Efficacy of Augmented Feedback on Lumbar Postural and Movement Control During Physiotherapy and Home Exercise

NCT03841552 | Completed

• 1 other identifier: KEK-ZH-Nr. 2011-0522
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Low Back Pain

Keywords

Low Back Pain

Outcome Measures

Primary Outcomes (2)

• Change from Baseline ratio of the range of motion (ROM) of the stabilized lumbar spine (ROMLS) over the moving body segment, the hip (ROMHip)

  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)

  From Baseline to the completion of nine physiotherapy sessions, which are completed after a maximum of five weeks (Swiss standard prescription)

• Changes from Baseline of the mean absolute deviation of lumbar agular displacement

  Postural control was quantified using the mean absolute deviation of lumbar angular displacement (MAD)

  From Baseline to the completion of nine physiotherapy sessions, which are completed after a maximum of five weeks (Swiss standard prescription)

Study Arms (2)

Augmented Feedback

EXPERIMENTAL

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.

Device: Augmented Feedback

Control Group

ACTIVE COMPARATOR

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.

Other: Control Group

Interventions

Augmented Feedback DEVICE

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.

Augmented Feedback

Control Group OTHER

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Zurich University of Applied Sciences: lead
• Danube University Krems: collaborator
• MedBase Brunngasse Winterthur: collaborator

Study Sites (1)

Zurich University of Applied Sciences

Winterthur, Canton of Zurich, 8400, Switzerland

Location

Related Publications (1)

• Hugli AS, Ernst MJ, Kool J, Rast FM, Rausch-Osthoff AK, Mannig A, Oetiker S, Bauer CM. Adherence to home exercises in non-specific low back pain. A randomised controlled pilot trial. J Bodyw Mov Ther. 2015 Jan;19(1):177-85. doi: 10.1016/j.jbmt.2014.11.017. Epub 2014 Nov 27.

  PMID: 25603757 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigators who collected the outcome data, as well as the statistician were blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research associate

Model Details: Randomized controlled pilot trial

Study Record Dates

• First Submitted: February 5, 2019
• First Posted: February 15, 2019
• Study Start: October 1, 2012
• Primary Completion: April 30, 2013
• Study Completion: April 30, 2013
• Last Updated: February 15, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)