NCT07347795

Brief Summary

The study aims to investigate the effect of blood flow restriction (BFR) training exercises on the hand grip strength of children with hemiparetic cerebral palsy. Hand grip strength is a vital component of motor function and is often severely compromised in children with hemiparetic CP, which can significantly impact their daily activities and quality of life. Blood flow restriction (BFR) training is a novel exercise technique where a cuff or band is used to partially occlude blood flow during low-intensity resistance exercises. This method has been shown to stimulate muscle growth and strength gains similar to those achieved through high-intensity strength training, without the need for high loads. Given the unique physiological challenges faced by children with hemiparetic CP, BFR training could provide an effective alternative to traditional strength training methods.

Trial Health

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Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
0mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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 Progress76%
Feb 2026Jun 2026

First Submitted

Initial submission to the registry

December 31, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 16, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

February 20, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

February 4, 2026

Status Verified

December 1, 2025

Enrollment Period

2 months

First QC Date

December 31, 2025

Last Update Submit

February 2, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Hand grip strength measured using a handheld dynamometer

    Hand grip strength of the affected hand will be assessed using a calibrated handheld dynamometer. The maximum voluntary grip force will be recorded in kilograms (kg). Three trials will be performed, and the highest value will be used for analysis.

    8 weeks

  • muscle thickness at the midpoint of the forearm flexor muscles

    8 weeks

Study Arms (2)

Control group

ACTIVE COMPARATOR

The control group performs traditional hand grip strengthening exercises, focusing on similar exercises but without blood flow restriction. Both groups participate in a similar frequency and duration of training, with a gradual increase in repetitions over the 8 weeks

Behavioral: control group

Study group

EXPERIMENTAL
Device: Blood Flow Restriction Training Exercises group

Interventions

The BFR group underwent BFR training for 8 weeks, with sessions held three times per week. A tourniquet-style cuff is placed on the upper arm to restrict blood flow during exercise. The exercises involved are low-intensity grip strengthening activities (e.g., squeezing a rubber ball, gripping a hand dynamometer) at 20% of their one-repetition maximum (1RM). The cuff pressure is set at 50-70% of the participants' limb occlusion pressure, as determined by an initial assessment.

Study group
control groupBEHAVIORAL

The control group performs traditional hand grip strengthening exercises, focusing on similar exercises but without blood flow restriction. Both groups participate in a similar frequency and duration of training, with a gradual increase in repetitions over the 8 weeks.

Control group

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age will range from 6-12 years
  • Diagnosed with hemiparetic cerebral palsy (right or left side).
  • According to Modified Ashwer scale, has grade 1 or 1+ grade
  • Children with the ability to understand and follow verbal commands and instructions used during training and tests

You may not qualify if:

  • Any contraindications to exercise, such as moderate or severe spasticity, orthopedic deformities, or other serious health conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo Universit

Giza, Egypt

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 31, 2025

First Posted

January 16, 2026

Study Start

February 20, 2026

Primary Completion

May 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

February 4, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations