NCT05506527

Brief Summary

To examine if adding plyometric exercises to sensorimotor exercises would improve respiratory function in children and adolescents with cerebral palsy

Trial Health

43
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 Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

August 15, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 18, 2022

Completed
14 days until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

August 18, 2022

Status Verified

August 1, 2022

Enrollment Period

1 month

First QC Date

August 15, 2022

Last Update Submit

August 17, 2022

Conditions

Keywords

respiratory capacitycerebral palsyplyometric exercise

Outcome Measures

Primary Outcomes (1)

  • change of spasticity

    will be measured by modified Ashower Scale

    six weeks

Secondary Outcomes (1)

  • change of Respiratory capacity and vital capacity

    six weeks

Study Arms (2)

study group 1

EXPERIMENTAL

Study group A: will receive combined plyometric exercises and sensorimotor program

Other: Sensorimotor program and plyometric exercise

study group 2

EXPERIMENTAL

Study group B: will receive sensorimotor program alone

Other: Sensorimotor program and plyometric exercise

Interventions

Children in study group A will receive combined plyometric exercises (vertical paradigm) and sensorimotor program \- Children of the study group B will receive sensorimotor program alone.

study group 1study group 2

Eligibility Criteria

Age8 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age will be 8 - 14 years.
  • children will be assigned to the study are suffering from spastic hemiplegic cerebral palsy (less than grade 1+ om Modified Ashwar Scale)
  • Considering the physical problems, children will be chosen according to Growth Motor Function Classification System (GMFCS) with levels I-III
  • The ability to understand simple verbal instructions.

You may not qualify if:

  • Visual and hearing impairment; surgery within the last three months preventing them from taking part in sensorimotor physical therapy
  • Severe oromotor issues
  • Severe chest infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Giza, 12613, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Plyometric Exercise

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Eman Abdel-Halim

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Mohamed Abo-El-Ros, Ph.D

CONTACT

Marian Fayez, Ph.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
lottery method
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of physical therapy for pediatrics

Study Record Dates

First Submitted

August 15, 2022

First Posted

August 18, 2022

Study Start

September 1, 2022

Primary Completion

October 1, 2022

Study Completion

January 1, 2023

Last Updated

August 18, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations