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Low Back PainBiodexNCT07242976

Evaluation of Balance Using the Biodex Balance System Among Different Subcategories of Low Back Pain

A study testing 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 in people with Low Back Pain and Spondylolisthesis, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

this study aims to evaluate balance using the biodex balance system among patients with spondylosis, spondylolisthesis, and lumber disc prolapse. Read more about this study

Who is it for?
Ages 35 to 55 yearsHealthy volunteers can take part
What is being tested?
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
Could I receive a placebo?
No, everyone receives an active treatment
How many people
104 participants
Where
1 siteEgypt
Study dates
1 Dec 2025to 3 May 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Diagnosis of chronic low back pain (≥3 months duration) (Ge et al., 2021). Referred from orthopedic surgeons with confirmed diagnosis of lumbar spondylosis, spondylolisthesis or lumber disc prolapse affecting L4-L5 or L5 S1( Hlaing et al., 2020) depending on imaging findings (MRI, CT or X-ray scan within the last 6 months):
  • 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)
  • Both genders will be included in the study
Show all 9Show fewer
  • Pain intensity: ≥ 4/10 on a numerical pain rating scale (Thong et al., 2011).
  • BMI ranged from (18.5-29.9 kg/m²) (Karimi et al., 2008; Soliman et al., 2017).
  • Healthy subjects are healthy volunteers and without any Musculoskeletal disorders (Karimi et al., 2008).

Who cannot join

  • The following patients will be excluded from the study patients with:
  • 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).
  • Patients with chronic non-specific low back pain.
  • Patients exhibiting red flag symptoms such as urinary or fecal incontinence, saddle anesthesia, progressive motor deficits (e.g., foot drop), or other signs of serious neurological compromis (Ruhe et al., 2011).
  • Participants experiencing low back pain with pain radiating distaly below the level of knee (Hlaing et al., 2020).

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Faculty of Physical Therapy Delta University

    Gamasa

Other trials in Egypt

About this study

this study aims to evaluate balance using the biodex balance system among patients with spondylosis, spondylolisthesis, and lumber disc prolapse.

Read the detailed description

Low back pain is one of the most common causes of disability globally . While postural balance impairments have been widely documented in individuals with low back pain, there is limited understanding of how these impairments vary across specific subcategories of specific low back pain. Low back pain is generally categorized into non specific and specific types.

Non-specific LBP approximately accounts for 85-90% of all low back pain cases (Hartvigsen et al., 2018). In contrast, specific low back pain arises from a recognizable pathology such as structural abnormalities. The most common causes of specific low back pain are lumbar spondylosis, spondylolisthesis, and lumbar disc prolapse. Lumbar spondylosis has a prevalence of 74% in individuals over 60 years confirmed with radiographic findings. Spondylolisthesis affects approximately 6-11.5% of adults , lumbar disc prolapse accounts for 2-5% of all low back pain cases.

Balance deficiency among patients with spondylosis, spondylolisthesis and lumber disc prolapse was reported in literature by different objective assessment tools. Individuals with low back pain exhibit measurable deficits in balance and postural stability compared to healthy controls . Also, the chronicity of low back pain affects both static and dynamic balance.

Assessment and detection of balance deficiency among patients with spondylosis, spondylolisthesis and lumber disc prolapse will allow physical therapists to design individualized rehabilitation programs. Improve understanding of interventions focusing on core stabilization, proprioceptive retraining and dynamic balance. This may improve postural control, enhance gait performance, reduce fall risk and support better functional outcomes in daily activities.

Thus, there was a need to study the difference in balance using the biodex balance system among patients with spondylosis, spondylolisthesis and lumber disc prolapse. The current study may provide a more conclusive insight in evaluation and treatment of patients with low back pain.

Being tested
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
Keywords
biodex, balance, subcategories of low back pain
Medical subject headings
Low Back Pain, Spondylolisthesis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 indexDiagnostic test

    Also called Arabic Numerical Rating Scale, Arabic version of Oswestry disability index (Ar-ODI)

    Low 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.

Study groups in NCT07242976
Study groupRoleWhat they receive
Group (GI)= will include 20 healthy normal subjects.Active comparatorAssessment 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 (APSI), and overall stability index (OSI). Each index is further measured in four outcomes: Double leg eyes open (DLEO), Double leg eyes closed (DLEC), Single leg eye open (SLEO) for both legs and Single leg eye closed (SLEC) for both legs. Additionally Biodex Balance Systen (BBS) will assess limit of stability in one outcome: Double leg eyes open (DLEO).
Receives: Diagnostic Test: 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
Group (GII) will include 20 patients with lumbar spondylosis.Active comparatorAssessment 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 (APSI), and overall stability index (OSI). Each index is further measured in four outcomes: Double leg eyes open (DLEO), Double leg eyes closed (DLEC), Single leg eye open (SLEO) for both legs and Single leg eye closed (SLEC) for both legs. Additionally Biodex Balance Systen (BBS) will assess limit of stability in one outcome: Double leg eyes open (DLEO).
Receives: Diagnostic Test: 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
Group (GIII) will include 20 patients with lumbar spondylolisthesis.Active comparatorAssessment 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 (APSI), and overall stability index (OSI). Each index is further measured in four outcomes: Double leg eyes open (DLEO), Double leg eyes closed (DLEC), Single leg eye open (SLEO) for both legs and Single leg eye closed (SLEC) for both legs. Additionally Biodex Balance Systen (BBS) will assess limit of stability in one outcome: Double leg eyes open (DLEO).
Receives: Diagnostic Test: 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
Group (GIV) will include 20 patients with lumbar disc prolapse.Active comparatorAssessment 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 (APSI), and overall stability index (OSI). Each index is further measured in four outcomes: Double leg eyes open (DLEO), Double leg eyes closed (DLEC), Single leg eye open (SLEO) for both legs and Single leg eye closed (SLEC) for both legs. Additionally Biodex Balance Systen (BBS) will assess limit of stability in one outcome: Double leg eyes open (DLEO).
Receives: Diagnostic Test: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: All postural assessments will be performed for 20 seconds

  2. 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

    Measured: All postural assessments will be performed for 20 seconds

  3. 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

    Measured: All postural assessments will be performed for 20 seconds

  4. 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)

    Measured: All postural assessments will be performed for 20 seconds

Secondary outcomes (2)
  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.

    Measured: Periprocedural

  2. 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.

    Measured: Periprocedural

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2025
  2. Study start1 Dec 2025
  3. Primary completion3 Apr 2026
  4. Study completion3 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Crossover
Model description
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 (APSI), and overall stability index (OSI). Each index is further measured in four outcomes: Double leg eyes open (DLEO), Double leg eyes closed (DLEC), Single leg eye open (SLEO) for both legs and Single leg eye closed (SLEC) for both legs. Additionally Biodex Balance Systen (BBS) will assess limit of stability in one outcome: Double leg eyes open (DLEO).
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
104 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07242976
Sponsor's protocol ID
BIODEX BALANCE SYSTEM
Acronym
Biodex
Status last verified
Oct 2026
First submitted
14 Nov 2025
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing 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 in people with Low Back Pain and Spondylolisthesis, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postural stability ( Overall Stability Index) (time frame: All postural assessments will be performed for 20 seconds). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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