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Trial registered on ANZCTR


Registration number
ACTRN12621001262897p
Ethics application status
Submitted, not yet approved
Date submitted
20/07/2021
Date registered
17/09/2021
Date last updated
17/09/2021
Date data sharing statement initially provided
17/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
An investigation into the feasibility of implementing facial taping for adults with central facial palsy via a combined telehealth model: a nonrandomized control trial.
Scientific title
An investigation into the feasibility of implementing facial taping for adults with central facial palsy via a combined telehealth model: a nonrandomized control trial.
Secondary ID [1] 304825 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Central Facial Palsy 322906 0
Condition category
Condition code
Physical Medicine / Rehabilitation 320485 320485 0 0
Speech therapy
Neurological 320716 320716 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Facial taping (application of Leukofix tape to facial structures)

Description:
Following pre-assessment, participants in the treatment arm will apply facial taping daily as per standardized instructions (developed for this study) which will be provided in multiple modalities (e.g., written, photographic, and video resources). Video resources will consist of 1 x 5 min video containing generic taping instructions to be used by all participants, with 3 x 5 min short clips for various strip placements. Written instructions and photographs will be personalized for each participant, using images collected during the initial face-to-face instruction session. Written instructions will consist of a 2–3-page document with 3-5 written steps and approximately 3-5 photographs of tape on the participants face, which will be reviewed for reference only as needed.

Participants will initially receive 2 x 20min face-to-face instruction sessions on consecutive days with an experienced speech pathologist (Coordinating Principal Investigator) where they (or their SO) will be trained in application of the taping. Subsequent application of the taping protocol will be performed by the patient and their significant other and will continue for 3 weeks (7 days per week). Daily application of tape is anticipated to take approximately 5 minutes, and the tape will remain insitu across the day unless removal is indicated (e.g., significant discomfort or skin irritation is experienced by the participant).

Participants will receive a morning SMS reminder to apply the tape, and of the time that they will receive an afternoon video call on relevant days. This reminder will prompt the participants to review the instructional material as needed prior to removal and/or application of the tape. Review of the tape application (15-20 min) will be provided on relevant days by the PI either via face-to-face contact during admission to GCUH or video call if participants are discharged from hopsital or admitted to a PAH acute or rehabilitation ward. Participants will also receive a 1 x 30-60 min face-to-face review session with the CPI weekly if indicated or requested. Review by the PI will be used for skin integrity monitoring and evaluation of treatment fidelity).

As this is a nonrandomised feasibility study, all participants from GCUH and PAH will be recruited to the treatment arm and all participants from ACH will be recruited to the control arm.
Intervention code [1] 321203 0
Treatment: Devices
Intervention code [2] 321204 0
Rehabilitation
Comparator / control treatment
Participants who are recruited at the Auckland Hospital site will receive usual speech pathology interventions, which include a range of therapies addressing speech and language impairments resulting from stroke.

Usual care in speech pathology for facial palsy varies depending on health service and individual clinician skill level, and often does not include any therapy specifically targeting this impairment, which is a significant gap identified in current evidence and practice (Vaughan, A., Copley, A. and Miles, A. Physical rehabilitation of central facial palsy: A survey of current multidisciplinary practice. Submitted to International Journal of Speech-Language Pathology, In peer review.).
Control group
Active

Outcomes
Primary outcome [1] 328312 0
Change in facial movement / function as measured using the 'Sunnybrook' Facial Grading System (Ross et al, 1996),
Timepoint [1] 328312 0
3 weeks post intervention and 1 month follow-up
Secondary outcome [1] 400305 0
Percentage of participants recruited to the trial who completed the protocol as planned.
Timepoint [1] 400305 0
At completion of 3 assessment points (baseline, 3 weeks post intervention, 1 month follow-up).

Eligibility
Key inclusion criteria
- Adult (i.e. over 18 years of age)
- New-onset facial palsy diagnosed by a speech pathologist (SP); resulting from damage to central nervous system (e.g., stroke or acquired brain injury); persisting 72 hours post hospital admission.
- Residing within 50km from either tertiary hospital site;
- Does not present with a current significant cognitive impairment; intellectual impairment or mental illness that precludes participation in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Previous or chronic facial palsy (central or peripheral);
- History of progressive neurological disorders (e.g. dementia, Parkinson’s disease) or currently in post-traumatic amnesia as documented in the patient’s medical record;
- Documented lack of capacity to consent as per medical record;
- Allergies or skin integrity concerns (as documented within the electronic medical record) that would preclude participation in a protocol involving adhesives and adhesive removers;
- Participants who do not have a significant other available to assist with tape application and lack the dexterity to apply tape independently;
- Participants who are unable or unwilling to maintain a clean-shaven face for the duration of the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
This is a nonrandomised pilot and feasibility study which will consist of two study arms; a treatment arm consisting of participants recruited from GCUH and PAH sites, and a control arm recruited from ACH.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As per the CONSORT extension for pilot and feasibility studies, sample size calculations and inferential statistics are not indicated. Based on clinical data (number of stroke admissions to GCUH presenting with central facial palsy over 12 months) and an estimated 60-70% consent rate from previous related clinical research, recruitment of 30 participants per group was expected to take approximately 12-18 months. There is no guidance in the current literature relating to central facial palsy that provides realistic sample size data specific to this patient population with this type of intervention. Therefore sample size calculation also incorporated literature pertaining to feasibility studies more generally and reflects the median sample size per arm reported in the United Kingdom Clinical Research Network database.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2021
Actual
Date of last participant enrolment
Anticipated
31/10/2023
Actual
Date of last data collection
Anticipated
31/12/2023
Actual
Sample size
Target
68
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 20028 0
Gold Coast University Hospital - Southport
Recruitment hospital [2] 20029 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 34736 0
4215 - Southport
Recruitment postcode(s) [2] 34737 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 23977 0
New Zealand
State/province [1] 23977 0
Auckland

