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

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-20

Study Completion Date

2020-10-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The overall purpose of the study is to investigate effect of Digitally Supported Home Exercises (DSHE) in different groups for which digitally supported interventions could be beneficial. Balance is altered in individuals with low back pain and requires intervention Thus, the investigators will focus on the effect of DSHE to improve postural balance.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The investigators want to investigate whether a digitally supported exercise program can improve the balance of people with non-specific lower back pain. During the exercise program, a computer game at home is controlled with the help of sensors attached to the body. Second aim is to record the daily activities of the participants and compare them with the back pain.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Low Back Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

2 x 2. Stratified randomization are used to assign patients to groups A and B and participants not receiving treatment to groups C and D. Participants are stratified by an average height.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Participants will be informed, instructed and provide consent to the study assistant, while assessments will be taken by a measurement assistant, blinded to the group assignment. Data which is not collected in all groups (e.g. intervention adherence) will be collected and managed by the study assistant.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Digitally supported home exercises

Intervention Type OTHER

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

Group Type NO_INTERVENTION

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.

Group Type EXPERIMENTAL

Digitally supported home exercises

Intervention Type OTHER

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Valedo home

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with chronic unspecific low back pain
* 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

* Patients with specific causes for low back pain
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

ETH Zurich

OTHER

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jaap Swanenburg, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital Zurich, Directorate of Research and Education, Physiotherapy & Occupational Therapy Research

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 35687390 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BASEC-Nr: 2018-02132

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.