Hemiplegic Cerebral PalsyAOPTNCT05875012
Effect of Action Observation Physical Training on Quality of Upper Limb and Functional Independence in Children With Hemiplegia
A study testing action observation physical training and Traditional physical therapy training in people with Hemiplegic Cerebral Palsy, run by Cairo University at 1 site in Egypt.
Trial summary
30 children with a diagnosis of hemiplegic cerebral palsy Read more about this study
- Who is it for?
- Ages 6 to 9 years
- Conditions the study is for
- Hemiplegic Cerebral Palsy
- What is being tested?
- action observation physical training and Traditional physical therapy training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Jul 2022to 17 Dec 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 6 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- manual ability classification system level II or III, Modified ashwarth scale 1+ or 2
Who cannot join
- visual or auditory problems ,fixed deformities
Trial locations and contacts
1 site in 1 country.
About this study
30 children with a diagnosis of hemiplegic cerebral palsy
Read the detailed description
children aged 6-9 years were randomized into 2 groups, control group and study group
- Conditions
- Hemiplegic Cerebral Palsy
- Being tested
- action observation physical training, Traditional physical therapy training
- Keywords
- HCP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
action observation physical trainingOther
Action observation training 3 sessions per week for 3 successive months
Traditional physical therapy trainingOther
Traditional physical therapy training 3 sessions per week for 3 successive months
| Study group | Role | What they receive |
|---|---|---|
| Action observation arm | Active comparator | Not described Receives: Other: action observation physical training |
| traditional physical training | Active comparator | Not described Receives: Other: Traditional physical therapy training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Upper Extremity skills test
reliable and valid scale,evaluate quality of upper extremity function in four domains dissociated movement,grasp,weight bearing and protective extension
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start18 Jul 2022
- Primary completion13 Nov 2022
- Study completion17 Dec 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.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Essam Abdelfattah, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05875012
- Sponsor's protocol ID
- Action observation training
- Acronym
- AOPT
- Status last verified
- May 2023
- First submitted
- 5 May 2023
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Action Observation Physical Training on Quality of Upper Limb and Functional Independence in Children With Hemiplegia
- ClinicalTrials.gov ID
- NCT05875012
- Acronym / sponsor ID
- AOPT / Action observation training
- Conditions
- Hemiplegic Cerebral Palsy
- Keywords
- HCP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 18 Jul 2022 (actual)
- Primary completion
- 13 Nov 2022 (actual)
- Study completion
- 17 Dec 2022 (actual)
- First posted
- 25 May 2023 (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.
30 children with a diagnosis of hemiplegic cerebral palsy
Detailed description
children aged 6-9 years were randomized into 2 groups, control group and study group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Action observation arm | Active comparator | Other: action observation physical training |
| traditional physical training | Active comparator | Other: Traditional physical therapy training |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- manual ability classification system level II or III, Modified ashwarth scale 1+ or 2
Key exclusion criteria (1 listed)
- visual or auditory problems ,fixed deformities
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 |
|---|---|---|
| action observation physical trainingAction observation training 3 sessions per week for 3 successive months | Other | Action observation arm |
| Traditional physical therapy trainingTraditional physical therapy training 3 sessions per week for 3 successive months | Other | traditional physical training |
Primary outcome
Quality of Upper Extremity skills test
Time frame: 3 months
reliable and valid scale,evaluate quality of upper extremity function in four domains dissociated movement,grasp,weight bearing and protective extension
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 25 May 2023.
- 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 action observation physical training and Traditional physical therapy training in people with Hemiplegic Cerebral Palsy, 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 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: finished, as of the sponsor's last update on 25 May 2023. 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?
Quality of Upper Extremity skills test (time frame: 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 25 May 2023.