Cerebral PalsyNCT06721650
Perturbation-Based Balance Training on Trunk Proprioception and Balance in Cerebral Palsy:
A study testing Perturbation-Based Balance Training and the selected physical therapy exercise program in people with Cerebral Palsy, run by Lama Saad El-Din Mahmoud at 1 site in Egypt.
Trial summary
To investigate the effect of Perturbation-Based Balance Training on trunk proprioception and balance in hemiparetic cerebral palsy Read more about this study
- Who is it for?
- Ages 8 to 10 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Perturbation-Based Balance Training and the selected physical therapy exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2024to 30 May 2025
- 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 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- - Thirty-eight children hemiplegic cerebral palsy
- Age will range as (8:10) years old
- Spastic hemiplegic cerebral palsy
- Normal body mass index ranged from 1SD to -2SDaccording to BMI-for age Z score charts include an age and sex- specific BMI for children (WHO, 2007).
- Gross motor function classification system: level I\&II
Who cannot join
- • Difficulty to communicate or to understand program instructions
- any other neurological deficits or orthopaedic abnormalities,
- secondary musculoskeletal complication
- vestibular problems
- any mental impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Perturbation-Based Balance Training on Trunk Proprioception and Balance in Hemiplegic Cerebral Palsy: a Randomized Controlled Trial
To investigate the effect of Perturbation-Based Balance Training on trunk proprioception and balance in hemiparetic cerebral palsy
Read the detailed description
Thirty-eight patients with hemiplegic cerebral palsy will participate in this study.
The patients will randomly be divided into two equal groups; the control group which received the selected physical therapy exercise program and the study group received the same exercise training program in addition to Perturbation-Based Balance Training, three times per week for three months. The evaluation methods are BIODEX, The Pediatric Balance Scale, baseline digital inclinometer.
- Conditions
- Cerebral Palsy
- Being tested
- Perturbation-Based Balance Training, the selected physical therapy exercise program
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perturbation-Based Balance TrainingOther
Perturbation-based balance training (PBT; or reactive balance training or perturbation training) is balance training that uses repeated, externally applied mechanical perturbations to trigger rapid reactions to regain postural stability in a safe and controlled environment
the selected physical therapy exercise programOther
trunk control therapeutic exercise, static and dynamic balance treaining exercises
| Study group | Role | What they receive |
|---|---|---|
| study group | Other | Not described Receives: Other: Perturbation-Based Balance Training; Other: the selected physical therapy exercise program |
| control group | Other | Not described Receives: Other: the selected physical therapy exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
BIODEX balance system
to evaluate postural balance. The BBS is a multiaxial device that objectively measures and records an individual's ability to stabilize the involved joint under dynamic stress.
Measured: three months
Pediatric Balance Scale
The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills in school-aged children. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points
Measured: three months
baseline digital inclinometer.
for measuring lateral movement in applications like: Earth movement in the landslide zone. Detecting shear planes in hydraulic structures. Measuring stability during construction
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start15 Dec 2024
- Primary completion30 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lama Saad El-Din Mahmoud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lama Saad El-Din Mahmoud, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06721650
- Sponsor's protocol ID
- P.T.REC/012/005471
- Status last verified
- Jan 2026
- First submitted
- 3 Dec 2024
- Last updated
- 30 Jan 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 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Perturbation-Based Balance Training on Trunk Proprioception and Balance in Hemiplegic Cerebral Palsy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06721650
- Acronym / sponsor ID
- P.T.REC/012/005471
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Lama Saad El-Din MahmoudUniversity, hospital or other
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 6 Dec 2024 (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.
To investigate the effect of Perturbation-Based Balance Training on trunk proprioception and balance in hemiparetic cerebral palsy
Detailed description
Thirty-eight patients with hemiplegic cerebral palsy will participate in this study.
The patients will randomly be divided into two equal groups; the control group which received the selected physical therapy exercise program and the study group received the same exercise training program in addition to Perturbation-Based Balance Training, three times per week for three months. The evaluation methods are BIODEX, The Pediatric Balance Scale, baseline digital inclinometer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Other | Other: Perturbation-Based Balance Training, Other: the selected physical therapy exercise program |
| control group | Other | Other: the selected physical therapy exercise program |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- - Thirty-eight children hemiplegic cerebral palsy
- Age will range as (8:10) years old
- Spastic hemiplegic cerebral palsy
- Normal body mass index ranged from 1SD to -2SDaccording to BMI-for age Z score charts include an age and sex- specific BMI for children (WHO, 2007).
- Gross motor function classification system: level I\&II
Key exclusion criteria (5 listed)
- • Difficulty to communicate or to understand program instructions
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 |
|---|---|---|
| Perturbation-Based Balance TrainingPerturbation-based balance training (PBT; or reactive balance training or perturbation training) is balance training that uses repeated, externally applied mechanical perturbations to trigger rapid reactions to regain postural stability in a safe and controlled environment | Other | study group |
| the selected physical therapy exercise programtrunk control therapeutic exercise, static and dynamic balance treaining exercises | Other | control group, study group |
Primary outcome
BIODEX balance system
Time frame: three months
to evaluate postural balance. The BBS is a multiaxial device that objectively measures and records an individual's ability to stabilize the involved joint under dynamic stress.
Pediatric Balance Scale
Time frame: three months
The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills in school-aged children. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points
baseline digital inclinometer.
Time frame: four weeks
for measuring lateral movement in applications like: Earth movement in the landslide zone. Detecting shear planes in hydraulic structures. Measuring stability during construction
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 30 Jan 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 Perturbation-Based Balance Training and the selected physical therapy exercise program in people with Cerebral Palsy, run by Lama Saad El-Din Mahmoud 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 5 inclusion and 5 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 30 Jan 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?
BIODEX balance system (time frame: three months). The study lists 3 primary outcomes in all. 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 30 Jan 2026.