An inconspicuous, non-invasive, mobile sensor device for real-time control of assistive technologies through facial expressio

Not Applicable

Completed

• Conditions: Parkinson's disease, facial palsy; Nervous System Diseases; Parkinson's disease

• Registration Number: ISRCTN21782066
• Lead Sponsor: Queen Victoria Hospital NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-20
• Study Completion: 2020-09-30
• Last Update Posted: 19 September 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

All participants:
1. Aged 18-75 years
2. ASA I (normal, healthy) or II (mild systemic disease, no functional limitation, e.g. smoker with well-controlled hypertension)
3. Ability to read and understand English
4. Use of both hands
5. Ambulatory (able to walk around own home (walking aids are allowed))

Additional inclusion criteria for participants with facial palsy:
1. Unilateral facial palsy (i.e. one side effected)
2. A facial grading score, using the House-Brackmann scale, of less than 6
3. A facial grading score, using the Sunnybrook Facial Grading System, of less than 100

Additional inclusion criteria for participants with Parkinson's disease:
1. Clinical diagnosis of Parkinson’s disease
2. Stable medication for at least 6 weeks

Exclusion Criteria

All participants:
1. Evidence of neuro-muscular dysfunction

Additional exclusion criteria for participants with facial palsy:
1. History of facial surgery (except eye lid surgery)

Additional exclusion criteria for participants with Parkinson's disease:
1. Unable to walk

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The range of facial expressions in response to emotional stimuli, as measured by facial muscle activity by EMG and FRAME sensors in a single visit

Secondary Outcome Measures

Name	Time	Method
<br> Measured at baseline, upon study completion, and at three-daily intervals, prompted by automated calls to their smartphone, for each day the participants are wearing FRAME:<br> 1. Personality, assessed using OCEAN<br> 2. Presence of any existing mental health issues, assessed using CORE-10. Participants who reveal potential mental health issues will be advised that we will write to their GP informing them of the results of the questionnaire<br> 3. Quality of life, assessed using SF36<br> 4. Current mood at time of assessment, assessed using Self-Assessment Mannikin (SAM)<br> 5. Disease-specific issues, assessed using UPDRS & SAQ<br>