Pilot Study on Digitally Supported Home Exercises for the Management of Unspecific Low Back Pain.
NCT ID: NCT04364243
Last Updated: 2021-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
38 participants
INTERVENTIONAL
2019-05-20
2020-10-23
Brief Summary
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Detailed Description
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The 120 participants in this study will be divided into four groups (A, B, C and D). In groups A and B 20 patients are included who are in treatment for chronic back pain and receive Medical Training Therapy (MTT). For groups C and D the investigators will invite each 40 participants who have back pain but are not in treatment for their back pain. Only participants in groups A and C receive the digitally supported home exercise program. Who gets the training program is randomized using stratified block randomization.
The balance of all participants is measured four times. Between the 2nd and 3rd measurement the digitally supported exercise program is carried out. Between the 3rd and 4th assessement, participants in group A and C can exercise as much as they wish. The person who carries out the balance tests will not be informed which participant is in which group.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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Patients exercise
Low back pain patients Next to basic medical physical training therapy group A receive a home exercising programme which involves 10 exercises for 2 minutes each with the Valedo training system.
Digitally supported home exercises
The training will comprise of 9 sessions (3 weekly) Each of the training sessions will last 20 minutes. This will result in a cumulative total intervention exercise time of 180 minutes.
Patients control
Low back pain patients Group B will receive basic medical physical training therapy
No interventions assigned to this group
Non-patients exercise
non-patients Groups C will receive a home exercising programme which involves 10 exercises for 2 minutes each with the Valedo training system.
Digitally supported home exercises
The training will comprise of 9 sessions (3 weekly) Each of the training sessions will last 20 minutes. This will result in a cumulative total intervention exercise time of 180 minutes.
Non-patients control
non-patients Group D will receive no intervention
No interventions assigned to this group
Interventions
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Digitally supported home exercises
The training will comprise of 9 sessions (3 weekly) Each of the training sessions will last 20 minutes. This will result in a cumulative total intervention exercise time of 180 minutes.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients of the Medical Training Therapy (MTT)
* Adult male and female participant's (≥18 years)
* Informed consent as documented by signature
* Participant reports unspecific low back pain
* Receiving no therapy nor medical treatment for the last 6 months
* Adult male and female participant's (≥18 years)
* Informed consent as documented by signature
Exclusion Criteria
* Radicular syndrome
* Unable to participate currently in the program due to pain
* Pregnancy
* Medication effecting postural balance
* Uncorrected heavy visual impairment
* Allergy to adhesive tape
* Unable to understand and communicate in German or English
18 Years
ALL
Yes
Sponsors
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ETH Zurich
OTHER
University of Zurich
OTHER
Responsible Party
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Principal Investigators
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Jaap Swanenburg, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Zurich
Locations
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University Hospital Zurich, Directorate of Research and Education, Physiotherapy & Occupational Therapy Research
Zurich, Canton of Zurich, Switzerland
Countries
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References
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Meinke A, Peters R, Knols RH, Swanenburg J, Karlen W. Feedback on Trunk Movements From an Electronic Game to Improve Postural Balance in People With Nonspecific Low Back Pain: Pilot Randomized Controlled Trial. JMIR Serious Games. 2022 Jun 10;10(2):e31685. doi: 10.2196/31685.
Other Identifiers
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BASEC-Nr: 2018-02132
Identifier Type: -
Identifier Source: org_study_id
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