NCT05859438

Brief 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. 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. 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 16, 2023

Completed
15 days until next milestone

Study Start

First participant enrolled

May 31, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

March 30, 2025

Status Verified

December 1, 2024

Enrollment Period

1.8 years

First QC Date

April 20, 2023

Last Update Submit

March 25, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Goal Attainment Scale (measuring change between time points of distance from goal)

    Measures attainment of participant defined goals.

    Baseline, 3 and 6 months

Secondary Outcomes (1)

  • Pragmatic Profile of Everyday Communication Skills in Adults (measuring change between time points of pragmatic communication)

    Baseline, 3 and 6 months.

Other Outcomes (6)

  • Speed of Communication by measuring time taken to speak out phrase with device - measuring change between timepoints.

    3 and 6 months

  • System Usability Scale (measuring change between time points)

    3 and 6 months

  • Semi-structured interview

    Baseline

  • +3 more other outcomes

Study Arms (1)

Intervention group

EXPERIMENTAL
Other: Communication aid support

Interventions

Support to use voice input voice output communication aids

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barnsley Hospital NHS Foundation Trust

Barnsley, S75 2EP, United Kingdom

Location

MeSH Terms

Conditions

Dysarthria

Condition Hierarchy (Ancestors)

Articulation DisordersSpeech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kate Fryer

    University of Sheffield

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2023

First Posted

May 16, 2023

Study Start

May 31, 2023

Primary Completion

March 1, 2025

Study Completion

April 1, 2025

Last Updated

March 30, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations