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

2026年8月5日 更新者：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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

68

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 埃及
    • Cairo Governorate
      • Cairo、Cairo Governorate、埃及
        • Faculty of Physical Therapy, Cairo University

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：AI-Driven Rehabilitation
Participants will receive an artificial intelligence-driven rehabilitation program including personalized exercise prescription, progression, and monitoring according to the study protocol.
其他：AI-Driven Rehabilitation Program
A personalized rehabilitation program guided by artificial intelligence, including individualized exercise prescription and progression.
有源比较器：Traditional Physical Therapy
Participants will receive a standardized traditional physical therapy rehabilitation program according to the study protocol.
其他：Traditional Physical Therapy Program
A conventional physical therapy rehabilitation program delivered according to the study protocol

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Pain Intensity
大体时间：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.

次要结果测量

结果测量
措施说明
大体时间
Functional Performance
大体时间：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
大体时间：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
大体时间：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.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Cairo University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月1日

初级完成 (估计的)

2026年12月1日

研究完成 (估计的)

2027年1月1日

研究注册日期

首次提交

2026年8月3日

首先提交符合 QC 标准的

2026年8月3日

首次发布 (实际的)

2026年8月6日

研究记录更新

最后更新发布 (实际的)

2026年8月7日

上次提交的符合 QC 标准的更新

2026年8月5日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • AI-LBD-20260803-1995-DA

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

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

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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