The aim is to demonstrate the effectiveness of personalized and home-based speech therapy on quality of life, intelligibility and social participation for people with Parkinson*s disease who have a reduced intelligibility of speech.
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is the quality of life, measured in the total score
on the PDQ-39.
Secondary outcome
The secondary outcomes will include:
- speech and voice quality (as assessed objectively with the Radboud Dysarthria
Assessment and the Acoustic Voice Quality Index, and subjectively with the
Voice Handicap Index)
- subjective severity of voice and speech complaints (Radboud Oral Motor
inventory for Parkinson's disease)
- subjective severity of voice and speech complaints by caregiver (adapted
Radboud Oral Motor inventory for Parkinson's disease)
- intelligibility (Dutch intelligibility test)
- caregiver burden (Zarit caregiver Burden Interview Short Form)
- mood and anxiety (Hospital Anxiety and Depression Scale)
- generic quality of life (EuroQol-5d)
- swallowing rate (ml/s)
- treatment report that speech therapists will fill out after treatment has
been completed
Background summary
Speech therapy addresses reduced speech quality and diminished intelligibility,
which occur in up to 70% of PD patients. This can have a profound negative
impact on social interaction and quality of life. Currently, there is level II
evidence to support existing speech therapy programs. The most recent Cochrane
reviews on this subject showed that evidence is growing for the existing
treatment programs, but is still inconclusive due to small sample sizes,
inadequate methodology, lack of outcomes relevant to PD patients, and
insufficient follow-up to determine the duration of any improvement. The
current research will be the first large-scale study to demonstrate the
efficacy of speech therapy in PD in quality of life and speech.
Study objective
The aim is to demonstrate the effectiveness of personalized and home-based
speech therapy on quality of life, intelligibility and social participation for
people with Parkinson*s disease who have a reduced intelligibility of speech.
Study design
We will perform a single blind, randomized and controlled trial (RCT),
comparing the speech therapy to no intervention (waiting list design).
Intervention
The patients will be randomly allocated to either the experimental group or the
control group (1:1 ratio). The experimental group will receive speech therapy
using tele-rehabilitation for 8 weeks which consists of 12-16 sessions. The
control group will be on a waiting list for 8 weeks.
Study burden and risks
The intervention evaluated in this study is noninvasive and safe, even for
patients with PD. The risks are very low, if not negligible. Both the
intervention and the assessments are home-based, so there will be no travel
burden. Participants are assessed two or three times, dependent on whether they
are in the experimental or the control group. This will take up to 2.5 hours at
a time.
Reinier Postlaan 4
Nijmegen 6500HB
NL
Reinier Postlaan 4
Nijmegen 6500HB
NL
Listed location countries
Age
Inclusion criteria
- problems in intelligibility affecting daily communication
- a desire for improvement
- willing and able to receive online treatment (PC or tablet with webcam and access to internet)
- 18 years or older
Exclusion criteria
- recent (<1 year) speech therapy
- voice or speech problems due to other causes
- communication difficulties based on language problems without predominantly reduced intelligibility
- inability to receive online treatment
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL67867.091.18 |