- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07780435
Whole-body Vibration Versus Gravity Force Stimulation on Postural Stability in Children With Duchene Muscular Dystrophy
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Duchenne Muscular Dystrophy (DMD) is a progressive X-linked neuromuscular disorder characterized by muscle fiber degeneration due to mutations in the dystrophin gene (Birnkrant et al., 2018). As muscle weakness advances, children with DMD experience impaired postural control, reduced balance function, and increased risk of falls, all of which significantly contribute to limitations in daily activities and loss of independence (Ricotti et al., 2016). Early therapeutic interventions are essential to slow functional decline and promote motor stability for as long as possible.
Whole-body vibration (WBV) has emerged as a potential modality to enhance neuromuscular activation, proprioception, and balance in individuals with muscle weakness or neurological impairments. Studies suggest that low-frequency WBV can improve muscle spindle sensitivity, postural reactions, and balance performance in pediatric and neuromuscular populations (Brunetti et al., 2015; Saquetto et al., 2015). Although research involving children with DMD is limited, preliminary evidence indicates that WBV may transiently enhance motor function without excessive muscle strain.
Gravity-force stimulation (GFS)-often delivered through tilt platforms, vertical acceleration devices, or graded gravitational loading-has been proposed as another means to stimulate proprioceptive pathways and increase postural control. GFS can enhance sensory input from weight-bearing structures and may promote improved equilibrium response strategies in children with neuromotor impairments (Bates & Hanson, 2019). However, its application specifically in DMD remains under-studied, and direct comparisons with WBV have not been adequately explored.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Giza Governorate
-
Giza, Giza Governorate, Egypt, 11432
- Cairo University
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Children diagnosed with Duchenne Muscular Dystrophy (DMD).
- Age between 6 and 10 years.
- Lower extremity and trunk muscle strength graded at least 3+, based on the manual muscle testing criteria.
- Ability to move the upper and lower limbs within functional limits without severe joint restriction.
- Ability to walk independently without assistive devices, corresponding to Levels I and II of the Ambulation Function Classification System for DMD (AFCSD).
Exclusion Criteria:
- Presence of cardiopulmonary dysfunction or congenital or acquired skeletal abnormalities that may interfere with participation.
- History of lower-limb surgical procedures.
- Neurological conditions affecting balance or gait, or evidence of poor motor development not attributable to DMD.
- Behavioral disorders that would prevent cooperation during assessment or intervention sessions.
- Overweight status, defined as a body mass index (BMI) greater than 25 kg/m²
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: whole body vibration group
whole body vibration intervention
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we use vibrating platform •
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Eksperimentell: force gravity stimulation group
force gravity stimulation intervention
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Thirty children received: • Gravity-Force Stimulation (GFS), which included:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
abdominal muscle thickness
Tidsramme: 3 months
|
measure the abdominal muscle thickness
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3 months
|
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postural stability
Tidsramme: 3 months
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• BIODEX MEDICAL SYSTEM used for assessment of postural stability and balance
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3 months
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Mostafa S. Ali, Cairo University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- P.T.REC/012/006366
Plan for individuelle deltakerdata (IPD)
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