NCT07748052

Brief Summary

load resistance exercises are performed while partially restricting venous blood flow to the exercising limb using a pneumatic cuff. In children with hemiplegic cerebral palsy, this intervention has been proposed to enhance muscle strength and hypertrophy while minimizing mechanical stress on joints and soft tissues. Previous studies suggest that BFR training may improve muscle thickness, muscle strength, functional mobility, gait performance, and overall physical function compared with conventional low-intensity strength training alone. However, careful monitoring of cuff pressure, exercise intensity, and safety considerations is essential when applying this technique in pediatric populations.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
11mo left

Started Aug 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Aug 2026Jul 2027

First Submitted

Initial submission to the registry

July 30, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 5, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

August 6, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2027

Last Updated

August 5, 2026

Status Verified

August 1, 2026

Enrollment Period

6 months

First QC Date

July 30, 2026

Last Update Submit

August 3, 2026

Conditions

Keywords

cerebral palsyprogressive resistive exerciselow load resistive trainingblood flow restriction

Outcome Measures

Primary Outcomes (2)

  • ultrasonography for measuring muscle thickness

    6 weeks

  • quality of upper-extremity skills test for measuring upper limb function

    6 weeks

Study Arms (2)

strength training combined with blood flow restriction and designed physical therapy program

EXPERIMENTAL
Other: strength training combined with blood flow restriction and designed physical therapy program

designed physical therapy program

EXPERIMENTAL
Other: a specially designed physical therapy program

Interventions

A specially designed physical therapy program in addition to progressive resistive exercises for 60 min (30 min designed P.T program and other 30 min for progressive resistive exercise with blood flow restriction ), 3 sessions/ week for 6 successive weeks. strengthening exercise for shoulder flexors, abductors and external rotators, elbow flexors and extensors will be applied with low load while blood flow restriction is applied proximal to the limb

strength training combined with blood flow restriction and designed physical therapy program

conventional physical therapy program including reinforcement of the normal motor development, reflex inhibiting patterns, postural reaction, stretching, strengthening exercises, and gait training was applied to children in the control group

designed physical therapy program

Eligibility Criteria

Age4 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • A diagnosis of spastic hemiplegic CP
  • Degree of spasticity ranges from 1+ and 2, according to modified Ashworth scale (MAS)
  • The age of the selected children will range from 4 to 6 years old.
  • Children are levels II and III according to GMFCS

You may not qualify if:

  • Children with visual or auditory problems. 2. Children with severe intellectual disability (IQ less than 65 according to Stanford Binet intelligence scale).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor at faculty of physical therapy, cairo university

Study Record Dates

First Submitted

July 30, 2026

First Posted

August 5, 2026

Study Start

August 6, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

July 11, 2027

Last Updated

August 5, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share