Trial Outcomes & Findings for An RCT of a Telemedicine Intervention for Hypokinetic Dysarthria in PD (NCT NCT04617496)

Results Overview

Speech intelligibility is the degree to which spoken language can be understood by a listener. It is measured by the percentage of words that are understood from a recording of a participant reading a random set of 11 sentences from the Assessment of Intelligibility in Dysarthric Speech Sentence Intelligibility Test stimulus bank. Native speakers of American English listened to these recordings to assess speech intelligibility. These listeners were between the ages of 18 and 35 with no history of speech, language, or hearing disorders or experience rating speech. Each listener was provided with one sentence from each study participant's recording. Listeners were asked to transcribe each sentence to the best of their ability. Their transcriptions were compared with the actual sentences to calculate the percentage of words that were understood. Possible scores range from 0 (no words understood) to 100 (all words understood). Change = (6-month score - Baseline score)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

104 participants

Primary outcome timeframe

Baseline and 6-month Follow-up

Results posted on

2026-01-07

Participant Flow

Participant milestones

Participant milestones
Measure	Combined Speech and Exercise Intervention Home-based exercise intervention with interactive automated speech response features that encourage a higher level of speech performance. Combined speech and exercise intervention: Home-based exercise intervention with interactive automated speech response features	Control Group Health education Health education: Provision of general information about a variety of topics
Overall Study STARTED	50	54
Overall Study COMPLETED	45	50
Overall Study NOT COMPLETED	5	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Combined Speech and Exercise Intervention Home-based exercise intervention with interactive automated speech response features that encourage a higher level of speech performance. Combined speech and exercise intervention: Home-based exercise intervention with interactive automated speech response features	Control Group Health education Health education: Provision of general information about a variety of topics
Overall Study Death	2	1
Overall Study Lost to Follow-up	3	3

Baseline Characteristics

An RCT of a Telemedicine Intervention for Hypokinetic Dysarthria in PD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Combined Speech and Exercise Intervention n=50 Participants Home-based exercise intervention with interactive automated speech response features that encourage a higher level of speech performance. Combined speech and exercise intervention: Home-based exercise intervention with interactive automated speech response features	Control Group n=54 Participants Health education Health education: Provision of general information about a variety of topics	Total n=104 Participants Total of all reporting groups
Age, Continuous	76.5 years STANDARD_DEVIATION 5.5 • n=37 Participants	73.5 years STANDARD_DEVIATION 6.5 • n=56 Participants	74.9 years STANDARD_DEVIATION 6.2 • n=95 Participants
Sex: Female, Male Female	0 Participants n=37 Participants	0 Participants n=56 Participants	0 Participants n=95 Participants
Sex: Female, Male Male	50 Participants n=37 Participants	54 Participants n=56 Participants	104 Participants n=95 Participants
Race/Ethnicity, Customized Race/Ethnicity · White, Non-Hispanic	50 Participants n=37 Participants	53 Participants n=56 Participants	103 Participants n=95 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black	0 Participants n=37 Participants	1 Participants n=56 Participants	1 Participants n=95 Participants
Speech Intelligibility	48.7 units on a scale STANDARD_DEVIATION 23.0 • n=37 Participants	46.5 units on a scale STANDARD_DEVIATION 18.4 • n=56 Participants	47.7 units on a scale STANDARD_DEVIATION 20.8 • n=95 Participants
Communication Effectiveness Score	50.6 units on a scale STANDARD_DEVIATION 18.2 • n=37 Participants	57.5 units on a scale STANDARD_DEVIATION 14.1 • n=56 Participants	54.2 units on a scale STANDARD_DEVIATION 16.5 • n=95 Participants

PRIMARY outcome

Timeframe: Baseline and 6-month Follow-up

Speech intelligibility is the degree to which spoken language can be understood by a listener. It is measured by the percentage of words that are understood from a recording of a participant reading a random set of 11 sentences from the Assessment of Intelligibility in Dysarthric Speech Sentence Intelligibility Test stimulus bank. Native speakers of American English listened to these recordings to assess speech intelligibility. These listeners were between the ages of 18 and 35 with no history of speech, language, or hearing disorders or experience rating speech. Each listener was provided with one sentence from each study participant's recording. Listeners were asked to transcribe each sentence to the best of their ability. Their transcriptions were compared with the actual sentences to calculate the percentage of words that were understood. Possible scores range from 0 (no words understood) to 100 (all words understood). Change = (6-month score - Baseline score)

Outcome measures

Outcome measures
Measure	Combined Speech and Exercise Intervention n=40 Participants Home-based exercise intervention with interactive automated speech response features that encourage a higher level of speech performance. Combined speech and exercise intervention: Home-based exercise intervention with interactive automated speech response features	Control Group n=37 Participants Health education Health education: Provision of general information about a variety of topics
Change in Speech Intelligibility at 6 Months	0.25 score on a scale Interval -23.5 to 28.6	-4.78 score on a scale Interval -45.9 to 24.4

SECONDARY outcome

Timeframe: Baseline and 6-month Follow-up

CETI-M is a self-reported instrument assessing participants' communicative effectiveness in 10 different speaking situations (e.g., in noisy environments; over the phone) on a 10-point Likert scale, where 1 = not effective and 10 = extremely effective. Possible scores range from 10 (worst rated effectiveness) to 100 (best rated effectiveness). Change = (6-month score - Baseline score)

Outcome measures

Outcome measures
Measure	Combined Speech and Exercise Intervention n=45 Participants Home-based exercise intervention with interactive automated speech response features that encourage a higher level of speech performance. Combined speech and exercise intervention: Home-based exercise intervention with interactive automated speech response features	Control Group n=50 Participants Health education Health education: Provision of general information about a variety of topics
Change in in Self-perceived Communication Ability Measured Via the Communication Effectiveness Index (CETI-M) at 6 Months	6.8 score on a scale Interval -33.1 to 57.0	-6.4 score on a scale Interval -55.0 to 32.0

Adverse Events

Combined Speech and Exercise Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. David Sparrow

VA Boston Healthcare System

Phone: 857-364-6407

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place