- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07683676
Kinetic Control Training Versus Core Stability Exercises on Proprioception and Spatiotemporal Gait Parameters in Chronic Non-specific Low Back Pain (CNSLBP)
1. juli 2026 opdateret af: Ola Adel Abd Elrazik Ibrahem, Cairo University
This study will be conducted to comapre between kinetic control training versus core stability exercises on proprioception and spatiotemporal gait parameters in chronic non-specific low back pain.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Chronic nonspecific low back pain (CNSLBP) represents a significant public health problem and an economic burden to employers.
It has become one of the most common problems in industrialized societies; it can affect 80% of people and has become the most common cause of functional limitation in individuals younger than 35 years.
Neuromuscular impairments and deficits are a primary contributor to the inception and chronicity of Low back pain with the psychological and social competes.
Specific-oriented retraining has a major effect in modulating biopsychosocial competes severity and peculiarity and crucial for controlling chronic Low back pain.
Interventions targeting neuromuscular impairments of the movement system are the most promising movement control concepts in these Low back pain treatment approaches.Kinetic Control Training (KCT), which focuses on movement control and muscle coordination, has emerged as a potential intervention for addressing the underlying motor control deficits associated with CNSLBP.
Exercises in managing CNSLBP.
For instance, a randomized controlled trial demonstrated that core stability training significantly improved back muscle strength and reduced pain intensity in young adults with chronic non-specific low back pain.
To the best of authors' knowledge, the effect of kinetic control versus core stability training on the spatiotemporal parameters of the gait has not been investigated yet.
So this study will be conducted to investigate this point.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
60
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: ola Adel, phd
- Telefonnummer: 01207003453
- E-mail: adelola191@gmail.com
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Subjects from both sexes diagnosed with chronic non-specific low back pain with uncontrolled movement related to kinetic control concept
- aging range from 18-45 years
- Pain provoked by movement.
- Pain for at least 3 months
- Pain with sufficient intensity (equal to or greater than 4 points on VAS).
Exclusion Criteria:
- History of previous spinal surgery.
- Patients with lumbar spine diseases (for example, disc prolapse or spondylolisthesis).
- Patients with abnormal neurological signs in lower extremities, radicular pain in the lower limb, hip arthrosis, congenital musculoskeletal deformity, female patients with pelvic lesions, and pregnant females.
- Red flag signs include unwanted weight loss, less than three months of symptom persistence, malignancies of the spine, spinal instability due to structural cause, for example: ligamentous sprain or spondylolisthesis.
- Gynaecological problems in females that may cause low back pain include coccydynia and hysterotomy
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Kinetic control group
Twenty patients will receive kinetic control training with conventional physical therapy three times a week for 8 weeks
|
Each patient in the group will be received kinetic control retraining with conventional physical therapy.
For each movement direction, specific control tests will be conducted.
The direction and site of the uncontrolled movement will be evaluated using special tests in accordance with the pain history of the patient.
conventional physical therapy includes Trans-cutaneous electric Nerve Stimulation (TENS), Heat by hot packs
|
|
Eksperimentel: Core stability exercises group
Twenty patients will receive core stability exercises with conventional physical therapy three times a week for 8 weeks
|
conventional physical therapy includes Trans-cutaneous electric Nerve Stimulation (TENS), Heat by hot packs
Core stability exercises include curl up (head and shoulders lifting), bridging exercise with leg elevation, and quadruped with arm and leg lift will be performed with maintaining the lumbar spine neutral.
each patient in that group will be received core stability exercises with conventional physical therapy,
|
|
Aktiv komparator: Conventional physical therapy exercise
twenty patients will receive conventional physical therapy three times a week for 8 weeks
|
conventional physical therapy includes Trans-cutaneous electric Nerve Stimulation (TENS), Heat by hot packs
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
lumber repositioning error (lumbar proprioception)
Tidsramme: up to 8 weeks
|
The iPhone® application will be used to assess lumbar repositioning error.
It will be placed vertically, halfway between the anterior superior and PSIS, just above the iliac crest, and fastened with a belt.
The initial location and the inclination of the inclinometer were both fixed at 0°.
There was a 0 to 30° range of motion (ROM).
The assessor gently guided the individual to a 30° flexion and instructed them to hold this posture for ten seconds.
After then, the participant actively went back to their starting location and subsequently did it three times.
|
up to 8 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
pain intensity
Tidsramme: up to 8 weeks
|
visual analogue scale will be used to assess pain intensity.t
consists of a 100-mm line with descriptive anchors representing extremes at each end, such as "no pain" and "worst pain imaginable.
|
up to 8 weeks
|
|
gait speed
Tidsramme: up to eight weeks
|
Using Kinovea (an open-source software) (version 0.9.5), a freeware motion analysis software will be used to retrieve all of the videos from the Sony Video camera.
normal, healthy gait speed for adults is generally between 1.0 m/s to 1.5 m/s.
|
up to eight weeks
|
|
cadence
Tidsramme: up to eight weeks
|
Cadence in gait is the rate at which steps are taken during locomotion, measured as steps per minute.Using Kinovea (an open-source software) (version 0.9.5), a freeware motion analysis software will be used to retrieve all of the videos from the Sony Video camera.
A healthy adult's normal walking cadence typically ranges between 100 to 120 steps per minute.
|
up to eight weeks
|
|
stride and step time
Tidsramme: up to eight weeks
|
Stride time is the total time taken to complete one full gait cycle.
Step time is the time it takes to complete a single step.Using Kinovea (an open-source software) (version 0.9.5), a freeware motion analysis software will be used to retrieve all of the videos from the Sony Video camera.
Normal walking gait for a healthy adult at a comfortable pace typically features a stride time of about 1.15 seconds and a step time of about 0.5 to 0.6 seconds
|
up to eight weeks
|
|
stride and step length
Tidsramme: up to eight weeks
|
Step length is the distance between the placement of one foot and the next placement of the opposite foot.
Stride length, conversely, covers the distance of two consecutive steps.
Using Kinovea (an open-source software) (version 0.9.5), a freeware motion analysis software will be used to retrieve all of the videos from the Sony Video camera.
A normal walking step length 58 to 76 cm.
A stride length averaging 52 to 60 inches.
|
up to eight weeks
|
|
COG vertical displacement
Tidsramme: up to eight weeks
|
Vertical displacement of the Center of Gravity (CoG) typically refers to the rhythmic, up-and-down movement of the body's mass center during the human gait cycle.
In a normal walking step, this vertical movement ranges to about 5 cm, helping conserve overall energy and maintain smooth motion.Using Kinovea (an open-source software) (version 0.9.5), a freeware motion analysis software will be used to retrieve all of the videos from the Sony Video camera.
|
up to eight weeks
|
|
life disability
Tidsramme: up to eight weeks
|
The WHOQOL-BREF will be used to assess life disability.
it is a 26-item survey evaluating Quality of Life (QoL) across four domains: Physical, Psychological, Social Relationships, and Environment.
Higher scores in each domain indicate a better perception of QoL
|
up to eight weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
10. juli 2026
Primær færdiggørelse (Anslået)
1. maj 2027
Studieafslutning (Anslået)
1. maj 2027
Datoer for studieregistrering
Først indsendt
8. juni 2026
Først indsendt, der opfyldte QC-kriterier
1. juli 2026
Først opslået (Faktiske)
6. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- P.T.REC/012/006359
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .