- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07617935
Effect of Vestibular Rehabilitation on Postural Sway and Energy Expenditure in Children With Spastic Diplegia
May 24, 2026 updated by: Nesma Abdelrahman, Cairo University
this study will be conducted To determine the effect of vestibular rehabilitation training on postural sway and energy expenditure in children with spastic cerebral palsy and To determine any relation between postural sway and energy expenditure in children with spastic cerebral palsy.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Cerebral palsy leads to postural asymmetries and balance impairments, primarily due to central vestibular dysfunction.
Children aged 7-12 with gross motor function classification system levels I-III exhibit poor visual and vestibular interactions, impacting their ability to resolve sensory conflicts and manage reflexes.
Excessive lateral trunk lean in cerebral palsy, prevalent in 72% of affected children, increases locomotion costs.
Energy expenditure during walking rises with declining motor function, particularly in spastic cerebral palsy where vestibular dysfunction affects nearly 48% of cases.
The relationship between balance control efforts and metabolic energy expenditure is complex, especially during dynamic activities like walking.
This study will assess the impact of vestibular rehabilitation on postural sway and energy expenditure in children with spastic cerebral palsy, aiming to elucidate their interrelationship.
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nesma Abdelrhman Farag, assistant lecturer
- Phone Number: 01016612043
- Email: nesmafarag2018@gmail.com
Study Locations
-
-
-
Cairo, Egypt
- outpatient clinic, faculty of physical therapy, Cairo university
-
Contact:
- Nesma Abdelrhman Farag, assistant lecturer
- Phone Number: 01016612043
- Email: nesmafarag2018@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- The age of the selected children will be ranged from 8 to 12 years old.
- Degree of spasticity is ranging from 1+to 2 according to modified Ashworth scale
- The level of motor function of the children will be levels I-II according to Gross Motor Function Classification System
- They are able to follow instructions and understand commands.
Exclusion Criteria:
- Bone and tendon lengthening surgeries within last 6 months.
- Lung and heart diseases and disorders.
- Vision or hearing problems
- Children with fixed deformities.
- Children with epilepsy.
- Recent intramuscular Botulinum toxin injection or orthopedic surgery within last 6 months.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: vestibular rehabilitation
Fifteen children will receive conventional physical therapy program for 1 hour and vestibular rehabilitation for 30 minutes 3 times per week for 8 weeks
|
|
|
Active Comparator: conventional physical therapy
Fifteen children will receive conventional physical therapy program only for 1 hour 3 times per week for 8 weeks.
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
assessment of postural sway
Time Frame: at base line and after 8 weeks
|
The process for measuring frontal plane lateral trunk tilt angle during gait involves several steps as per the studies.
First, three circular adhesive dots are placed on the sternal notch and the anterior superior iliac spine.
A video camera is set up to capture the child's full body while walking.
The recorded video is analyzed using Kinovea, dividing the gait cycle into 11 frames at 10% intervals.
The angle of trunk deviation from vertical is calculated in these frames by connecting the anterior superior iliac spine markers and the sternal notch to determine the longitudinal axes of the trunk, with the angle measured against a vertical line.
|
at base line and after 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
assessment of Energy Expenditure
Time Frame: at base line and after 8 weeks
|
Heart rate expressed per distance walked provides information on energy economy as dose oxygen uptake expressed per distance walked because resting heart rate is known to increase with decreased body size and level of fitness, the resting heart rate is subtracted from the walking heart rate, and this value is divided by the walking speed.
The following calculation of an energy expenditure index (energy expenditure index; beats/minute) energy expenditure index heart rate = (exercise heart rate-resting heart rate)/speed measured in m·min
|
at base line and after 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
August 30, 2026
Study Completion (Estimated)
September 1, 2026
Study Registration Dates
First Submitted
May 24, 2026
First Submitted That Met QC Criteria
May 24, 2026
First Posted (Actual)
June 1, 2026
Study Record Updates
Last Update Posted (Actual)
June 1, 2026
Last Update Submitted That Met QC Criteria
May 24, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Nesma-phd
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Spastic Diplegia
-
Cairo UniversityUnknownSpastic Diplegia Cerebral PalsyEgypt
-
National Institute of Neurological Disorders and...Completed
-
Lahore University of Biological and Applied SciencesNot yet recruitingSpastic Diplegia Cerebral PalsyPakistan
-
Amira saad mohamedActive, not recruiting
-
Suleyman Demirel UniversityCompletedCerebral Palsy | Hemiplegic Cerebral Palsy | Spastic Diplegia Cerebral PalsyTurkey (Türkiye)
-
Columbia UniversityRecruitingCerebral Palsy | Spastic Diplegia | Spastic Hemiplegia | Spastic QuadriplegiaUnited States
-
Lamis Neyazy ElrakhawyCompletedSpastic Diplegia Cerebral PalsyEgypt
-
Wroclaw University of Health and Sport SciencesNot yet recruitingSpastic Diplegia Cerebral Palsy | Spastic HemiplegiaPoland
-
Cairo UniversityRecruitingCerebral Palsy (CP) | Spastic DiplegiaEgypt
-
Riphah International UniversityCompletedCerebral Palsy Spastic DiplegiaPakistan
Clinical Trials on vestibular rehabilitation
-
Abant Izzet Baysal UniversityRecruitingMeniere DiseaseTurkey (Türkiye)
-
Oregon Health and Science UniversityPortland VA Medical CenterCompletedBrain InjuryUnited States
-
National Cheng Kung UniversityRecruiting
-
Maria Jesus Casuso-HolgadoWithdrawnQuality of Life | Multiple Sclerosis | Fatigue | Dizziness | Vestibular Disease | Usability | Balance Disorders | CybersicknessSpain
-
Ege UniversityTHE SCİENTİFİC AND TECHNOLOGİCAL RESEARCH COUNCİL OF TURKEY (TUBITAK)CompletedVestibular MigraineTurkey (Türkiye)
-
Ankara City Hospital BilkentCompletedVestibular Diseases | Vestibular Disorder | Vestibular VertigoTurkey
-
Boston Children's HospitalCompletedVestibular DiseasesUnited States
-
University of British ColumbiaRecruitingLabyrinthitis | Benign Paroxysmal Positional Vertigo | Vestibular Neuronitis | Meniere Disease | Vestibular Neuritis | Herpes Zoster Oticus | Peripheral Vestibular DisorderCanada
-
Ege UniversityCompletedVestibular Disorder | Peripheral Vestibular DisorderTurkey