Evaluation of Balance Using the Biodex Balance System Among Different Subcategories of Low Back Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-55
SponsorCairo University
About this trial
this study aims to evaluate balance using the biodex balance system among patients with spondylosis, spondylolisthesis, and lumber disc prolapse.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Lumbar spondylosis; defined as degenerative disc disease, osteophyte formation with or without facet joint arthropathy (Natarajan et al., 2021; Christe et al., 2020).
Lumbar spondylolisthesis; defined as anterolisthesis of one vertebral body over another, graded via the Meyerding scale (grade 1 or 2) (Giordan et al., 2023; Chuang et al., 2018).
Lumbar disc prolapse; defined as protrusion, herniation of intervertebral disc (Kang et al., 2016; Hahne et al., 2019).
Age of patients ranges from 35 to 55 years (Albeshri, et.al., 2017)
Disqualifiers
Prior lumbar spine surgery or neurological disorders (e.g., parkinson's, stroke) that may influence balance (soliman et al., 2017).
Fractures of the spine, pelvis or lower extremities, (Karimi et al., 2008).
Leg length discrepancy(Karimi et al., 2008).
Systemic disease such as arthritis, tuberculosis, liver or kidney failure. (Karimi et al., 2008).
Trial design
Design model
Crossover
Treatments tested in this trial
Assessment of balance will be measured by The Biodex Balance System (BBS) which computes Postural Stability key indices: the medial-lateral stability index (MLSI), anterior-posterior stability index
Diagnostic testLow back pain (LBP) is a leading cause of disability worldwide and is often associated with postural and balance impairments. However, limited evidence exists on how these deficits differ among specific types of LBP such as lumbar spondylosis, spondylolisthesis, and disc prolapse. Understanding these variations is crucial for accurate assessment and targeted rehabilitation. Evaluating balance using the Biodex Balance System can help identify the extent of impairment and guide physiotherapists in developing individualized rehabilitation programs that enhance postural control, stability, and functional performance, ultimately improving quality of life and reducing fall risk among LBP patients.
Treatment groups
80 Participants
are divided into 4 treatment groupsGroup A: Group (GI)= will include 20 healthy normal subjects.Active comparator 1 intervention
Group B: Group (GII) will include 20 patients with lumbar spondylosis.Active comparator 1 intervention
Group C: Group (GIII) will include 20 patients with lumbar spondylolisthesis.Active comparator 1 intervention
Group D: Group (GIV) will include 20 patients with lumbar disc prolapse.Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Postural stability ( Overall Stability Index)
Postural stability will be assessed using the Biodex Balance System through the Overall Stability Index (OSI).The OSI reflects the degree of platform sway, with lower values indicating better balance control. Measurements will be taken under six standardized conditions to evaluate both static and dynamic balance performance. These conditions include: Double-Leg, Eyes Open (DLEO) Double-Leg, Eyes Closed (DLEC) Single-Leg, Eyes Open (SLEO) - Dominant Leg Single-Leg, Eyes Closed (SLEC) - Dominant Leg Single-Leg, Eyes Open (SLEO) - Non-Dominant Leg Single-Leg, Eyes Closed (SLEC) - Non-Dominant Leg
Time frame
All postural assessments will be performed for 20 seconds2
Postural Stability: Medial-Lateral Stability Index (MLSI)
The Medial-Lateral Stability Index (MLSI) will be obtained from the Biodex Balance System to assess side-to-side postural control. Higher MLSI values indicate greater medial-lateral sway, while lower values reflect better stability in the frontal plane. the measurement will be in six conditions: Double leg eyes open (DLEO), Double leg eyes closed (DLEC), Single leg eye open (SLEO) Dominant leg, Single leg eye closed (SLEC) Dominant leg, Single leg eye open (SLEO) Non-Dominant leg and Single leg eye closed (SLEC) Non-Dominant leg
Time frame
All postural assessments will be performed for 20 seconds3
postural stability: Anterior-Posterior Stability Index (APSI)
The Anterior-Posterior Stability Index (APSI) will be measured using the Biodex Balance System to evaluate forward-backward postural control. Lower APSI values indicate improved stability in the sagittal plane, whereas higher values reflect increased anterior-posterior sway. the measurement will be in six conditions: Double leg eyes open (DLEO), Double leg eyes closed (DLEC), Single leg eye open (SLEO) Dominant leg, Single leg eye closed (SLEC) Dominant leg, Single leg eye open (SLEO) Non-Dominant leg and Single leg eye closed (SLEC) Non-Dominant leg
Time frame
All postural assessments will be performed for 20 seconds4
Limits of Stability
Limits of Stability will be assessed using the Biodex Balance System to evaluate the participant's ability to intentionally shift their center of gravity toward predefined targets without losing balance. The test measures directional control, reaction time, movement speed, and endpoint accuracy, with higher scores reflecting better dynamic balance and voluntary postural control. the measurement condition will be in Double leg eyes open (DLEO)
Time frame
All postural assessments will be performed for 20 secondsSecondary outcomes
1
Arabic version of Numerical pain rating scale (Ar-NPRS)
The Numerical Rating Scale is used to quantify the intensity of a subjective symptom-most commonly pain-on a 0 to 10 scale. A score of 0 represents no pain or no symptom, while a score of 10 indicates the worst imaginable pain or maximum symptom severity. Higher scores reflect a worse outcome, indicating greater intensity.
Time frame
Periprocedural2
Arabic version of Oswestry disability index (Ar-ODI)
The arabic Oswestry Disability Index is a questionnaire used to assess disability related to low back pain. Scores range from 0 to 100, where 0 indicates no disability and 100 indicates maximum disability. Higher scores represent a worse outcome, reflecting greater functional limitation.
Time frame
PeriproceduralSponsors and contacts
Click on the lead sponsor to view all of their trials.
Cairo University
Lead sponsor
Delta University for Science and Technology
Sponsor institution
Delta University for Science and Technology
Collaborator
Source ClinicalTrials.gov
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