NCT07749833

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
68

participants targeted

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

Timeline
5mo left

Started Aug 2026

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

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Study Timeline

Key milestones and dates

Study Progress4%
Aug 2026Jan 2027

Study Start

First participant enrolled

August 1, 2026

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 6, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

August 6, 2026

Status Verified

August 1, 2026

Enrollment Period

4 months

First QC Date

August 3, 2026

Last Update Submit

August 3, 2026

Conditions

Keywords

Artificial IntelligenceLow Back DysfunctionLow Back PainPhysical TherapyRehabilitationExercise TherapyAI-Driven RehabilitationMusculoskeletal RehabilitationRandomized Controlled TrialPersonalized Rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Pain Intensity

    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 Outcomes (3)

  • Functional Performance

    Baseline and after 6 weeks.

  • Cost-effectiveness

    After completion of the 6-week intervention.

  • Lumbar Range of Motion

    Baseline and after 6 weeks.

Study Arms (2)

AI-Driven Rehabilitation

EXPERIMENTAL

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

Traditional Physical Therapy

ACTIVE COMPARATOR

Participants will receive a standardized traditional physical therapy rehabilitation program according to the study protocol.

Other: Traditional Physical Therapy Program

Interventions

A personalized rehabilitation program guided by artificial intelligence, including individualized exercise prescription and progression.

AI-Driven Rehabilitation

A conventional physical therapy rehabilitation program delivered according to the study protocol

Traditional Physical Therapy

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy, Cairo University

Cairo, Cairo Governorate, Egypt

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Dalia A Youssef, MSc, PT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to one of two parallel groups: an AI-driven rehabilitation program or a traditional physical therapy program.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer and PhD Candidate

Study Record Dates

First Submitted

August 3, 2026

First Posted

August 6, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

August 6, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

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

Locations