- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07686809
Effect of Lower Extremity Modified Constraint-induced Movement Therapy on Locomotion in Children With Hemiplegia
2. juli 2026 oppdatert av: Mohamed Ali Elsayed Taha, Cairo University
- To determine the effect of modified constraint-induced movement therapy on spatial and temporal gait parameters in children with hemiplegia.
- To determine the effect of modified constraint-induced movement therapy on functional mobility in children with hemiplegia.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Detaljert beskrivelse
Children with spastic hemiplegic cerebral palsy experience longer gait cycles, slower walking speeds, and longer support phases compared to healthy children, with substantial joint angle differences noted during ground contact and stride buffering.
Although most can achieve independent walking, they often exhibit poor motor coordination, resulting in short strides and high stride frequencies for speed maintenance.
Modified constraint-induced movement therapy has been employed to enhance lower-extremity function, but its effectiveness on key ambulation aspects like gait speed and balance remains unclear.
The reliance on the unaffected limb further impacts locomotive behavior, leading to stiff knee gait and reduced functional mobility.
This study aims to explore the therapy's effects on locomotion in hemiplegic children.
Studietype
Intervensjonell
Registrering (Antatt)
30
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Mohamed Ali Taha
- Telefonnummer: 01022599920
- E-post: dr.mo7amed.ali224@gmail.com
Studiesteder
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Cairo, Egypt
- Rekruttering
- outpatient clinic faculty of physical therapy, Cairo University
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Ta kontakt med:
- Mohamed Ali Taha
- Telefonnummer: 01022599920
- E-post: dr.mo7amed.ali224@gmail.com
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- The age of the selected children will range from 6 to 8 years old.
- Degree of spasticity will range from 1+ to 2 according to the modified Ashworth scale.
- The level of motor function of the children will be levels I-II according to the Gross Motor Function Classification System.
- Participants will present a score between 41 to 56 points on the pediatric balance scale.
- They will be able to follow instructions and understand commands.
Exclusion Criteria:
- Bone and tendon lengthening surgeries within the last 6 months.
- Lung and heart diseases and disorders.
- Vision or hearing problems.
- Children with fixed deformities in the lower extremity.
- Children with epilepsy.
- Recent intramuscular Botulinum toxin injection.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Modified constraint induced movement therapy
Fifteen children will receive a conventional physical therapy program for 1 hour and modified constraint-induced movement therapy for 30 minutes 3 times per week for 4 weeks.
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Three tasks will be designed to be performed for 10 min each while using the knee scooter as a method of constraint-induced movement therapy The 3 tasks will be as follows:
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Aktiv komparator: Conventional physical therapy
Fifteen children will receive conventional physical therapy program only for 1 hour 3 times per week for 4 weeks.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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assessment of spatial gait parameters
Tidsramme: At baseline and after Four weeks
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Kinovea is a free 2D motion analysis software that facilitates inexpensive, sensor-free video-based motion assessments suitable for clinical practice.
Its reliability has been established for measuring cervical range of motion (ROM) in both sagittal and frontal planes, dominant wrist joint ROM, shoulder ROM, and ankle joint ROM during walking.
Additionally, it effectively measures spatial gait parameters, including stride length, step length, and hip, knee, and ankle angles at initial contact and mid-swing stages of the gait cycle.
Required tools for its use include a walking area, digital camera, adhesive skin marks, and a tripod.
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At baseline and after Four weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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assessment of Temporal gait parameters
Tidsramme: At baseline and after four weeks
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Kinovea is a free 2D motion analysis software that utilizes inexpensive, sensor-free video-based techniques for clinical motion analysis.
Its reliability is essential for assessing important psychometric properties, especially in measuring various range of motion (ROM) for cervical, shoulder, and ankle joints, as well as capturing gait parameters like stance and swing phases.
Required tools for its use include a walking area, digital camera, adhesive skin marks, and a tripod.
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At baseline and after four weeks
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assessment of the functional mobility
Tidsramme: At baseline and after four weeks
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The Gross Motor Function Measure (GMFM-88) is a reliable and valid assessment tool for measuring gross motor function in children with cerebral palsy, specifically focusing on standing (segment D) and walking/running (segment E).
It is widely used in clinical and research settings to track changes over time or assess the impact of interventions.
Due to its lengthy administration time, it is best used for annual or biannual evaluations or research studies, and testers should be well-versed in its use prior to administration.
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At baseline and after four weeks
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. juni 2026
Primær fullføring (Antatt)
30. juli 2026
Studiet fullført (Antatt)
30. august 2026
Datoer for studieregistrering
Først innsendt
29. mai 2026
Først innsendt som oppfylte QC-kriteriene
2. juli 2026
Først lagt ut (Faktiske)
7. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
7. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- Mohamed Ali-PhD
Legemiddel- og utstyrsinformasjon, studiedokumenter
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