NCT06030960

Brief Summary

To our knowledge, no studies have better investigated the effect of Core Stabilization Exercises using VR on ankle and trunk proprioception in patients with CLBP and in turn on postural stability.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

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

September 3, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 11, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

October 25, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 13, 2025

Completed
Last Updated

June 29, 2025

Status Verified

June 1, 2025

Enrollment Period

10 months

First QC Date

September 3, 2023

Last Update Submit

June 25, 2025

Conditions

Low Back Pain

Keywords

LBPPsychological effectsInterventionVirtual Realitypostural stabilitybalancepainCOP

Outcome Measures

Primary Outcomes (2)

  • Postural stability

    Centre of Pressure (CoP) movements will be tracked by a multi-sensory platform + Body Weight Balance (static):

    12 weeks

  • Proprioception

    Ankle and Trunk Joint Position Sense (JPS)

    12 weeks

Secondary Outcomes (4)

  • Pain Intensity

    12 weeks

  • Pain Self-Efficacy Questionnaire (PSEQ-Ar)

    12 weeks

  • Activities-specific Balance Confidence (ABC)

    12 weeks

  • Pain Catastrophizing Scale

    12 weeks

Study Arms (2)

Group 1

EXPERIMENTAL

Patients with Chronic Low Back Pain (CLBP) who will receive Virtual Reality (VR) stabilization exercises, regular stabilization exercises and patient instructions and education

Device: Virtual Reality (VR)Other: Regular ExercisesOther: patient instructions and education

Group 2

ACTIVE COMPARATOR

Patients with Chronic Low Back Pain (CLBP) who will receive regular stabilization exercises and patient instructions and education

Other: Regular ExercisesOther: patient instructions and education

Interventions

Virtual Reality (VR)DEVICE

Virtual Reality (VR) Stabilization Exercises

Also known as: Exergames
Group 1
Regular ExercisesOTHER

Regular Stabilization Exercises

Group 1Group 2
patient instructions and educationOTHER

a unified form of patient instructions and education in regards of LBP

Group 1Group 2

Eligibility Criteria

Age25 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients in Group 1 and Group 2 will be included if they:
  • Are adults between 25 and 59 years of age.
  • Have LBP for longer than 3 months.
  • Are not currently undergoing medication or conservative treatment.

You may not qualify if:

  • Patients in these two groups will be excluded if they have:
  • Nerve root manifestations (such as referred symptoms of radiating pain below the knee or paresthesia during the straight leg raise test),
  • Systematic or visceral disease,
  • Ankylosing spondylitis, Spondylolysis and Spondylolisthesis,
  • Vestibular dysfunctions,
  • Body mass index (BMI) ≥ 30 kg/m2,
  • Lower extremity injury within the past month,
  • Concussion,
  • Psychiatric, cardiovascular or musculoskeletal disorders,
  • Vision problems,
  • Vertebral fracture,
  • Spinal Stenosis,
  • Previous spinal surgery,
  • Present pregnancy,
  • Scoliosis,
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dammam Medical Complex

Dammam, Eastern Province, Saudi Arabia

Location

MeSH Terms

Conditions

Low Back PainPain

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Back PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Ali AlShami, PhD

    alshami@iau.edu.sa

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Rehabilitation Sciences PhD Student

Study Record Dates

First Submitted

September 3, 2023

First Posted

September 11, 2023

Study Start

October 25, 2023

Primary Completion

August 15, 2024

Study Completion

May 13, 2025

Last Updated

June 29, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

SA(1)