- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Giza Governorate
-
Cairo, Giza Governorate, Ägypten, 12613
- Faculty of physical therapy - Cairo university
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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. |
|
Aktiver Komparator: 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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change from Baseline in Trunk Motor Control at 4 Weeks.
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change from Baseline in Pain Intensity at 4 Weeks
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienstuhl: Salwa F Abdelmajeed, Ph.D. (Professor), Cairo University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- P.T.REC/012/006291
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
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.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .