- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07936409
Effect of AI-Based Exercises on Pain, Function, Kinesiophobia, and Trunk Motor Control in Chronic Low Back Pain
Effect of AI Based Exercises on Pain, Function, Kinesophobia and Trunk Motor Control in Treatment of Chronic Non-Specific Low Back Pain
This study compares the effect of an artificial intelligence (AI)-generated exercise program with a traditional core stabilization exercise program in people with chronic non-specific low back pain.
Participants are assigned by chance to 1 of 2 groups:
- Group 1 receives an AI-generated therapeutic exercise protocol.
- Group 2 receives a traditional trunk stabilization exercise program supervised by a physical therapist.
Participants in both groups perform exercise sessions 3 times per week for 4 weeks.
The main goals are to find out if the AI-generated exercise program leads to:
- Better deep abdominal muscle control measured with a pressure biofeedback unit
- Reduced low back pain
- Improved daily physical function
- Less fear of movement
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Giza Governorate
-
Cairo, Giza Governorate, Egitto, 12613
- Faculty of physical therapy - Cairo university
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Male and female participants aged between 20 and 35 years.
- Clinical diagnosis of CNSLBP persisting for more than 12 weeks, with a pain intensity score greater than 3 on the Visual Analog Scale (VAS).
- Demonstrated deficits in trunk motor control as assessed by Prone Instability Test (PIT).
- Patients with BMI < 30.
Exclusion Criteria:
- History of spinal or abdominal surgery.
- Structural spinal abnormalities (e.g., spondylolisthesis, spinal stenosis, or scoliosis).
- Neurological disorders affecting trunk control or balance.
- Acute injury or flare-up of back pain within the past month.
- Pregnancy.
- Participation in another physical therapy or rehabilitation program during the study period.
- Any contraindication to physical activity as per medical screening.
- Inability to understand and follow verbal and written instructions.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Experimental group
This group will receive artificial intelligence (AI) based exercises specifically designed for chronic non-specific low back pain for 4 weeks. |
Participants will perform a set of therapeutic exercises specifically generated by artificial intelligence (AI) algorithms to target trunk stabilization and motor control. The program consists of exercises tailored for chronic non-specific low back pain, performed for 40 minutes per session, 3 times a week, for a total duration of 4 weeks. All sessions will be conducted under the supervision of a physical therapist to ensure proper technique. |
|
Comparatore attivo: Control Group
This group will receive conventional trunk stabilization exercises supervised by a physical therapist for 4 weeks. |
Participants in the control group will perform a conventional trunk stabilization exercise program. The exercises are designed to improve core stability and motor control, conducted under the direct supervision of a physical therapist. The program consists of 40-minute sessions, 3 times a week, for a total of 4 weeks. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change from Baseline in Trunk Motor Control at 4 Weeks.
Lasso di tempo: Baseline and after 4 weeks of intervention
|
Assessed using a Pressure Biofeedback Unit (Stabilizer) in the prone position to measure deep abdominal muscle activation (transversus abdominis) during the abdominal drawing-in maneuver (ADIM). Baseline pressure is set at 70 mmHg, and pressure reduction is recorded in mmHg (target reduction: 4 to 10 mmHg). Higher ability to achieve and maintain target reduction indicates better motor control. |
Baseline and after 4 weeks of intervention
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change from Baseline in Pain Intensity at 4 Weeks
Lasso di tempo: Baseline and after 4 weeks of intervention
|
A 10-cm horizontal Visual Analogue Scale (VAS) used to measure low back pain intensity, ranging from 0 (no pain) to 10 (worst imaginable pain). Lower scores indicate less pain. |
Baseline and after 4 weeks of intervention
|
|
Change from Baseline in Functional Disability at 4 Weeks
Lasso di tempo: Baseline and after 4 weeks of treatment.
|
The Arabic version of the Oswestry Disability Index (ODI), a 10-item self-report questionnaire assessing the impact of low back pain on activities of daily living. Total scores range from 0% (no disability) to 100% (maximum disability). Lower percentage scores indicate better functional performance. |
Baseline and after 4 weeks of treatment.
|
|
Change from Baseline in Fear-Avoidance Beliefs at 4 Weeks
Lasso di tempo: Baseline and after 4 weeks of treatment.
|
The Arabic version of the Fear-Avoidance Beliefs Questionnaire (FABQ), consisting of 16 items divided into physical activity and work subscales. Scored on a 7-point Likert scale (0 = completely disagree to 6 = completely agree), with higher scores indicating greater fear-avoidance beliefs. |
Baseline and after 4 weeks of treatment.
|
|
Change from Baseline in Dynamic Trunk Stability at 4 Weeks
Lasso di tempo: Baseline and after 4 weeks of intervention
|
Assesses the ability to control lumbopelvic movement during active limb motion in supine across 5 progressive levels using the Sahrmann Core Stability Test (Levels 1 to 5). The highest level successfully completed without lumbar movement is recorded. Higher levels indicate better dynamic stability. |
Baseline and after 4 weeks of intervention
|
|
Lumbar Segmental Instability Status at 4 Weeks
Lasso di tempo: Baseline and after 4 weeks of intervention
|
A clinical screening test used to assess lumbar segmental instability and motor control using the Prone Instability Test (PIT). Recorded as either positive (reduction of pain when lifting legs) or negative (no reduction of pain). |
Baseline and after 4 weeks of intervention
|
Collaboratori e investigatori
Sponsor
Investigatori
- Cattedra di studio: Salwa F Abdelmajeed, Ph.D. (Professor), Cairo University
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- P.T.REC/012/006291
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Individual participant data will not be shared publicly to maintain participant confidentiality and adhere to institutional data governance policies. Aggregated study results will be made available upon reasonable request to the corresponding author.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .