Facial ParalysisNCT00989209
Myofunctional Therapy in Facial Palsy
A study testing Botulinum Toxin Type A and myofunctional therapy in people with Facial Paralysis, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Objective: Quantify the benefits of myofunctional therapy associated to botulinum toxin injection in patients with long standing facial unilateral palsy. Read more about this study
- Who is it for?
- Ages 16 to 62 yearsHealthy volunteers can take part
- Conditions the study is for
- Facial Paralysis
- What is being tested?
- Botulinum Toxin Type A and myofunctional therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2005to Dec 2006
- 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 16 to 62 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- facial paralysis with more than 2 years elapsed since the onset of symptoms
- surgically treated for reanimation at least 12 months before
- static and/or dynamic facial asymmetry causing aesthetic concern
Who cannot join
- spastic paralysis
- serious systemic or neuromuscular diseases
- cognition impairment
- pregnant women
Trial locations and contacts
1 site in 1 country.
Brazil1 site
University of Sao Paulo General Hospital
São Paulo, São Paulo, 05403-000
About this study
Official title: Improvement of Facial Symmetry With Myofunctional Therapy Combined to Botulinum Toxin Injections in Long Standing Facial Paralysis
Objective: Quantify the benefits of myofunctional therapy associated to botulinum toxin injection in patients with long standing facial unilateral palsy.
Read the detailed description
Twenty-five patients with long standing facial palsy were studied; all had been previously treated for facial reanimation. Patients were randomly divided in two groups; Group A did the myofunctional therapy sessions with the speech therapist before the botulinum toxin injection, while the participants of Group B did the myofunctional therapy after it.
- Conditions
- Facial Paralysis
- Being tested
- Botulinum Toxin Type A, myofunctional therapy
- Keywords
- facial paralysis, asymmetry, myofunctional therapy, botulinum toxin, facial evaluation
- Medical subject headings
- Facial Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called BOTOX (Allergan)
All the patients received a one-time treatment with botulinum toxin type A to the non-paralyzed side, according to the Institution Protocol,the total dose used per patient ranged from 15-69U, mean 37.9±5.4U.
myofunctional therapyProcedure or surgery
All the patients were submitted to individual myofunctional therapy with the speech therapist, once a week, by four weeks.The myofunctional therapy began with isometric maneuvers for muscular elongation on the non paralyzed side, and on the paralyzed side when microsurgical reconstruction was present. It also included isotonic maneuvers to increase muscle tonus and isokinetic maneuvers to increase force on the paralyzed side.
| Study group | Role | What they receive |
|---|---|---|
| A: myofunctional prior to botulinum | Active comparator | All the facial paralysis patients received treatment with botulinum toxin type A to the non-paralyzed side, according to the Institution Protocol. To the participants of Group A, botulinum toxin was applied after myofunctional therapy. Receives: Drug: Botulinum Toxin Type A; Procedure: myofunctional therapy |
| B: myofunctional after botulinum | Active comparator | All the facial paralysis patients received treatment with botulinum toxin type A to the non-paralyzed side, according to the Institution Protocol. To the participants of Group B, botulinum toxin was applied before myofunctional therapy. Receives: Drug: Botulinum Toxin Type A; Procedure: myofunctional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical score
Measured: 2 months
Secondary outcomes (1)
Facial Disability Index (self-report instrument)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2009 (estimated)
- Study startJan 2005
- Primary completionDec 2005
- Study completionDec 2006
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 Facial ParalysisStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Alessandra G Salles, Study director, University of Sao Paulo General HospitalMarcus C Ferreira, Study chair, University of Sao Paulo General HospitalPaula N Toledo, Principal investigator, University of Sao Paulo General HospitalClaudia F Andrade, Study director, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00989209
- Sponsor's protocol ID
- CAPPesq 890/04
- Status last verified
- Oct 2009
- First submitted
- 2 Oct 2009
- Last updated
- 5 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Salles AG, Toledo PN, Ferreira MC. Botulinum toxin injection in long-standing facial paralysis patients: improvement of facial symmetry observed up to 6 months. Aesthetic Plast Surg. 2009 Jul;33(4):582-90. doi: 10.1007/s00266-009-9337-9. Epub 2009 Mar 28.
PubMed 19330369
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Facial Symmetry With Myofunctional Therapy Combined to Botulinum Toxin Injections in Long Standing Facial Paralysis
- ClinicalTrials.gov ID
- NCT00989209
- Acronym / sponsor ID
- CAPPesq 890/04
- Conditions
- Facial Paralysis
- Keywords
- facial paralysis, asymmetry, myofunctional therapy, botulinum toxin, facial evaluation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 5 Oct 2009 (estimated)
- 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.
Objective: Quantify the benefits of myofunctional therapy associated to botulinum toxin injection in patients with long standing facial unilateral palsy.
Detailed description
Twenty-five patients with long standing facial palsy were studied; all had been previously treated for facial reanimation. Patients were randomly divided in two groups; Group A did the myofunctional therapy sessions with the speech therapist before the botulinum toxin injection, while the participants of Group B did the myofunctional therapy after it.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: myofunctional prior to botulinum | Active comparator | Drug: Botulinum Toxin Type A, Procedure: myofunctional therapyAll the facial paralysis patients received treatment with botulinum toxin type A to the non-paralyzed side, according to the Institution Protocol. To the participants of Group A, botulinum toxin was applied after myofunctional therapy. |
| B: myofunctional after botulinum | Active comparator | Drug: Botulinum Toxin Type A, Procedure: myofunctional therapyAll the facial paralysis patients received treatment with botulinum toxin type A to the non-paralyzed side, according to the Institution Protocol. To the participants of Group B, botulinum toxin was applied before myofunctional therapy. |
Who may qualify
- Ages
- 16 to 62 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- facial paralysis with more than 2 years elapsed since the onset of symptoms
- surgically treated for reanimation at least 12 months before
- static and/or dynamic facial asymmetry causing aesthetic concern
Key exclusion criteria (4 listed)
- spastic paralysis
- serious systemic or neuromuscular diseases
- cognition impairment
- pregnant women
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 |
|---|---|---|
| Botulinum Toxin Type AAlso: BOTOX (Allergan)All the patients received a one-time treatment with botulinum toxin type A to the non-paralyzed side, according to the Institution Protocol,the total dose used per patient ranged from 15-69U, mean 37.9±5.4U. | Drug | A: myofunctional prior to botulinum, B: myofunctional after botulinum |
| myofunctional therapyAll the patients were submitted to individual myofunctional therapy with the speech therapist, once a week, by four weeks.The myofunctional therapy began with isometric maneuvers for muscular elongation on the non paralyzed side, and on the paralyzed side when microsurgical reconstruction was present. It also included isotonic maneuvers to increase muscle tonus and isokinetic maneuvers to increase force on the paralyzed side. | Procedure or surgery | A: myofunctional prior to botulinum, B: myofunctional after botulinum |
Primary outcome
Clinical score
Time frame: 2 months
1 secondary outcome
Facial Disability Index (self-report instrument)
Time frame: 2 months
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 5 Oct 2009.
- Background: PubMed 19330369Salles AG, Toledo PN, Ferreira MC. Botulinum toxin injection in long-standing facial paralysis patients: improvement of facial symmetry observed up to 6 months. Aesthetic Plast Surg. 2009 Jul;33(4):582-90. doi: 10.1007/s00266-009-9337-9. Epub 2009 Mar 28.
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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.
Alessandra G Salles study director
University of Sao Paulo General Hospital
Marcus C Ferreira study chair
University of Sao Paulo General Hospital
Paula N Toledo principal investigator
University of Sao Paulo General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botulinum Toxin Type A and myofunctional therapy in people with Facial Paralysis, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 4 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 5 Oct 2009. 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 Brazil. 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?
Clinical score (time frame: 2 months). 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 NCT00989209, 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 5 Oct 2009.