Cerebral Palsy (CP)NCT06750081
Cross-Training and Locomotor Abilities in Cerebral Palsy
A study testing Physical Therapy and Designed rehabilitation program in people with Cerebral Palsy (CP) and Spastic Hemiparesis, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose was to investigate the effect of cross-training as a method of unilateral motor priming on locomotor abilities in children with spastic unilateral cerebral palsy. Read more about this study
- Who is it for?
- Ages 6 to 8 years
- Conditions the study is for
- Cerebral Palsy (CP), Spastic Hemiparesis
- What is being tested?
- Physical Therapy and Designed rehabilitation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2023to 15 Dec 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 6 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Spasticity grade 1 to 1+, according to the Modified Ashworth Scale.
- Can stand and walk autonomously.
- Able to follow verbal commands and instructions.
Who cannot join
- Fixed musculoskeletal deformities
- significant cognitive disorders
- significant perceptual disorders
- significant auditory disorders
- significant visual disorders
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Physical Therapy, Cairo University
Giza, Cairo Governorate, 12613
About this study
Official title: Effect of Cross-Training on Locomotor Abilities in Children with Spastic Hemiparesis
The purpose was to investigate the effect of cross-training as a method of unilateral motor priming on locomotor abilities in children with spastic unilateral cerebral palsy.
Read the detailed description
Thirty children with spastic unilateral cerebral palsy were recruited from different rehabilitation centers. They were assigned randomly into two groups. Children in the control group (A) were engaged in a selected physical therapy program while those in the experimental group (B) received cross-training program followed by application of the same selected physical therapy program received by group (A). The treatment programs were conducted five times per week for six successive weeks. Measurements obtained included active ankle dorsiflexion range of motion (AROM), and the speed of walking obtained by 10-meter walking test. These measures were recorded two times: pre- and post-treatment.
- Conditions
- Cerebral Palsy (CP), Spastic Hemiparesis
- Being tested
- Physical Therapy, Designed rehabilitation program
- Medical subject headings
- Cerebral Palsy, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical TherapyOther
Exercises to improve locomotor abilities of children with CP
Designed rehabilitation programOther
Program of exercises to enhance abilities
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | receive an experimental intervention Receives: Other: Designed rehabilitation program |
| Control | Active comparator | another therapy used to treat the same condition Receives: Other: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
active ankle dorsiflexion range of motion (AROM)
Measured: Baseline and at the end - through study completion, an average of 1 year
10-meter walking test
Measured: Baseline and at the end - through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start1 Aug 2023
- Primary completion1 Dec 2024
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral Palsy (CP)Studies 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, Tamer Mohamed El-Saeed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06750081
- Sponsor's protocol ID
- P.T.REC/012/004588
- Status last verified
- Dec 2024
- First submitted
- 15 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Peterson MD, Lukasik L, Muth T, Esposito P, Haapala H, Gordon PM, IglayReger H, Hurvitz EA. Recumbent cross-training is a feasible and safe mode of physical activity for significantly motor-impaired adults with cerebral palsy. Arch Phys Med Rehabil. 2013 Feb;94(2):401-7. doi: 10.1016/j.apmr.2012.09.027. Epub 2012 Oct 10.
PubMed 23063881
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cross-Training on Locomotor Abilities in Children with Spastic Hemiparesis
- ClinicalTrials.gov ID
- NCT06750081
- Acronym / sponsor ID
- P.T.REC/012/004588
- Conditions
- Cerebral Palsy (CP), Spastic Hemiparesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 27 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.
The purpose was to investigate the effect of cross-training as a method of unilateral motor priming on locomotor abilities in children with spastic unilateral cerebral palsy.
Detailed description
Thirty children with spastic unilateral cerebral palsy were recruited from different rehabilitation centers. They were assigned randomly into two groups. Children in the control group (A) were engaged in a selected physical therapy program while those in the experimental group (B) received cross-training program followed by application of the same selected physical therapy program received by group (A). The treatment programs were conducted five times per week for six successive weeks. Measurements obtained included active ankle dorsiflexion range of motion (AROM), and the speed of walking obtained by 10-meter walking test. These measures were recorded two times: pre- and post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Designed rehabilitation programreceive an experimental intervention |
| Control | Active comparator | Other: Physical Therapyanother therapy used to treat the same condition |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Spasticity grade 1 to 1+, according to the Modified Ashworth Scale.
- Can stand and walk autonomously.
- Able to follow verbal commands and instructions.
Key exclusion criteria (5 listed)
- Fixed musculoskeletal deformities
- significant cognitive disorders
- significant perceptual disorders
- significant auditory disorders
- significant visual disorders
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 |
|---|---|---|
| Physical TherapyExercises to improve locomotor abilities of children with CP | Other | Control |
| Designed rehabilitation programProgram of exercises to enhance abilities | Other | Experimental |
Primary outcome
active ankle dorsiflexion range of motion (AROM)
Time frame: Baseline and at the end - through study completion, an average of 1 year
10-meter walking test
Time frame: Baseline and at the end - through study completion, an average of 1 year
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 Dec 2024.
- Background: PubMed 23063881Peterson MD, Lukasik L, Muth T, Esposito P, Haapala H, Gordon PM, IglayReger H, Hurvitz EA. Recumbent cross-training is a feasible and safe mode of physical activity for significantly motor-impaired adults with cerebral palsy. Arch Phys Med Rehabil. 2013 Feb;94(2):401-7. doi: 10.1016/j.apmr.2012.09.027. Epub 2012 Oct 10.
- Individual participant dataSharing planned: No
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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 Physical Therapy and Designed rehabilitation program in people with Cerebral Palsy (CP) and Spastic Hemiparesis, 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 3 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 27 Dec 2024. 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?
active ankle dorsiflexion range of motion (AROM) (time frame: Baseline and at the end - through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06750081, which also lists 1 linked publication.
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 Dec 2024.