Balance BoardNCT06964386
Effect of Specially Designed Balance Board on Standing Balance in Children With Diplegic Cererbral Palsy
A study testing The traditional physical therapy rehabilitation exercises, balance training on traditional balance board and program on special form of balance board in people with Balance Board and Standing Balance, run by Cairo University at 1 site in Egypt.
Trial summary
This was done to: 1. To determine the effect of a specially designed balance board on balance ability. 2. To determine the effect of the traditional balance training program on balance ability. 3. Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Balance Board, Standing Balance, Diplegic Cerebral Palsy
- What is being tested?
- The traditional physical therapy rehabilitation exercises, balance training on traditional balance board and program on special form of balance board
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 1 Feb 2024
- 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 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Their ages ranged from 4 to 8 years old.
- The degree of spasticity ranged from grade 1 or 1+ according to Modified Ashworth Scale
- They were at level I or II on gross motor function classification scale.
- They were able to follow verbal command or instructions.
Who cannot join
- Children were excluded if they had one of the following :
- Fixed deformities of lower limbs.
- Visual or auditory problems.
- History of surgical interference in lower limbs less than six months.
- Botulinum toxin injections to the lower limb during the previous 4 months.
- Mental retardation.
- Fixed deformity
Trial locations and contacts
1 site in 1 country.
Egypt1 site
out-patient clinic, faculty of physical therapy, Cairo university
Cairo
About this study
This was done to:
- To determine the effect of a specially designed balance board on balance ability.
- To determine the effect of the traditional balance training program on balance ability.
- To compare between the effect of a specially designed balance board and the traditional balance training program on balance ability.
Read the detailed description
Children with cerebral palsy (CP) often experience abnormal posture, loss of motor control, and poor trunk control, leading to limitations in daily activities. Improving balance abilities is crucial for maintaining equilibrium in sensory environments. Vestibular stimulation can help develop feed-forward mechanisms and new functional skills. This study aims to improve balance abilities in children with diplegic CP, explore the impact of balance boards on vestibular and hand function, and assist mothers in their child's improvement.
- Conditions
- Balance Board, Standing Balance, Diplegic Cerebral Palsy
- Being tested
- The traditional physical therapy rehabilitation exercises, balance training on traditional balance board, program on special form of balance board
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The traditional physical therapy rehabilitation exercisesOther
It included 30 minutes of exercises as:
- Incorporated stretching (adductors, calf, and hamstring muscles)
- Range of motion for hip, knee, and ankle joints.
- Core stability exercises.
- climbing stairs and weight-bearing activities for strengthening, such as sit-to-stand and attaining standing position by half kneeling
balance training on traditional balance boardOther
Balance training included: - Side stepping - Stepping backward - Changing the center of gravity in one-foot balance.
program on special form of balance boardOther
Standing holding on the sticks of balance board (first by two sticks, then graduated by one stick).
2- Changing the grasp of hand on sticks (reciprocal catching the sticks by right and left hand).
3- Stride standing on balance board. 4- Make exercises advanced by remove sticks and throwing the ball. 5- All previous exercises do with eye closed and eye opened
| Study group | Role | What they receive |
|---|---|---|
| the traditional program | Experimental | twenty Children in group A received designed physical therapy program in addition to traditional balance training Receives: Other: The traditional physical therapy rehabilitation exercises; Other: balance training on traditional balance board |
| balance training exercises | Active comparator | twenty Children in group B received the same designed physical therapy program in addition to balance training exercises on special form of balance board Receives: Other: The traditional physical therapy rehabilitation exercises; Other: program on special form of balance board |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of degree of spasticity
Assessment of tone involves the clinician passively moving the patient's joints slowly and quickly and rating the degree of resistance felt to rapid stretch, typically as increased or decreased relative to a presumed normal (Hugos and Cameron, 2019). Only spastic diplegic children with grade 1 and 1+ will be included in the study
Measured: at baseline and after 3 months
Secondary outcomes (3)
Assessment of change of gross motor function level
This study will involve children with diplegic cerebral palsy at level II, who can walk, climb stairs, and perform gross motor skills like running and jumping. They will be allowed to engage in functional activities without interruption from caregivers or therapists. The study will record their activities using gross motor function classification system, taking about 10 minutes. Children with level II may struggle with long distances, balancing, and uneven terrain, and may require assistance with physical assistance or wheeled mobility.
Measured: at baseline and after 3 months
assessment of change of balance
it is an electronic balance board with HUMAC software on a laptop. Calibration was performed according to manufacturer guidelines. Participants stood with hands by their sides, without assisted devices. A sight target was taped to the wall. Participants stood quietly for one minute before testing.
