NCT07502274

Brief Summary

Purpose:The purpose of the study was to evaluate the effectiveness of respiratory muscle strengthening on trunk control in children with spastic diplegic cerebral palsy . Subjects and Methods: Thirty children with spastic diplegic cerebral palsy aged from 8to 10 years selected with impaired trunk control and respiratory problems .They have spasticity degree of 1 to 2 according to modified Ashwarth scale. classified into 2 equal groups: control and study. Evaluation w by trunk control measurement scale and spirometer test pre and post treatment.Both groups will receive conventional program designed for diplegic cerebral palsy children in addition to incentive spirometer for study group and breathing exercises for control group for 1hour, three times per week for 1 month .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

March 15, 2026

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 30, 2026

Completed
Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

10 days

First QC Date

March 25, 2026

Last Update Submit

March 25, 2026

Conditions

Keywords

diplegia

Outcome Measures

Primary Outcomes (1)

  • respiratory function

    maximum inspiratory and expiratory volume

    pre and after 1 month

Secondary Outcomes (1)

  • trunk control

    pre and post 1 month

Study Arms (2)

control group

ACTIVE COMPARATOR

regular respiratory exercises

Other: Exercise

study

EXPERIMENTAL

respiratory training by spirometer

Other: Exercise

Interventions

respiratory training by spirometer in addition to trunk control exercises

control groupstudy

Eligibility Criteria

Age8 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Inclusive criteria: 1. Children age ranged from 8 to 10 years old. 2. They were diagnosed as spastic diplegic cerebral palsy. 3. They had spasticity grade from1 to 2 according to modified Ashwarthe scale(appendix-II)(Balzer et al ,.2018) . 4. They had trunk control problems according to trunk control measurement scale (appendix-III)(Heyrman et al., 2011) . 5. They are able to follow orders and instructions. 6. They have respiratory function problems. Exclusive criteria: Children excluded if they had any of the following issues: 1. Having fixed deformities at lower limbs which affects sitting abilities. 2. Recent spine or lower limb surgeries or lower limbs Botox injection in the last six months before the study . 3. Moderate to sever scoliosis or spinal deformities. 4. Chest infection.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Cairo university

Giza, Egypt

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

March 25, 2026

First Posted

March 30, 2026

Study Start

March 15, 2026

Primary Completion

March 25, 2026

Study Completion

March 25, 2026

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations