Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Effect of Lower Extremity Modified Constraint-induced Movement Therapy on Locomotion in Children With Hemiplegia

2 juli 2026 uppdaterad 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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

30

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

      • Cairo, Egypten
        • Rekrytering
        • outpatient clinic faculty of physical therapy, Cairo University
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn

Tar emot friska volontärer

Nej

Beskrivning

Inclusion Criteria:

  1. The age of the selected children will range from 6 to 8 years old.
  2. Degree of spasticity will range from 1+ to 2 according to the modified Ashworth scale.
  3. The level of motor function of the children will be levels I-II according to the Gross Motor Function Classification System.
  4. Participants will present a score between 41 to 56 points on the pediatric balance scale.
  5. They will be able to follow instructions and understand commands.

Exclusion Criteria:

  1. Bone and tendon lengthening surgeries within the last 6 months.
  2. Lung and heart diseases and disorders.
  3. Vision or hearing problems.
  4. Children with fixed deformities in the lower extremity.
  5. Children with epilepsy.
  6. Recent intramuscular Botulinum toxin injection.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.

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:

  1. Walking with knee scooter forward on 8 meter walkway
  2. Walking with knee scooter backward on 8 meter walkway
  3. Standing with the knee scooter on balance board
  1. Repetitive motor training following shaping task

    • Step on stool.
    • Squat to stand.
    • Pressing the pedal stepper.
    • Walking on treadmill.
    • Bicycle.
    • Air walker.
  2. Behavioral strategies:

    • Walking with picking toys from ground
    • Passing obstacles
    • Walking with a ball, moving it by the lower extremity
Aktiv komparator: Conventional physical therapy
Fifteen children will receive conventional physical therapy program only for 1 hour 3 times per week for 4 weeks.
  1. Repetitive motor training following shaping task

    • Step on stool.
    • Squat to stand.
    • Pressing the pedal stepper.
    • Walking on treadmill.
    • Bicycle.
    • Air walker.
  2. Behavioral strategies:

    • Walking with picking toys from ground
    • Passing obstacles
    • Walking with a ball, moving it by the lower extremity

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
assessment of spatial gait parameters
Tidsram: At baseline and after Four weeks
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.
At baseline and after Four weeks

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
assessment of Temporal gait parameters
Tidsram: At baseline and after four weeks
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.
At baseline and after four weeks
assessment of the functional mobility
Tidsram: At baseline and after four weeks
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.
At baseline and after four weeks

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 juni 2026

Primärt slutförande (Beräknad)

30 juli 2026

Avslutad studie (Beräknad)

30 augusti 2026

Studieregistreringsdatum

Först inskickad

29 maj 2026

Först inskickad som uppfyllde QC-kriterierna

2 juli 2026

Första postat (Faktisk)

7 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

7 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

2 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • Mohamed Ali-PhD

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera