NCT06086678

Brief Summary

Cerebral palsy (CP) is the most common motor disability in childhood. Respiratory muscle weakness and a low upper to lower chest diameter ratio are common respiratory dysfunction manifestations in those children which negatively affect their quality of life..

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
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

October 15, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 17, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2024

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2024

Completed
Last Updated

October 17, 2023

Status Verified

October 1, 2023

Enrollment Period

3 months

First QC Date

October 11, 2023

Last Update Submit

October 16, 2023

Conditions

Keywords

Aerobic exercise; Cerebral palsy; Children; Hemiplegia; Pulmonary function

Outcome Measures

Primary Outcomes (3)

  • Forced vital capacity (FVC)

    Pulmonary function test

    12 consecutive weeks

  • Pulmonary function tests Forced expiratory volume in the first second (FEV1)

    Pulmonary function test

    12 consecutive weeks

  • FEV1/FVC ratio

    Pulmonary function test

    12 consecutive weeks

Secondary Outcomes (1)

  • Six-minute walk test (6-MWT)

    12 consecutive weeks

Study Arms (3)

Conventional physical therapy group

EXPERIMENTAL

Strengthening exercises, stretching exercises for the weak and tightened muscles respectively, facilitation of equilibrium and protective reactions and breathing exercises in form of Deep breathing, Diaphragmatic breathing and Pursed lip breathing exercises

Other: Conventional physical therapy

Hydrotherapy and conventional physical therapy group

EXPERIMENTAL

Strengthening exercises, stretching exercises for the weak and tightened muscles respectively, facilitation of equilibrium and protective reactions and breathing exercises in form of Deep breathing, Diaphragmatic breathing and Pursed lip breathing exercises in addition to hydrotherapy

Other: Conventional physical therapyOther: Hydrotherapy

Aerobic exercise and conventional physical therapy group

EXPERIMENTAL

Strengthening exercises, stretching exercises for the weak and tightened muscles respectively, facilitation of equilibrium and protective reactions and breathing exercises in form of Deep breathing, Diaphragmatic breathing and Pursed lip breathing exercises in addition to aerobic exercise

Other: Conventional physical therapyOther: Aerobic exercise

Interventions

1. Deep breathing exercise. 2. Diaphragmatic breathing exercise. 3. Pursed lip breathing exercise.

Also known as: Physical therapy
Aerobic exercise and conventional physical therapy groupConventional physical therapy groupHydrotherapy and conventional physical therapy group

1. Water walking exercise. 2. Forward lunges exercise. 3. Single leg balance exercise. 4. Side stepping exercise. 5. Push ups exercise. 6. Standing knee lifts exercise.

Also known as: Physical therapy
Hydrotherapy and conventional physical therapy group

Aerobic exercise in form of treadmill training when each child was standing on the treadmill, should be ensure that this standing in an upright position, and according to each child, the therapist corrected the height of the handrails. Ask the child to keep looking forwards along the walking on the treadmill aiming to encourage the setting of walking free. The treadmill training would be completed for each child when the child completes three stages in 1-min training cycles. First stage: the child grasped on to the rails with both hands in first 15 s of every 1-min. Second stage: the child grasped on to the railings with one hand in the second 15 s. And final stage: the child didn't grasp on to the railings in last 30 s. Every child performed this procedure twenty times

Also known as: Physical therapy
Aerobic exercise and conventional physical therapy group

Eligibility Criteria

Age8 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Ages ranged from 8 to 16 years.
  • Belonged to levels I to II of the Gross Motor Function Classification System (GMFCS).
  • Spasticity ranged from grade 1 to grade 1+ according to Modified Ashwarth Scale. - Able to walk, no impairment of sensation or other neurological or psychological problems.
  • Clinically and medically stable and able to understand and follow the instructions

You may not qualify if:

  • i) Visual and/or auditory defects. ii) Significant shortening and/or deformity of lower extremities. iii) Other neurological problems that affect balance or mentality (e.g. epilepsy) iv) Advanced radiographic alterations comprise (bone destruction, bony ankylosis, knee joint sublaxation as well as epiphysial fracture).
  • v) Lower extremity skeletal abnormalities (whether congenital or acquired). vi) Cardiopulmonary dysfunction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ragaee Saeed Mahmoud

Giza, Faisal, Egypt

RECRUITING

MeSH Terms

Conditions

Cerebral PalsyHemiplegia

Interventions

Physical Therapy ModalitiesHydrotherapyExercise

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitationMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
single
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: random
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

October 11, 2023

First Posted

October 17, 2023

Study Start

October 15, 2023

Primary Completion

January 15, 2024

Study Completion

January 20, 2024

Last Updated

October 17, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations