NCT07242976

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 21, 2025

Completed
10 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2026

Completed
Last Updated

November 21, 2025

Status Verified

November 1, 2025

Enrollment Period

2 months

First QC Date

November 14, 2025

Last Update Submit

November 19, 2025

Conditions

Low Back PainSpondylolisthesisSpondylosis LumbarBalance Assessment

Keywords

biodexbalancesubcategories of low back pain

Outcome Measures

Primary Outcomes (4)

  • 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

    All postural assessments will be performed for 20 seconds

  • 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

    All postural assessments will be performed for 20 seconds

  • 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

    All postural assessments will be performed for 20 seconds

  • 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)

    All postural assessments will be performed for 20 seconds

Secondary Outcomes (2)

  • Arabic version of Numerical pain rating scale (Ar-NPRS)

    Periprocedural

  • Arabic version of Oswestry disability index (Ar-ODI)

    Periprocedural

Study Arms (4)

Group (GI)= will include 20 healthy normal subjects.

ACTIVE COMPARATOR

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).

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 COMPARATOR

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).

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 COMPARATOR

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).

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 COMPARATOR

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).

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

Interventions

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

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.

Also known as: Arabic Numerical Rating Scale, Arabic version of Oswestry disability index (Ar-ODI)
Group (GI)= will include 20 healthy normal subjects.Group (GII) will include 20 patients with lumbar spondylosis.Group (GIII) will include 20 patients with lumbar spondylolisthesis.Group (GIV) will include 20 patients with lumbar disc prolapse.

Eligibility Criteria

Age35 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy Delta University

Gamasa, Egypt

Location

MeSH Terms

Conditions

Low Back PainSpondylolisthesis

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSpondylolysisSpondylosisSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Enas F Yousef, Professor of Physical Therapy

    Physical Therapy for Musculoskeletal Disorders and Its Surgery, Faculty of Physical Therapy, Cairo University

    PRINCIPAL INVESTIGATOR

  • MOAAZ R RIYAD, Lecturer

    Lecturer of Department of Physical Therapy for Musculoskeletal Disorders and Its Surgery

    STUDY DIRECTOR

Central Study Contacts

Muhammed E Abulftouh

CONTACT

+201023292028ftoh1996@gmail.com

Rewan M Aloush

CONTACT

+201024232512rewan.aloush@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Demonstrator at orthopedic department faculty of physical therapy delta university

Study Record Dates

First Submitted

November 14, 2025

First Posted

November 21, 2025

Study Start

December 1, 2025

Primary Completion

February 3, 2026

Study Completion

February 3, 2026

Last Updated

November 21, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)