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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05859438
Other study ID # 171440
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
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