Funding & Sponsors
Funding source category [1] 309198 0
Hospital
Name [1] 309198 0
Gold Coast Hospital and Health Service
Country [1] 309198 0
Australia
Funding source category [2] 309372 0
Hospital
Name [2] 309372 0
Princess Alexandra Hospital
Country [2] 309372 0
Australia
Primary sponsor type
Hospital
Name
Gold Coast Hospital and Health Service
Address
Gold Coast University Hospital
1 Hospital Blvd
Southport QLD 4215
Country
Australia
Secondary sponsor category [1] 310158 0
None
Name [1] 310158 0
Address [1] 310158 0
Country [1] 310158 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 309052 0
Gold Coast Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 309052 0
Gold Coast University Hospital,
Level 2 Pathology and Education Building,
1 Hospital Boulevard, Southport, QLD 4215
Ethics committee country [1] 309052 0
Australia
Date submitted for ethics approval [1] 309052 0
19/07/2021
Approval date [1] 309052 0
Ethics approval number [1] 309052 0

Summary
Brief summary
The overall aim of this project is to investigate the feasibility of implementing facial taping via a hybrid model of care (in-person and telehealth) to inform the design of a larger randomized control effectiveness trial. This is a nonrandomised pilot and feasibility study which will consist of two study arms; a treatment arm consisting of participants recruited from GCUH and PAH sites, and a control arm recruited from ACH. Several validated assessment tools will be used to define facial palsy. Recruitment to the treatment arm will be of adults with central facial palsy resulting from stroke who reside within 50km from either tertiary hospital site and meet inclusion criteria; 6-8 speech pathologists working either PAH or GCUH. Following recruitment and consent, baseline assessment will be performed with all participants (treatment arm and control arm). Participants in the treatment arm (and significant others where applicable) will then receive training in the application of facial taping. The facial taping will be applied daily for three weeks with guidance provided by an experienced speech pathologist via a combined telehealth model. The assessment battery will be repeated at the conclusion of the intervention period and at a month following this timepoint. In addition, participants will be interviewed at both post-intervention timepoints. Significant others will also be interviewed at the conclusion of the intervention period. Speech pathologists involved in the care of participants will be invited to participate in a focus group at the end of recruitment. Data collection for the research questions addressed in each study will be undertaken concurrently across a range of focus areas including:
- Appropriateness of recruitment methods;
- Suitability of assessment tools, data collection procedures, and outcome measures;
- Acceptability of assessment and intervention protocols;
- Adherence to intervention protocol;
- Measurement of health resource utilization and service impact (e.g., cost benefit analysis);
- Preliminary impact of intervention on participants.
Feasibility outcome measures have been developed from relevant literature. Data will be analysed using a combination of descriptive statistics and qualitative content analysis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112798 0
Ms Annabelle Vaughan
Address 112798 0
Gold Coast University Hospital
1 Hospital Blvd
Southport QLD 4215
Country 112798 0
Australia
Phone 112798 0
+61 756873431
Fax 112798 0
Email 112798 0
[email protected]
Contact person for public queries
Name 112799 0
Ms Annabelle Vaughan
Address 112799 0
Gold Coast University Hospital
1 Hospital Blvd
Southport QLD 4215
Country 112799 0
Australia
Phone 112799 0
+61 756873431
Fax 112799 0
Email 112799 0
[email protected]
Contact person for scientific queries
Name 112800 0
Ms Annabelle Vaughan
Address 112800 0
Gold Coast University Hospital
1 Hospital Blvd
Southport QLD 4215
Country 112800 0
Australia
Phone 112800 0
+61 756873431
Fax 112800 0
Email 112800 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All collected data will be de-identified prior to analysis. Only aggregated data will be used in the
reporting and dissemination of research findings. For qualitative data, representative participant
quotes will be labelled using de-identified participant numbers to ensure individuals are nonidentifiable; e.g. P01, P02 etc. All collected data will only be accessible to the research team
and assistants.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12610Study protocol  [email protected]



Results publications and other study-related documents

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