Measured: at baseline and after 3 months
assessment of change of pediatric balance
The pediatric balance scale is a tool designed for children and adolescents aged five to 15 years to assess their static and dynamic balance. It consists of 14 items with scores ranging from 0 to 4, with a maximum score of 56. The scale has test-retest and interrater reliability of 0.998 and 0.997 in school-aged children with mild to moderate motor impairment. It requires minimal specialized equipment, such as an adjustable seat, chair, stopwatch, footrest, eraser, tape measure, and child-sized foot molds.
Measured: at baseline and after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start1 Jan 2023
- Primary completion1 Dec 2023
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Balance BoardStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeinab Mohamed Hassan Ewida, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06964386
- Sponsor's protocol ID
- Zeinab-004238
- Status last verified
- May 2025
- First submitted
- 1 May 2025
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Specially Designed Balance Board on Standing Balance in Children With Diplegic Cererbral Palsy
- ClinicalTrials.gov ID
- NCT06964386
- Acronym / sponsor ID
- Zeinab-004238
- Conditions
- Balance Board, Standing Balance, Diplegic Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 9 May 2025 (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 was done to:
- To determine the effect of a specially designed balance board on balance ability.
- To determine the effect of the traditional balance training program on balance ability.
- To compare between the effect of a specially designed balance board and the traditional balance training program on balance ability.
Detailed description
Children with cerebral palsy (CP) often experience abnormal posture, loss of motor control, and poor trunk control, leading to limitations in daily activities. Improving balance abilities is crucial for maintaining equilibrium in sensory environments. Vestibular stimulation can help develop feed-forward mechanisms and new functional skills. This study aims to improve balance abilities in children with diplegic CP, explore the impact of balance boards on vestibular and hand function, and assist mothers in their child's improvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the traditional program | Experimental | Other: The traditional physical therapy rehabilitation exercises, Other: balance training on traditional balance boardtwenty Children in group A received designed physical therapy program in addition to traditional balance training |
| balance training exercises | Active comparator | Other: The traditional physical therapy rehabilitation exercises, Other: program on special form of balance boardtwenty Children in group B received the same designed physical therapy program in addition to balance training exercises on special form of balance board |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Their ages ranged from 4 to 8 years old.
- The degree of spasticity ranged from grade 1 or 1+ according to Modified Ashworth Scale
- They were at level I or II on gross motor function classification scale.
- They were able to follow verbal command or instructions.
Key exclusion criteria (7 listed)
- Fixed deformities of lower limbs.
- Visual or auditory problems.
- History of surgical interference in lower limbs less than six months.
- Botulinum toxin injections to the lower limb during the previous 4 months.
- Mental retardation.
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 |
|---|---|---|
| The traditional physical therapy rehabilitation exercisesIt included 30 minutes of exercises as: * Incorporated stretching (adductors, calf, and hamstring muscles) * Range of motion for hip, knee, and ankle joints. * Core stability exercises. * climbing stairs and weight-bearing activities for strengthening, such as sit-to-stand and attaining standing position by half kneeling | Other | balance training exercises, the traditional program |
| balance training on traditional balance boardBalance training included: - Side stepping - Stepping backward - Changing the center of gravity in one-foot balance. | Other | the traditional program |
| program on special form of balance boardStanding holding on the sticks of balance board (first by two sticks, then graduated by one stick). 2- Changing the grasp of hand on sticks (reciprocal catching the sticks by right and left hand). 3- Stride standing on balance board. 4- Make exercises advanced by remove sticks and throwing the ball. 5- All previous exercises do with eye closed and eye opened | Other | balance training exercises |
Primary outcome
assessment of degree of spasticity
Time frame: at baseline and after 3 months
Assessment of tone involves the clinician passively moving the patient's joints slowly and quickly and rating the degree of resistance felt to rapid stretch, typically as increased or decreased relative to a presumed normal (Hugos and Cameron, 2019). Only spastic diplegic children with grade 1 and 1+ will be included in the study
3 secondary outcomes
Assessment of change of gross motor function level
Time frame: at baseline and after 3 months
assessment of change of balance
Time frame: at baseline and after 3 months
assessment of change of pediatric balance
Time frame: at baseline and after 3 months
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 9 May 2025.
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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 The traditional physical therapy rehabilitation exercises, balance training on traditional balance board and program on special form of balance board in people with Balance Board and Standing Balance, 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 7 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 9 May 2025. 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 degree of spasticity (time frame: at baseline and after 3 months). 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 9 May 2025.