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

NCT ID: NCT03841552

Last Updated: 2019-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-01
• Study Completion Date: 2013-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Augmented Feedback

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Control Group

Intervention Type: 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.

Interventions

Augmented Feedback

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.

Intervention Type: DEVICE

Control Group

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Danube University Krems

OTHER

Sponsor Role: collaborator

MedBase Brunngasse Winterthur

UNKNOWN

Sponsor Role: collaborator

Zurich University of Applied Sciences

OTHER

Sponsor Role: lead

Responsible Party

Markus J. Ernst

research associate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zurich University of Applied Sciences

Winterthur, Canton of Zurich, Switzerland

Countries

Switzerland

References

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.

Reference Type: BACKGROUND

PMID: 25603757 (View on PubMed)

Other Identifiers

KEK-ZH-Nr. 2011-0522

Identifier Type: -

Identifier Source: org_study_id