Fine Motor Skills and Post-Stroke Swallowing

NCT05224973 | Active Not Recruiting

• 1 other identifier: 21-PP-14
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Swallowing disorders are a common consequence of stroke. After stroke, some patients retain a dysphagia responsible for an alteration of the quality of life, respiratory diseases and a degradation of the general health status. The oral phase of the swallowing involves a significant control of the various intraoral organs. These allow the formation of the bolus, its propulsion, and the emptying of the oral cavity after swallowing. Precise and coordinated mobility of the tongue, lips and mandible is essential during this time. During the speech therapy after a stroke, targeted analytical training, coupled with passive stimulations of the swallowing reflex, is typically used. Previous studies have shown a functional link between fine manual motor skills and oral motor skills, particularly during child development. Little data are available for adult subjects. A pilot study is therefore needed before a larger scale comparative study can be considered. Our hypothesis is that there is a functional link between digital and oral motor areas that could, through co-activation during rehabilitation sessions, promote the recovery of swallowing disorders after stroke.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• change of score on the lingual myofunctional analytical evaluation scale

  at day 0 and at day 60

Secondary Outcomes (5)

• score of the analytical swallowing scale

  at day 0 and at day 60

• score on the functional swallowing scale

  at day 0 and at day 60

• Pressure in kg between c1) tongue and palate (J60) ; c2) lips (J60), c3) mandibles

  at day 0 and at day 60

• likert acceptance scale

  at day 60

• proportion of patients who were able to complete the entire rehabilitation program

  at day 60

Study Arms (2)

speech therapy combined with digital fine motor stimulation

EXPERIMENTAL

At the beginning of the swallowing rehabilitation session, a fine manual motor training is practiced during the first ten minutes of the session. Training consists of activities requiring increasing precision and different types of grips

Behavioral: speech therapy

speech therapy only

ACTIVE COMPARATOR

standard swallowing rehabilitation session

Behavioral: speech therapy

Interventions

speech therapy BEHAVIORAL

speech therapy during 2 months

speech therapy combined with digital fine motor stimulation; speech therapy only

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age \> 70 years
• stroke \< 20 days
• Clinical signs of dysphagia
• Patient affiliated or beneficiary of a social security scheme
• Signing of free and informed consent

You may not qualify if:

• Patients with known anterior dysphagia
• Inability to understand rehabilitation instructions and/or actively participate in the rehabilitation process

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, 06000, France

Location

MeSH Terms

Conditions

Stroke

Interventions

Speech Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language Disorders; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Guillaume SACCO, MD

  gerontology department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: February 4, 2022
• Study Start: November 23, 2022
• Primary Completion: May 23, 2025
• Study Completion (Estimated): June 6, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)