Spastic DiplegiaNCT07617935
Effect of Vestibular Rehabilitation on Postural Sway and Energy Expenditure in Children With Spastic Diplegia
A study testing vestibular rehabilitation and conventional physical therapy in people with Spastic Diplegia, run by Cairo University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Spastic Diplegia
- What is being tested?
- vestibular rehabilitation and conventional physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2026to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
outpatient clinic, faculty of physical therapy, Cairo university
Cairo
About this study
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.
Read the 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.
- Conditions
- Spastic Diplegia
- Being tested
- vestibular rehabilitation, conventional physical therapy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vestibular rehabilitationOther
- Bouncing-jumping activities from standing.
- linear swinging activities: using swinging platform (standing walking) scooter activity (kneeling, standing), hanging lower limb activities and climbing swinging robe ladder.
- By pushing-pulling activities, displacement of the center of gravity is created.
- These are activities which enable active equilibrium on steep surfaces such as stairs.
- Walking on ramps.
- Walking unfamiliar surfaces such as balance disc, balance boards and balance beam
conventional physical therapyOther
- Balance exercise.
- Gait training (forward, backward and side way).
- Gait training with obstacles of different sizes.
- Gait training in stepper.
- Gait training on wooden ramp.
- Gait training on balance board.
- Training up and down steps different heights.
- Stretching exercise for upper limbs and lower limbs.
- Strengthening exercises for lower limbs muscles.
- Trunk control exercises like abdominal and back exercises.
| Study group | Role | What they receive |
|---|---|---|
| vestibular rehabilitation | Experimental | Fifteen children will receive conventional physical therapy program for 1 hour and vestibular rehabilitation for 30 minutes 3 times per week for 8 weeks Receives: Other: vestibular rehabilitation; Other: conventional physical therapy |
| conventional physical therapy | Active comparator | Fifteen children will receive conventional physical therapy program only for 1 hour 3 times per week for 8 weeks. Receives: Other: conventional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of postural sway
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.
Measured: at base line and after 8 weeks
Secondary outcomes (1)
assessment of Energy Expenditure
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
Measured: at base line and after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start1 Jun 2026
- Primary completion30 Aug 2026
- Study completion1 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spastic DiplegiaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nesma Abdelrahman, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07617935
- Sponsor's protocol ID
- Nesma-phd
- Status last verified
- Oct 2026
- First submitted
- 24 May 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vestibular Rehabilitation on Postural Sway and Energy Expenditure in Children With Spastic Diplegia
- ClinicalTrials.gov ID
- NCT07617935
- Acronym / sponsor ID
- Nesma-phd
- Conditions
- Spastic Diplegia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 30 Aug 2026 (actual)
- Study completion
- 1 Sep 2026 (actual)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vestibular rehabilitation | Experimental | Other: vestibular rehabilitation, Other: conventional physical therapyFifteen children will receive conventional physical therapy program for 1 hour and vestibular rehabilitation for 30 minutes 3 times per week for 8 weeks |
| conventional physical therapy | Active comparator | Other: conventional physical therapyFifteen children will receive conventional physical therapy program only for 1 hour 3 times per week for 8 weeks. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vestibular rehabilitation* Bouncing-jumping activities from standing. * linear swinging activities: using swinging platform (standing walking) scooter activity (kneeling, standing), hanging lower limb activities and climbing swinging robe ladder. * By pushing-pulling activities, displacement of the center of gravity is created. * These are activities which enable active equilibrium on steep surfaces such as stairs. * Walking on ramps. * Walking unfamiliar surfaces such as balance disc, balance boards and balance beam | Other | vestibular rehabilitation |
| conventional physical therapy* Balance exercise. * Gait training (forward, backward and side way). * Gait training with obstacles of different sizes. * Gait training in stepper. * Gait training on wooden ramp. * Gait training on balance board. * Training up and down steps different heights. * Stretching exercise for upper limbs and lower limbs. * Strengthening exercises for lower limbs muscles. * Trunk control exercises like abdominal and back exercises. | Other | conventional physical therapy, vestibular rehabilitation |
Primary outcome
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.
1 secondary outcome
assessment of Energy Expenditure
Time frame: at base line and after 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vestibular rehabilitation and conventional physical therapy in people with Spastic Diplegia, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of postural sway (time frame: at base line and after 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.