Facial ParalysisNCT04215562
Outcome of Facial Palsy Following Rehabilitation
A study testing rehabilitation in people with Facial Paralysis, run by University of Alexandria at 1 site in Egypt.
Trial summary
Retrospective case series,the aim of this study is to assess the outcome and rate of complications in patients with facial palsy following rehabilitation, a retrospective study. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Facial Paralysis
- What is being tested?
- rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2020to 1 Mar 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- all patients with primary idiopathic peripheral facial palsy
Who cannot join
- all patients with secondary causes of facial palsy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcome and Complications of Peripheral Facial Palsy Following Rehabilitation: A Retrospective Study
Retrospective case series,the aim of this study is to assess the outcome and rate of complications in patients with facial palsy following rehabilitation, a retrospective study.
Read the detailed description
Data from all patients presenting to the outpatient clinics of the Physical Medicine, Rheumatology and Rehabilitation Department. Faculty of Medicine, Alexandria University in the past 3 years will be collected. The outcome and complications from rehabilitation of facial palsy will be recorded.
Primary Outcome: complications of Facial palsy following rehabilitation. Confidentiality of all records will be ensured.
- Conditions
- Facial Paralysis
- Being tested
- rehabilitation
- Medical subject headings
- Facial Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rehabilitationCombination product
electro-therapy, heat therapy, massage and exercise therapy
| Study group | Role | What they receive |
|---|---|---|
| patients with peripheral facial palsy | Other | collection of data from records on the outcome of rehabilitation therapy on patients with peripheral facial palsy and types of complications associated with this therapy type Receives: Combination Product: rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
prognosis or outcome of therapy
have patients recovered fully, partially or did not recover
Measured: 3-6 months
complications
types of complications developed during rehabilitation
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start1 Jan 2020
- Primary completion30 Dec 2022 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial ParalysisStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alexandria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yousra Hisham Abdel Fattah, University of Alexandria
- Investigators
- Yousra Hisham A Fattah, Principal investigator, Alexandria University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04215562
- Sponsor's protocol ID
- 0304299
- Status last verified
- May 2022
- First submitted
- 29 Dec 2019
- Last updated
- 26 May 2022
- Results posted
- 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 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome and Complications of Peripheral Facial Palsy Following Rehabilitation: A Retrospective Study
- ClinicalTrials.gov ID
- NCT04215562
- Acronym / sponsor ID
- 0304299
- Conditions
- Facial Paralysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of AlexandriaUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 2 Jan 2020 (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.
Retrospective case series,the aim of this study is to assess the outcome and rate of complications in patients with facial palsy following rehabilitation, a retrospective study.
Detailed description
Data from all patients presenting to the outpatient clinics of the Physical Medicine, Rheumatology and Rehabilitation Department. Faculty of Medicine, Alexandria University in the past 3 years will be collected. The outcome and complications from rehabilitation of facial palsy will be recorded.
Primary Outcome: complications of Facial palsy following rehabilitation. Confidentiality of all records will be ensured.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with peripheral facial palsy | Other | Combination Product: rehabilitationcollection of data from records on the outcome of rehabilitation therapy on patients with peripheral facial palsy and types of complications associated with this therapy type |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all patients with primary idiopathic peripheral facial palsy
Key exclusion criteria (1 listed)
- all patients with secondary causes of facial palsy
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 |
|---|---|---|
| rehabilitationelectro-therapy, heat therapy, massage and exercise therapy | Combination product | patients with peripheral facial palsy |
Primary outcome
prognosis or outcome of therapy
Time frame: 3-6 months
have patients recovered fully, partially or did not recover
complications
Time frame: 3-6 months
types of complications developed during rehabilitation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
- 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.
Yousra Hisham A Fattah principal investigator
Alexandria University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rehabilitation in people with Facial Paralysis, run by University of Alexandria 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: status not confirmed, as of the sponsor's last update on 26 May 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?
Results are not available in the source record.
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?
prognosis or outcome of therapy (time frame: 3-6 months). 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?
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 26 May 2022.