- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07599267
Effect of Reciprocal Electrical Stimulation on Balance and Quality of Life in Hemiparetic CP
Effect of Reciprocal Neuromuscular Electrical Stimulation on Balance and Quality of Life in Children With Hemiparesis
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Neuromuscular Electrical Stimulation is widely used to reduce spasticity and strengthen weak muscles.
Reciprocal electrical stimulation ( RES),which mimic natural agonist-antagonist muscle activation , is a promising too for neuromuscular re-education.
RES has been studied for knee stability in diplegic CP and ankle control in adults but its effect on static and dynamic balance in hemiparetic CP remain unexplored . so this study may be a guide in management of balance problems in children with hemiparesis
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- age range from 6 to10 years .
- spasticity level 1 , 1+ in lower limb muscles according to Modified Ashworth Scale.
- Gross Motor Function Classification System (GMFCS) level 1.
- Able to follow instructions.
Exclusion Criteria:
- Affections of musculoskeletal system including fixed contractures.
- Visual , auditory , vestibular ,sensory disorders or cerebellar disease .
- Botox injection in the last 6 months in gastrocnemius
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: a group of hemiparetic children their balance is disturbed
children diagnosed with hemiparetic CP will receive reciprocal electrical stimulation in combination with neurodevelopmental approach directed toward inhibiting abnormal muscle tone and abnormal reflexes and facilitation of postural control through reflex inhibiting positions using proximal and distal key points of control.
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Mode (A) is selected to apply reciprocal neuromuscular electrical stimulation
Andre navne:
Andre navne:
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Sham-komparator: children diagnosed with hemiparetic CP
neurodevelopmental approach directed toward inhibiting abnormal muscle tone and abnormal reflexes and facilitation of postural control through reflex inhibiting positions using proximal and distal key points of control.
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Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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balance change measured by humac balance system
Tidsramme: 3 monthes
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the ability to maintain a stable posture and preserve it in counter gravity position
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3 monthes
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quality of life change xby Egyptian quality of life questionnaire
Tidsramme: 3 months
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change in social, psychological and physical domains
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3 months
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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
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- cairo2025
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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produkt fremstillet i og eksporteret fra U.S.A.
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