An investigation into the feasibility of implementing facial taping for adults with central facial palsy via a combined telehealth model: a nonrandomized control trial.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12621001262897

Enrollment

Registered

2021-09-17

Start date

2021-10-01

Completion date

2023-10-31

Last updated

2021-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Non-randomised trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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.

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.

Outcome results