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Effect of Blood Flow Restriction Training on Quadriceps Muscle Architecture and Functional Abilities in Children With Hemiplegia

10 giugno 2026 aggiornato da: Eman Kamal Abdelmoteleb, Cairo University

This study was done to investigate the effect of blood flow restriction in the lower limbs on:

Strength of the quadriceps muscle, quadriceps muscle architecture (muscle thickness and pennation angle between muscle fibres), selective motor control of the lower limb in the affected limb, and gait parameters.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Current clinical practice for managing children with cerebral palsy employs various treatments rather than a single approach. Blood flow restriction training, using pneumatic tourniquets to restrict blood flow to limbs, results in hypoxia and increased intramuscular pressure during contractions. Although research on blood flow restriction has expanded, many practitioners lack clarity on its application and safety. Evidence indicates that Blood flow restriction resistance exercise enhances muscle strength and hypertrophy more effectively than low-load resistance exercise alone. This study suggests a multimodal treatment combining Blood flow restriction and strength training could expedite rehabilitation, particularly for children with hemiplegia.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

30

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Egitto
      • Al Mansurah, Egitto
        • outpatient clinics of General Hospitals in Dakahlia governorate.

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Hemiplegic cerebral palsied children.
  • The children age will be ranges from 3-8 years chronologically.
  • The children will have degree of spasticity ranged from 1 to 2 on Modified Ashworth Scale
  • The children will have Level I according to the Gross Motor Function Classification System.
  • All children will be able to follow instructions.

Exclusion Criteria:

children were excluded from the study if they have any problems of the following:

  • Cognitive dysfunction.
  • Recent nonunion fracture.
  • Fixed contractures and deformities.
  • Previous surgery and Impaired circulation of that lower limb.
  • Received Botulinum toxin A injections in the last six months.
  • Children suffers from Peripheral Arterial and venous Diseases in the hemiplegic limb.
  • Children suffering from uncontrolled convulsions.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: selected physical therapy program
Children in the control group will receive the selected physical therapy (PT) program one hour three times weekly for eight successive weeks
Altro: the selected physical therapy program
The physical therapy program includes passive stretching exercises for the lower limb to enhance range of motion (ROM) in children with cerebral palsy (CP), transition training from sitting to standing to improve postural control, and core stability exercises to boost trunk endurance and gait. Reactive balance training aims to improve children's postural response organization, while various walking training methods, including treadmill and obstacle walking, focus on enhancing gait speed, balance, and postural stability. Overall, the program is designed to address specific impairments and activity limitations in children with hemiplegic CP.
Sperimentale: selected physical therapy program and Blood Flow Restriction
This group will receive the selected physical therapy program as group (A) in addition to blood flow restriction on the upper thigh. Training Frequency will be one hour for 2-3 times a week for 8 weeks
Altro: the selected physical therapy program
The physical therapy program includes passive stretching exercises for the lower limb to enhance range of motion (ROM) in children with cerebral palsy (CP), transition training from sitting to standing to improve postural control, and core stability exercises to boost trunk endurance and gait. Reactive balance training aims to improve children's postural response organization, while various walking training methods, including treadmill and obstacle walking, focus on enhancing gait speed, balance, and postural stability. Overall, the program is designed to address specific impairments and activity limitations in children with hemiplegic CP.
Altro: Blood Flow Restriction training
This group will undergo a physical therapy program incorporating Blood Flow Restriction therapy on the upper thigh. The training will consist of one hour sessions, 2-3 times a week for 8 weeks. The load applied will be 20-40% of One-repetition maximum (1RM), with 5-10 minutes of restriction time per exercise set. Each session will include 4 sets, totaling 75 repetitions (30 × 15 × 15 × 15), along with reperfusion between sets. Pressure application will be 40-80% of arterial occlusion pressure (AOP), with rest periods of 30-60 seconds between sets. The restriction form will be continuous, with an execution speed of 1-2 seconds for each exercise, continuing until the planned repetitions are completed.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Assessment of muscle architecture
Lasso di tempo: at baseline and after 8 weeks
One method to evaluate muscle function and morphology is through skeletal muscle architecture analysis, which examines the geometric arrangement of muscle fibers using non-invasive ultrasound techniques. Key parameters include muscle thickness, which correlates with strength, and pennation angle, which affects force transmission to tendons. Measurements are conducted with participants supine, allowing stabilization, and involve high-quality ultrasound imaging (B-mode) for consistent results. An experienced researcher measures muscle thickness and pennation angle using standardized protocols and software for analysis, ensuring accuracy across assessments.
at baseline and after 8 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Assessment of muscle strength
Lasso di tempo: at baseline and after 8 weeks
The isometric strength of knee extensor muscles will be measured using a handheld dynamometer, with a standardized position. A 'make' test will require participants to exert maximum effort against a constant resistance for 3 to 5 seconds. Children will be positioned with the dynamometer on the anterior tibia, while seated with knees and hips flexed at 90 degrees. Each child will have two practice trials before performing three trials, receiving strong encouragement to maximize force output, which will be recorded. If a participant cannot effectively isolate the muscle group or generate sufficient force, a zero score will be noted.
at baseline and after 8 weeks
Assessment of selective motor control
Lasso di tempo: at baseline and after 8 weeks
The Scale evaluates five reciprocal lower extremity movements: hip flexion-extension, knee flexion-extension, ankle dorsiflexion-plantar flexion, subtalar inversion-eversion, and toe flexion/extension. The hip test is performed in a side-lying position, while the others are conducted in a seated position. Each movement is passively executed by the tester using a three-second verbal cadence. Each limb is assessed separately, focusing on selective joint movement and avoiding extraneous motions. Movements are scored on a scale of 0-2: 2 (Normal) for complete movements within the cadence, 1 (Impaired) for partial isolated movements or deviations, and 0 (Unable) for lack of movement initiation. The total score per limb can reach a maximum of 10.
at baseline and after 8 weeks
Assessment of gait
Lasso di tempo: at baseline and after 8 weeks
The observational gait scale will be used to analyze typical walk viewed on split-screen video in slow motion. The children will be instructed to walk, and videos will be taken from the side. Children will be videotaped, six sections will be tested to evaluate knee and ankle kinematics (Knee position in mid stance, Initial foot contact, Foot contact at mid stance, Base of support, Gait assistive devices, degree of change) with a total score of 22 on each limb.
at baseline and after 8 weeks

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Cairo University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

5 ottobre 2025

Completamento primario (Effettivo)

1 dicembre 2025

Completamento dello studio (Effettivo)

20 dicembre 2025

Date di iscrizione allo studio

Primo inviato

10 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

10 giugno 2026

Primo Inserito (Effettivo)

15 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

15 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • Ibrahim-Msc

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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