- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03841552
Efficacy of Augmented Feedback on Lumbar Postural and Movement Control During Physiotherapy and Home Exercise
February 13, 2019 updated by: Markus J. Ernst, Zurich University of Applied Sciences
Efficacy of Augmented Feedback on Lumbar Postural and Movement Control During Physiotherapy and Home Exercise - A Randomized Controlled Pilot Trial
Exercise therapy is effective in improving pain experience and disability in patients with non-specific low back pain (NSLBP) and movement/postural control impairments.
However, patients often find traditional exercises monotonous and discontinue their execution.
Augmented feedback tools (AF) might improve patient adherence and therapy outcomes, but evidence is currently lacking on their effects on movement/postural control.
In a pilot randomised controlled trial (RCT) on a population of patients with NSLBP and movement control impairment, treatment with physiotherapy and home exercise supported by AF is compared to traditional physiotherapy and home exercise treatment without AF (control group).
The primary outcomes are defined as lumbar movement control and postural control, measured using an inertial measurement system.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Zurich
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Winterthur, Zurich, Switzerland, 8400
- Zurich University of Applied Sciences
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- non specific low back pain for at least four weeks
- at least moderate disability (as indicated by an Oswestry disability index (ODI) > 8% (Mannion et al., 2006))
- low levels of biopsychosocial risk factors (STarT Back Screening tool > 4 points) (Hill et al., 2011)
- at least two positive movement control impairment tests (Luomajoki et al., 2008, Sahrmann, 2002)
Exclusion Criteria:
- specific low back pain
- pain in other areas of the body (e.g. neck, head, thoracic spine or arms)
- vertigo or equilibrium disturbances
- systemic diseases (e.g. tumours and diabetes)
- injuries
- surgeries of the legs within the last six months
- medication affecting postural control
- pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Augmented Feedback
The exercises were conducted with the aim of improving postural- and movement control and awareness of the lumbar spine in both treatment groups.
Both groups received nine 30-minute therapy sessions, during which they performed a series of exercises from an exercise catalogue.
The exercises were selected based on their compatibility with the AF-system.
Each patient performed impairment-specific exercises.
The AF group received additional AF feedback during both the therapy sessions and the home exercise program, by combining the exercises with games designed to target movement control, body awareness, and stabilisation exercises.
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An inertial measurement unit (IMU) system is the basis of the augmented feedback (AF) system, where the IMU-system communicates with a laptop using a bluetooth dongle.
The corresponding software includes therapeutic games.
Movements of the lower back and pelvis by the patient are used to control an avatars movement or the graphical interface in computer exercises.
The AF-system provides real-time feedback regarding the patient's performance and helps to rectify incorrect execution of the exercises.
The intervention took place at a physiotherapy clinic and in an home environment.
In the physiotherapy clinic the patients exercised under the supervision of the physiotherapists.
They continued the exercises at home as home exercises.
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Active Comparator: Control Group
The control group performed the impairment-specific exercises without AF.
The control group was able to receive conventional visual feedback, such as use of mirrors, as deemed appropriate by the therapists but no AF.
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Conventional impairment-specific physiotherapy exercises for low back pain patients.The control intervention took place at a physiotherapy clinic and in an home environment.
In the physiotherapy clinic the patients exercised under the supervision of the physiotherapists.
They continued the exercises at home as home exercises.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline ratio of the range of motion (ROM) of the stabilized lumbar spine (ROMLS) over the moving body segment, the hip (ROMHip)
Time Frame: From Baseline to the completion of nine physiotherapy sessions, which are completed after a maximum of five weeks (Swiss standard prescription)
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Movement control was quantified using the ratio of the range of motion (ROM) of the stabilized lumbar spine (ROMLS) over the moving body segment, the hip (ROMHip) during the movement control test (lumbar spine (LS) over the hip)
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From Baseline to the completion of nine physiotherapy sessions, which are completed after a maximum of five weeks (Swiss standard prescription)
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Changes from Baseline of the mean absolute deviation of lumbar agular displacement
Time Frame: From Baseline to the completion of nine physiotherapy sessions, which are completed after a maximum of five weeks (Swiss standard prescription)
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Postural control was quantified using the mean absolute deviation of lumbar angular displacement (MAD)
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From Baseline to the completion of nine physiotherapy sessions, which are completed after a maximum of five weeks (Swiss standard prescription)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2012
Primary Completion (Actual)
April 30, 2013
Study Completion (Actual)
April 30, 2013
Study Registration Dates
First Submitted
February 5, 2019
First Submitted That Met QC Criteria
February 13, 2019
First Posted (Actual)
February 15, 2019
Study Record Updates
Last Update Posted (Actual)
February 15, 2019
Last Update Submitted That Met QC Criteria
February 13, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KEK-ZH-Nr. 2011-0522
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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