- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07804836
Investigation of Muscle Activity With sEMG, Surface Topography and Radiographic Changes of Paraspinal Muscles in Individuals With Adolescent Idiopathic Scoliosis.
Investigation of Muscle Activity, Surface Topography and Radiographic Changes of Paraspinal Muscles in Individuals With Adolescent Idiopathic Scoliosis.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
This study was designed to examine paraspinal muscle activity, surface topography, and radiographic characteristics in adolescents with idiopathic scoliosis. The study plans to include adolescents aged 10-18 years diagnosed with idiopathic scoliosis, as well as healthy volunteers matched for age and gender.
Participants will be divided into three groups: adolescents with idiopathic scoliosis who wear a brace, adolescents with idiopathic scoliosis who do not wear a brace, and a healthy control group. A total of 45 participants are planned to be included in the study, with 15 participants in each group.
As part of the study, participants' demographic information will be recorded. Muscle activity in the paraspinal muscles will be assessed using surface electromyography (sEMG). Body surface topography will be assessed using an Artec Eva 3D scanner. Posture analysis will be performed, and spinal curvature will be assessed using the Cobb angle based on existing radiographic images. Quality of life will be determined using the Scoliosis Research Society-22 (SRS-22) questionnaire.
The measurement results obtained will be compared across groups, and the relationships between muscle activity, surface topography, postural characteristics, radiographic parameters, and quality of life will be evaluated.
As part of this study, participants will not receive any treatment or rehabilitation interventions; measurements will be taken to assess their current clinical and physical characteristics.
Undersøgelsestype
Tilmelding (Anslået)
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
- Be between the ages of 10 and 18
- Have been diagnosed with adolescent idiopathic scoliosis
- Be able to stand independently
- Sign the informed consent form
- Have no spinal deformity (for the control group)
- History of neurological disease
- History of spinal surgery
- Presence of congenital or traumatic scoliosis
- Presence of orthopedic or rheumatological conditions that could affect the measurements
- Inability to cooperate during the measurements
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Study Participants
The study participants include adolescents with adolescent idiopathic scoliosis, including individuals who use a brace and those who do not use a brace, as well as healthy control individuals who meet the eligibility criteria.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Paraspinal Muscle Activity
Tidsramme: Baseline (single assesment)
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Paraspinal muscle activity will be assessed using surfaces electromyography (sEMG) in adolescents with adolescent idiopathic scoliosis and healthy controls.
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Baseline (single assesment)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Surface Topography
Tidsramme: Baseline (single assesment)
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Surface topography will be assessed to evaluate trunk surface characteristics in adolescents with adolescent idiopathic scoliosis and healthy controls.
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Baseline (single assesment)
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Radiographic Parameters
Tidsramme: Baseline (single assesment)
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Radiographic parameters will be evaluated to assess spinal alignment in adolescents with adolescent idiopathic scoliosis.
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Baseline (single assesment)
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- Paraspinal muscles for AIS
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