Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT05935618
Status:
RECRUITING
Last Update Posted:
2025-03-14
First Post:
2023-06-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Occupational Therapy Rehabilitation for Frail Elders with Dysphagia
Sponsor:
Hvidovre University Hospital
Organization:
Study Overview
Official Title:
No Food or Drink Does Any Good Until It is Swallowed: a Proof-of-concept Study on Occupational Therapy Rehabilitation for Frail Elders with Dysphagia
Status:
RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this proof-of-concept study is to assess the potential of a newly developed intervention with combined skill- and strength-based principles for maximizing swallowing-related outcomes and prevent further weakening of the swallowing muscles in older people with dysphagia (difficulty swallowing).
The main questions to be answered are:
1. Does the intervention produce clinically significant improvement in ingestive skills during meals in older individuals with dysphagia?
2. Does the intervention produce clinically significant improvements in tongue strength and orofacial function in older persons with dysphagia?
3. Does the intervention produce clinically significant improvements in nutritional status and quality of life in older individuals with dysphagia?
4. Is there an association between perceived autonomy support and intervention engagement when older individuals with dysphagia receive the intervention during hospitalization and continued in community-based rehabilitation after discharge?
Participants will be asked to perform goal-directed and task-specific swallowing exercises in eating and drinking activities where the intensity variables include advancing steps of an altered bolus volume and consistency according to a 17-level task hierarchy, which are introduced according to predetermined progression rules, as well as increases in swallowing repetitions. The dosage is 2-3 individual, face-to-face therapy sessions per week for up to a maximum of eight weeks. A therapy session lasts up to 45 min. In between therapy sessions, participants integrate the achieved level from therapy into their daily meals as self-training.
The main questions to be answered are:
1. Does the intervention produce clinically significant improvement in ingestive skills during meals in older individuals with dysphagia?
2. Does the intervention produce clinically significant improvements in tongue strength and orofacial function in older persons with dysphagia?
3. Does the intervention produce clinically significant improvements in nutritional status and quality of life in older individuals with dysphagia?
4. Is there an association between perceived autonomy support and intervention engagement when older individuals with dysphagia receive the intervention during hospitalization and continued in community-based rehabilitation after discharge?
Participants will be asked to perform goal-directed and task-specific swallowing exercises in eating and drinking activities where the intensity variables include advancing steps of an altered bolus volume and consistency according to a 17-level task hierarchy, which are introduced according to predetermined progression rules, as well as increases in swallowing repetitions. The dosage is 2-3 individual, face-to-face therapy sessions per week for up to a maximum of eight weeks. A therapy session lasts up to 45 min. In between therapy sessions, participants integrate the achieved level from therapy into their daily meals as self-training.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: