INcorporating VoIce acTivated Communication Aids Into Everyday Communication

Dysarthria Clinical Trial

— INVITE  

Official title:

INcorporating VoIce acTivated Communication Aids Into Everyday Communication

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05859438
• Other study ID #: 171440
• Status: Recruiting
• Phase: N/A
• Start date: May 2023
• Est. completion date: July 2024

Study information

• Verified date: April 2023
• Source: University of Sheffield
• Contact: Kate Fryer, PhD
• Phone: 07726597377
• Email: k.fryer[@]sheffield.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Dysarthria is a speech disorder resulting in speech that is slow, slurred and difficult to understand, limiting a person's opportunities to study, work, and develop relationships.

People with dysarthria often use communication aids to help them to communicate creating spoken messages using a keyboard, touchscreen or joystick. Communication aids can increase independence but are often too slow to keep pace with normal conversation.

Developments in speech recognition technology have led to apps which can learn to recognise a set of words or sounds spoken by the individual with dysarthria, and connect these with a clear spoken output. The investigator's previous research provides some evidence that these voice input communication apps may be faster than traditional communication aids. This study aims to find out who can benefit from this technology, and what support they will need to use it successfully. This information can be used by professionals involved in providing communication aids, and will help the investigators to plan further research into their effectiveness.

This research has two phases:

1. 20-30 individuals with dysarthria will be asked to use a voice input communication app for 6 months. The investigator's will collect information on whether VocaTempo improves their communication, and helps participants to reach their goals.

2. Focus groups will be held with professionals involved in providing and supporting people with communication aids, to understand factors affecting their ability to provide the support identified as needed in part 1 of the research.

The investigators have a panel of communication aid users, who are advising and contributing throughout the study, for example, helping the investigators to identify informal support networks to recruit participants from. The investigators will let people know about the findings through support groups used by people with dysarthria, publications read by people involved in providing communication aids, and academic papers and conferences.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Over 18 years of age

• Moderately or severely dysarthric (identified using the Frenchay Dysarthria assessment

• Minimum of 2 distinct vocalisations over which they have voluntary control

• Able to give informed consent and take part in interviews with appropriate communication support (scores level 1-3 on consent support tool)

• Communicates predominantly in English

Exclusion Criteria:

• They have significant cognitive impairment and are unable to give informed consent on their own behalf or actively take part in interviews (tested using the Consent Support Tool, scoring at level 4), or are unable to use a communication aid.

• They have no controlled vocalisations.

• They have dysarthria as a result of a progressive condition

Related Conditions & MeSH terms

• Dysarthria

Intervention

Other:
• Communication aid support
Support to use voice input voice output communication aids

Locations

Country	Name	City	State
United Kingdom	Barnsley Hospital NHS Foundation Trust	Barnsley

Sponsors (2)

Lead Sponsor	Collaborator
University of Sheffield	Barnsley Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Speed of Communication by measuring time taken to speak out phrase with device - measuring change between timepoints.	Measuring speed of communicating with communication aid	3 and 6 months
Other	System Usability Scale (measuring change between time points)	Questionnaire asking about usability of communication aid	3 and 6 months
Other	Semi-structured interview	Conversation to ascertain participants experience	Baseline
Other	Semi-structured interview	Conversation to ascertain participants experience	3 months
Other	Semi-structured interview	Conversation to ascertain participants experience	6 months
Other	Participant diary (emails between participant and research which will be used as qualitative data).	Email diary	6 months
Primary	Goal Attainment Scale (measuring change between time points of distance from goal)	Measures attainment of participant defined goals.	Baseline, 3 and 6 months
Secondary	Pragmatic Profile of Everyday Communication Skills in Adults (measuring change between time points of pragmatic communication)	Assesses pragmatic language use	Baseline, 3 and 6 months.