Ataxic Cerebral PalsyNCT05227066
Efficacy of Adding Lower Extremity Weights on Balance in Children With Ataxic Cerebral Palsy
A study testing adding lower extremity weights and traditional physical therapy group in people with Ataxic Cerebral Palsy, run by Delta University for Science and Technology at 1 site in Egypt.
Trial summary
Ataxic CP is one type of cerebral palsy. children with ataxic cerebral palsy have trouble with balance and coordination. They may walk with their legs farther apart than other kids and have a hard time with activities that use small hand movements, like writing. Read more about this study
- Who is it for?
- Ages 7 to 13 years
- Conditions the study is for
- Ataxic Cerebral Palsy
- What is being tested?
- adding lower extremity weights and traditional physical therapy group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jan 2025to 20 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 7 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ataxic cerebral palsy aged 7-13 years
Who cannot join
- any musculoskeletal conditions that affect balance previous surgeries that affecting balance
Trial locations and contacts
1 site in 1 country.
About this study
Ataxic CP is one type of cerebral palsy. children with ataxic cerebral palsy have trouble with balance and coordination. They may walk with their legs farther apart than other kids and have a hard time with activities that use small hand movements, like writing. Some also have trouble with depth perception This means being able to accurately judge how close or far away something is
- Conditions
- Ataxic Cerebral Palsy
- Being tested
- adding lower extremity weights, traditional physical therapy group
- Medical subject headings
- Cerebral Palsy, Ataxic, Autosomal Recessive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adding lower extremity weightsOther
All children in the two groups received physical therapy protocol for 30 minutes in addition to half kg of sandbags weights attached for each leg
traditional physical therapy groupOther
traditional physical therapy group
| Study group | Role | What they receive |
|---|---|---|
| traditional physical therapy group | Experimental | received traditional physical therapy protocol Receives: Other: traditional physical therapy group |
| lower extremity weights group | Experimental | received the same traditional physical therapy in addition to lower extremity weights Receives: Other: adding lower extremity weights; Other: traditional physical therapy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in overall stability index
change in overall stability index will measured by using biodex balance system
Measured: baseline and after 3 months of intervention.
Secondary outcomes (2)
antero-posterior stability index
change in antero-posterior stability index will measured by using biodex balance system
Measured: baseline and after 3 months of intervention.
mediolateral stability index
change in mediolateral stability index will measured by using biodex balance system
Measured: baseline and after 3 months of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start5 Jan 2025
- Primary completion15 Dec 2025 (estimated)
- Study completion20 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ataxic 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Delta University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, walaa eldesoukey heneidy, Delta University for Science and Technology
- Investigators
- Hala I. Kassem, Professor, Study director, Professor of physical therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05227066
- Sponsor's protocol ID
- Ataxic CP
- Status last verified
- Dec 2024
- First submitted
- 6 Jan 2022
- Last updated
- 18 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Adding Lower Extremity Weights on Balance in Children With Ataxic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05227066
- Acronym / sponsor ID
- Ataxic CP
- Conditions
- Ataxic Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Delta University for Science and TechnologyUniversity, hospital or other
- Study start
- 5 Jan 2025 (actual)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 7 Feb 2022 (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.
Ataxic CP is one type of cerebral palsy. children with ataxic cerebral palsy have trouble with balance and coordination. They may walk with their legs farther apart than other kids and have a hard time with activities that use small hand movements, like writing. Some also have trouble with depth perception This means being able to accurately judge how close or far away something is
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| traditional physical therapy group | Experimental | Other: traditional physical therapy groupreceived traditional physical therapy protocol |
| lower extremity weights group | Experimental | Other: adding lower extremity weights, Other: traditional physical therapy groupreceived the same traditional physical therapy in addition to lower extremity weights |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- ataxic cerebral palsy aged 7-13 years
Key exclusion criteria (1 listed)
- any musculoskeletal conditions that affect balance previous surgeries that affecting balance
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 |
|---|---|---|
| adding lower extremity weightsAll children in the two groups received physical therapy protocol for 30 minutes in addition to half kg of sandbags weights attached for each leg | Other | lower extremity weights group |
| traditional physical therapy grouptraditional physical therapy group | Other | lower extremity weights group, traditional physical therapy group |
Primary outcome
Change in overall stability index
Time frame: baseline and after 3 months of intervention.
change in overall stability index will measured by using biodex balance system
2 secondary outcomes
antero-posterior stability index
Time frame: baseline and after 3 months of intervention.
mediolateral stability index
Time frame: baseline and after 3 months of intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: Yes
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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.
Hala I. Kassem, Professor study director
Professor of physical therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing adding lower extremity weights and traditional physical therapy group in people with Ataxic Cerebral Palsy, run by Delta University for Science and Technology 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 18 Dec 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in overall stability index (time frame: baseline and after 3 months of intervention.). 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 18 Dec 2025.