Discharge from rehab, six months after rehab, continuously one time per month

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Direct costs of AGT-Reha ((re-)procurement costs, maintenance cost, repair costs, running personal costs, handing over and return costs)
◾ Measuring instrument: documentation sheet
◾ Measuring point: continuous

Direct costs of medical exercise therapy (cost of treatment)
◾ Measuring instrument: billing data from the Deutsche Rentenversicherung Braunschweig-Hannover
◾ Measuring point: at the end of the trial

Range of motion
◾ Measuring instrument: neutral-zero-method
◾ Measuring point: discharge from rehab, six months after rehab

Recovery of viability
◾ Measuring instrument: SPE-scale
◾ Measuring point: discharge from rehab, six months after rehab

Ability to work
◾ Measuring instrument: Work Ability Index
◾ Measuring point: discharge from rehab, six months after rehab

Return to work
◾ Measuring instrument: sociodemographic dataset
◾ Measuring point: discharge from rehab, six months after rehab

Sustainability of training
◾ Measuring instrument: catamnesis questionnaire
◾ Measuring point: discharge from rehab, six months after rehab

Psychosocial health
◾ Measuring instrument: HEALTH-49
◾ Measuring point: discharge from rehab, six months after rehab

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2017/03/03
  •   84
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

◾ Sufficient German language skills to fill in questionnaires and to understand simple instructions of the AGT-Reha system
◾ Exercises can be done without risk
◾ Place of residence in lower Saxony (range of 2 hours around Hannover)
◾ Pension insured by Deutsche Rentenversicherung Braunschweig-Hannover

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

◾ Missing declaration of consent
◾ Simultaneous participation in other clinical trials or within the last 30 days
◾ Pregnancy or breastfeeding period
◾ Exercises cannot be done (this also applies in the case of a new disease or an acute recurrence)
◾ Physical or mental constrain avoiding the properly execution of the exercises
◾ Other after rehabilitation form simultaneous
◾ Exercises shall not be executed in consultation with the attending physiotherapist or physician
◾ No adequate recognition by the Kinect camera (exclusively AGT-Reha)
◾ Body Mass Index > 35
◾ Severely restricted willingness in technique (exclusively AGT-Reha)
◾ No basic technical computer skills (exclusively AGT-Reha)

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Peter L. Reichertz Institut für Medizinische Informatik der Technischen Universität Braunschweig und der Medizinischen Hochschule Hannover
    • Mühlenpfordtstr. 23
    • 38106  Braunschweig
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   0531 391 9500
    •   0531 391 9502
    •   [---]*
    •   http://www.plri.de
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Peter L. Reichertz Institut für Medizinische Informatik der Technischen Universität Braunschweig und der Medizinischen Hochschule Hannover
    • Mr.  Dr.-Ing.  Klaus-Hendrik  Wolf 
    • Karl-Wichert-Allee 3
    • 30625  Hannover
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Peter L. Reichertz Institut für Medizinische Informatik der Technischen Universität Braunschweig und der Medizinischen Hochschule Hannover
    • Ms.  Bianca  Steiner 
    • Mühlenpfordtstr. 23
    • 38106  Braunschweig
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Deutsche Rentenversicherung Braunschweig-Hannover
    • Mr.  PD Dr.  Axel  Kobelt 
    • Lange Weihe 6
    • 30880  Laatzen
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.