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

10. juni 2026 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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
Andet: 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.
Eksperimentel: 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
Andet: 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.
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Assessment of muscle architecture
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Assessment of muscle strength
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Cairo University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

5. oktober 2025

Primær færdiggørelse (Faktiske)

1. december 2025

Studieafslutning (Faktiske)

20. december 2025

Datoer for studieregistrering

Først indsendt

10. juni 2026

Først indsendt, der opfyldte QC-kriterier

10. juni 2026

Først opslået (Faktiske)

15. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Ibrahim-Msc

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Kliniske forsøg med Hemiplegi

Kliniske forsøg med the selected physical therapy program

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Sponsorer og samarbejdspartnere

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Betingelser

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Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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