Hemiplegic Cerebral PalsyNCT05068596
Effect of Loaded Functional Training on Hemiplegic Cerebral Palsy
A study testing expermintal in people with Hemiplegic Cerebral Palsy, run by Badr University at 1 site in Egypt.
Trial summary
weakness of lower limb is common in cp children Read more about this study
- Who is it for?
- Ages 10 to 12 years
- Conditions the study is for
- Hemiplegic Cerebral Palsy
- What is being tested?
- expermintal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Sep 2021to 15 Jan 2022
- 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 10 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age 10-12
- level I,II according to GMFCM
- Able to follow and understand instructions
Who cannot join
- visual and respiratory disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Loaded Functional Strength Training From a Plantigrade Foot Position Using Shoe Holder on Hip and Knee Extensors Strength and Function Walking Capacity in Children With Spastic Hemiplegic Cerebral Palsy
weakness of lower limb is common in cp children
- Conditions
- Hemiplegic Cerebral Palsy
- Being tested
- expermintal, CONTROL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
expermintalOther
progressive resistive functional strength training in the plantigrade foot position plus designed physical therapy program
CONTROLOther
Designed physical therapy program
| Study group | Role | What they receive |
|---|---|---|
| study groip | Experimental | received the designed physical therapy program as the control group. In addition, they received progressive resistive functional strength training in the plantigrade foot position. Receives: Other: expermintal |
| control group | Other | received a designed physical therapy program Receives: Other: CONTROL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength dynamometry
The gold standard for evaluating isometric muscle strength is the portable dynamometer
Measured: pre and post three month of intervention high score indicate improvement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start30 Sep 2021
- Primary completion31 Dec 2021
- Study completion15 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiplegic 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
- Participant
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Badr University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hanaa mohsen, Badr University
- Investigators
- Hanaa M Abd-Elfattah, ph.d, Principal investigator, lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05068596
- Sponsor's protocol ID
- hana 9
- Status last verified
- Feb 2022
- First submitted
- 12 Sep 2021
- Last updated
- 13 Apr 2022
- 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 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Loaded Functional Strength Training From a Plantigrade Foot Position Using Shoe Holder on Hip and Knee Extensors Strength and Function Walking Capacity in Children With Spastic Hemiplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05068596
- Acronym / sponsor ID
- hana 9
- Conditions
- Hemiplegic Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Badr UniversityUniversity, hospital or other
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 15 Jan 2022 (actual)
- First posted
- 6 Oct 2021 (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.
weakness of lower limb is common in cp children
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study groip | Experimental | Other: expermintalreceived the designed physical therapy program as the control group. In addition, they received progressive resistive functional strength training in the plantigrade foot position. |
| control group | Other | Other: CONTROLreceived a designed physical therapy program |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- age 10-12
- level I,II according to GMFCM
- Able to follow and understand instructions
Key exclusion criteria (1 listed)
- visual and respiratory disorder
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 |
|---|---|---|
| expermintalprogressive resistive functional strength training in the plantigrade foot position plus designed physical therapy program | Other | study groip |
| CONTROLDesigned physical therapy program | Other | control group |
Primary outcome
Muscle strength dynamometry
Time frame: pre and post three month of intervention high score indicate improvement
The gold standard for evaluating isometric muscle strength is the portable dynamometer
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 13 Apr 2022.
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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.
Hanaa M Abd-Elfattah, ph.d principal investigator
lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing expermintal in people with Hemiplegic Cerebral Palsy, run by Badr 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 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: finished, as of the sponsor's last update on 13 Apr 2022. 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?
Muscle strength dynamometry (time frame: pre and post three month of intervention high score indicate improvement). 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 13 Apr 2022.