EFFICACY OF ARTIFICIAL INTELLIGENCE DRIVEN PROGRAM VERSUS TRADITIONAL PHYSICAL THERAPY PROGRAM IN PATIENTS WITH LOW BACK DYSFUNCTION (AI-LBD)

August 5, 2026 updated by: Dalia Ashraf Mohamed Youssef, Cairo University

Efficacy of an Artificial Intelligence-Driven Program Versus a Traditional Physical Therapy Program in Patients With Low Back Dysfunction

Low back dysfunction is one of the most common musculoskeletal disorders and is associated with pain, disability, and reduced quality of life. Artificial intelligence (AI) has emerged as a promising tool to support personalized rehabilitation by improving exercise prescription, monitoring adherence, and providing real-time feedback. This randomized controlled trial aims to compare the effectiveness of an AI-driven rehabilitation program with a traditional physical therapy program in patients with low back dysfunction. Primary outcomes include pain intensity, functional disability, and quality of life. The findings may provide evidence regarding the role of AI-assisted rehabilitation in improving clinical outcomes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is a prospective randomized controlled trial designed to evaluate the efficacy of an artificial intelligence-driven rehabilitation program compared with a traditional physical therapy program in patients with low back dysfunction. Eligible participants will be randomly allocated into two groups. The experimental group will receive an AI-driven rehabilitation program, while the control group will receive a standardized traditional physical therapy program. Clinical outcomes will be assessed before and after the intervention using validated outcome measures for pain, functional disability, quality of life, and other variables specified in the study protocol. The study aims to determine whether integrating artificial intelligence into rehabilitation provides superior clinical outcomes compared with conventional physical therapy.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypt
        • Faculty of physical therapy, Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults aged 18-45 years.
  • Male or female participants.
  • Clinical diagnosis of low back dysfunction by a physiotherapist or physician.
  • Symptoms lasting more than 3 months.
  • Ability to participate in physical therapy or use AI-based rehabilitation tools.
  • Willingness to comply with the study protocol and provide written informed consent.

Exclusion Criteria:

  • Recent spinal injury or spinal surgery.
  • Previous spinal surgery within the last 6 months.
  • Severe neurological disorders (e.g., multiple sclerosis or Parkinson's disease).
  • Chronic conditions that significantly limit mobility (e.g., advanced arthritis).
  • Current use of strong opioid analgesics.
  • Severe psychiatric disorders.
  • Inability to use or access the required technology for the AI intervention.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: AI-Driven Rehabilitation
Participants will receive an artificial intelligence-driven rehabilitation program including personalized exercise prescription, progression, and monitoring according to the study protocol.
Other: AI-Driven Rehabilitation Program
A personalized rehabilitation program guided by artificial intelligence, including individualized exercise prescription and progression.
Active Comparator: Traditional Physical Therapy
Participants will receive a standardized traditional physical therapy rehabilitation program according to the study protocol.
Other: Traditional Physical Therapy Program
A conventional physical therapy rehabilitation program delivered according to the study protocol

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain Intensity
Time Frame: Baseline and immediately post intervention 6 weeks of treatment.
Pain intensity measured using the Visual Analogue Scale (VAS), a 10-cm self-reported pain scale ranging from 0 (no pain) to 10 (worst imaginable pain).
Baseline and immediately post intervention 6 weeks of treatment.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Functional Performance
Time Frame: Baseline and after 6 weeks.
Functional performance measured using the Back Performance Scale (BPS). The total score ranges from 0 to 15, with higher scores indicating greater functional limitation.
Baseline and after 6 weeks.
Cost-effectiveness
Time Frame: After completion of the 6-week intervention.
Cost-effectiveness assessed using the Incremental Cost-Effectiveness Ratio (ICER), based on total costs and clinical effectiveness of the AI-driven and traditional physical therapy programs,including direct medical costs, intervention-related costs, and healthcare utilization costs.
After completion of the 6-week intervention.
Lumbar Range of Motion
Time Frame: Baseline and after 6 weeks.
Lumbar range of motion assessed using the Back Range of Motion (BROM II) device measuring lumbar flexion, extension, lateral flexion, and rotation.
Baseline and after 6 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AI-LBD-20260803-1995-DA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be publicly shared to protect participant confidentiality and privacy.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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