Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Effect of Myofeedback and Neuromuscular Electrical Stimulation on Hemiplegic Children After Brain Tumor Resection

17. mai 2026 oppdatert av: Amr Mohamed Sabry Lotfi Amer, Cairo University
This study was conducted to compare between the effect of neuromuscular electrical stimulation and myofeedback on upper limb function, muscle activity and brain derived neurotropic factor in blood for children with hemiplegia after brain tumor surgery.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Studies indicate that neuromuscular electrical stimulation is more effective than voluntary exercise in enhancing serum Brain-derived neurotrophic factor levels and improving muscle strength and mobility in children with conditions like cerebral palsy and spinal muscular atrophy. Myofeedback, particularly surface electromyography biofeedback, is beneficial for upper extremity function post-stroke, as it helps raise awareness and control of movements. Intensive electromyography biofeedback has shown significant recovery in hemiplegic children compared to traditional therapy. There is potential for a multimodal treatment approach that combines neuromuscular electrical stimulation and biofeedback to mitigate the effects of brain tumors on upper limb function and optimize Brain-derived neurotrophic factor levels.

Studietype

Intervensjonell

Registrering (Faktiske)

45

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Egypt
      • Alexandria, Egypt
        • Elmagd physical therapy centres, Teriaq oncology centre and Elite hospital.

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:

  • Age 6-14 years post brain tumor surgery children.
  • Children's hand use experience questionnaire between 25 and 50 on a scale of units.
  • Grade 2 muscle power of wrist, elbow and finger extensors.
  • Outpatient children.
  • Post-operative brain tumour, which is located in one of the two hemispheres.
  • After 6 weeks post-surgery.
  • The child can follow orders and instructions.

Exclusion Criteria:

  • Blindness.
  • Deaf child.
  • Skin diseases.

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
Aktiv komparator: selected physical therapy program
The control group will undergo a selected physical therapy (PT) program for one hour, three times weekly, over twelve weeks.
Annen: selected physical therapy program
The program includes push-up exercises, active strength training for wrist extensors using fine motor toys, stretching for wrist and elbow flexors and pronators, weight-bearing positions from side sitting, quadruped position with active limb elevation, rolling a small ball with the affected limb, and rhythmic muscle approximation for shoulder, elbow, and wrist.
Eksperimentell: selected physical therapy program and biofeedback
Patient will undergo a selected physical therapy program for one hour, three times a week, for twelve weeks, supplemented by a biofeedback program.
Annen: selected physical therapy program
The program includes push-up exercises, active strength training for wrist extensors using fine motor toys, stretching for wrist and elbow flexors and pronators, weight-bearing positions from side sitting, quadruped position with active limb elevation, rolling a small ball with the affected limb, and rhythmic muscle approximation for shoulder, elbow, and wrist.
Enhet: biofeedback
During sessions, the child sits with an arm resting on a table, with electrodes placed on the wrist extensors and forearm. The treatment involves gradually increasing the intensity of faradic current to induce muscle contraction. Each session lasts 30 minutes to one hour, with treatments up to three times daily, using a frequency of 50-100 Hz and a pulse duration of 0.1-1 ms, for a duration of 2 weeks to 3 months.
Eksperimentell: selected physical therapy program and neuromuscular electric stimulation
The child will participate in a physical therapy program for one hour, three times a week, over twelve weeks, supplemented by neuromuscular electric stimulation.
Annen: selected physical therapy program
The program includes push-up exercises, active strength training for wrist extensors using fine motor toys, stretching for wrist and elbow flexors and pronators, weight-bearing positions from side sitting, quadruped position with active limb elevation, rolling a small ball with the affected limb, and rhythmic muscle approximation for shoulder, elbow, and wrist.
Enhet: neuromuscular electric stimulation
The child will participate in a physical therapy program for one hour, three times a week, over twelve weeks, supplemented by neuromuscular electric stimulation. During sessions, the child sits with an arm resting on a table, with electrodes placed on the wrist extensors and forearm. The treatment involves gradually increasing the intensity of faradic current to induce muscle contraction. Each session lasts 30 minutes to one hour, with treatments up to three times daily, using a frequency of 50-100 Hz and a pulse duration of 0.1-1 ms, for a duration of 2 weeks to 3 months.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Assessment of muscle activity
Tidsramme: at baseline and after 12 weeks
All children will be assessed using surface electromyography for wrist extensor muscles while sitting, with their upper limbs resting on a desk and utilizing three electrodes. The ground electrode (black) is placed proximal to the others, the active electrode (yellow) is on the common extensor origin, and the connector (blue) is positioned at least 3 cm distally. After registering new patient data, the assessment begins via a one-channel surface electromyography setup, recording maximum and mean muscle activity during wrist extension upon pressing the play button.
at baseline and after 12 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Assessment of upper limb function
Tidsramme: at baseline and after 12 weeks
Using the short form of the Bruininks-Oseretsky Test, which includes fourteen selected test items, subtests 1, 2, 3, 4, and 7 are administered. The child is positioned sitting at a table. The time taken for each task is noted as part of the proficiency evaluation. Performance is recorded, and raw scores are converted to point scores using a conversion table. The better result from two trials for each item is taken, and the total points from the fourteen short items are recorded in the designated area.
at baseline and after 12 weeks
assessment of level of neurotrophic factor
Tidsramme: at baseline and after 12 weeks
Fasting blood samples were taken in potassium-methylene diamine tetra acetic acid tubes, centrifuged for 15 minutes at 3000 rpm, and the plasma was stored at -80°C before being sent to Myriad RBM for a 190-analyte multiplex immunoassay. Additionally, the Brain-derived neurotrophic factor enzyme-linked immunosorbent assay reliably measures whole blood Brain-derived neurotrophic factor with high reproducibility.
at baseline and after 12 weeks
assessment of dynamic spasticity of wrist and elbow flexors muscles
Tidsramme: at baseline and after 12 weeks
Dynamic spasticity of wrist and elbow flexors muscles will be analyzed at the study's start and end. Measurements will include resistance 1 (fast velocity movement through full range of motion to identify the point of catch), resistance 2 (passive range of motion), and the difference resistance 2-resistance 1 (dynamic spasticity component). The Modified Ashworth Scale serves as a clinical tool for assessing spasticity, employing quantitative measurements at two speeds: slow (resistance 2) and fast (resistance 1).
at baseline and after 12 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Cairo University

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. juli 2024

Primær fullføring (Faktiske)

1. juni 2025

Studiet fullført (Faktiske)

1. september 2025

Datoer for studieregistrering

Først innsendt

17. mai 2026

Først innsendt som oppfylte QC-kriteriene

17. mai 2026

Først lagt ut (Faktiske)

26. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

26. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • Amr-phd

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere