NCT07072533

Brief Summary

To evaluate the effect of blood flow restriction combined with aerobic training on chest muscle strength in individual with diaplegic cerebral palsy

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

June 28, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 18, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

July 18, 2025

Status Verified

July 1, 2025

Enrollment Period

4 months

First QC Date

June 28, 2025

Last Update Submit

July 9, 2025

Conditions

Cerebral Palsy Spastic Diplegia

Outcome Measures

Primary Outcomes (1)

  • Chest muscle strength

    chest muscle strength will be measured by handheld dynamometry measured in Newton

    3 months

Secondary Outcomes (4)

  • pulmonary function tests

    3 months

  • sub-maximal aerobic capacity

    3 months

  • quality f life

    3 months

  • oxygen saturation and heart rate response

    3 months

Study Arms (2)

blood flow restriction combined with aerobic training

EXPERIMENTAL

individual will do blood flow restriction aerobic training

Other: blood flow restriction training

aerobic training only

ACTIVE COMPARATOR

individual will do aerobic training

Other: blood flow restriction training

Interventions

blood flow restriction trainingOTHER

individual will do aerobic training .

Also known as: aerobic training
aerobic training onlyblood flow restriction combined with aerobic training

Eligibility Criteria

Age12 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • diaplegic cerebral palsy. GMFCS level I-III. medically stable.

You may not qualify if:

  • severe cognitive impairment. cardio respiratory contraindication. previous thoracic surgery or musculoskeletal deformities affecting chest.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Central Study Contacts

Salah Eid Ahmed Ali, Assis Lect

CONTACT

01158125773Salah.Eid@sue.edu.eeg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Group A which is the experimental group treated with blood flow restriction plus aerobic training and group B which is the control group treated with aerobic trainin only.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

June 28, 2025

First Posted

July 18, 2025

Study Start

August 1, 2025

Primary Completion

December 1, 2025

Study Completion

February 1, 2026

Last Updated

July 18, 2025

Record last verified: 2025-07