REhabilitation of Dysphagia with ACupuncture and AuriculoTherapy in Non-communicative Patients with Severe Acquired Brain Injury (REDACT-Study): a Pilot Controlled Randomized Double Blinded Trial Study Protocol
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Significant difference measured by Mann Assessment of Swallowing Ability (MASA) Scale
Study Overview
Brief Summary
The goal of this interventional, randomized, controlled, double-blind pilot study is to assess the superiority of Acupuncture and Auriculotherapy, in addition to conventional speech therapy rehabilitation, for the treatment of dysphagia in patients with severe Acquired Brain Injury (sABI) of vascular etiology, who are tracheostomized and have severe cognitive impairment, classified as Level of Cognitive Functioning (LCF) <4 according to the LCF Scale.
The main questions this study aims to answer are:
- Does a treatment of 10 sessions of Acupuncture and Auriculotherapy, in addition to conventional speech therapy rehabilitation, help reduce dysphagia, as measured by clinical and instrumental scales, and shorten the time to decannulation after 4 weeks of treatment?
- Is the obtained result maintained 3 months after the end of the rehabilitation treatment?
Researchers will compare patients receiving conventional speech therapy rehabilitation with those also undergoing 10 sessions of Acupuncture and Auriculotherapy to determine whether this ancient Chinese technique can improve dysphagia and reduce time to decannulation in patients with vascular sABI and severe cognitive impairment.
Participants will be assigned to either the Intervention Group (Acupuncture and Auriculotherapy in addition to conventional rehabilitation) or the Control Group (conventional rehabilitation only). In both groups, conventional speech therapy rehabilitation will consist of 1 hour of treatment per day. The Intervention Group will undergo additional rehabilitation treatment using specific acupuncture and auriculotherapy points.
Detailed Description
On admission to the Intensive Rehabilitation Unit (IRU), patients with severe Acquired Brain Injury (sABI) often present with severe dysphagia (incidence up to 93%) and require a tracheal cannula (50-70%). During this intensive rehabilitation phase, the restoration of oral feeding and decannulation are two crucial and closely linked objectives. Studies have shown that the inability to manage saliva and dysphagia represents the main obstacle to decannulation, even in the long term.
Due to the extreme heterogeneity of patients with sABI and the lack of guidelines and consensus on the modalities and timing of dysphagia rehabilitation, swallowing rehabilitation still lacks standardization. Furthermore, most dysphagia rehabilitation techniques (both compensatory and restorative) require a certain degree of active patient collaboration, making them difficult to apply in sub-acute sABI patients.
In this context, acupuncture, which is already recommended by various international guidelines for conditions such as spasticity and pain, could be a valid therapeutic option. In fact, this technique has shown potential in reducing sialorrhea and muscular contractures in the oro-facial area, even in non-cooperative patients, such as those with a Disorder of Consciousness (DoC) or cognitive impairment.
This study aims to verify the effectiveness of Acupuncture and Auriculotherapy in the rehabilitation of dysphagia and tracheal cannula weaning in non-cooperative patients with sABI outcomes. The goal is to support the use of a safe, low-cost, bedside technique with no side effects, potentially applicable in all settings and during all rehabilitation phases.
The study will enroll 24 patients admitted to the IRU of the IRCCS-Fondazione Don Gnocchi of Florence for sABI of vascular etiology.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of severe Acquired Brain Injury with vascular etiology (ischemic or hemorrhagic), confirmed by Computerized Tomography or Magnetic Resonance Imaging.
- •Time between acute event and enrollment: 1 to 3 months. Age >18 years. Presence of a tracheal cannula upon admission to the Intensive Rehabilitation Unit.
- •Level of Cognitive Functioning (LCF) < or =
- •Informed consent signed by the patient's legal representative.
Exclusion Criteria
- •Instability of general clinical conditions, including mechanical ventilation, sedation, sepsis or sub-emergent epileptic seizures.
- •Patients in Unresponsive Wakefulness Syndrome (UWS), according to the Coma Recovery Scale-Revised (CRS-R).
- •Known agoraphobia.
Arms & Interventions
Acupuncture and Auriculotherapy
Patients assigned to the intervention arm will receive conventional speech therapy rehabilitation (as in the control group) along with 2 or 3 weekly sessions of Acupuncture and Auriculotherapy, each lasting 20 minutes. The treatment will follow a protocol developed in collaboration with experienced acupuncture physicians and will involve the placement of approximately 10 somatic and auricular needles.
Intervention: Acupuncture and Auricolotherapy (Other)
Acupuncture and Auriculotherapy
Patients assigned to the intervention arm will receive conventional speech therapy rehabilitation (as in the control group) along with 2 or 3 weekly sessions of Acupuncture and Auriculotherapy, each lasting 20 minutes. The treatment will follow a protocol developed in collaboration with experienced acupuncture physicians and will involve the placement of approximately 10 somatic and auricular needles.
Intervention: Conventional logopedic rehabilitation (Other)
Conventional speech therapy rehabilitation
Patients assigned to the control arm will undergo conventional speech therapy rehabilitation, which involves one hour per day of treatment, including restorative or passive compensatory interventions (e.g., modifications in food consistency and posture, passive exercises to improve swallowing structures) and the standard protocol for tracheal cannula weaning.
Intervention: Conventional logopedic rehabilitation (Other)
Outcomes
Primary Outcomes
Significant difference measured by Mann Assessment of Swallowing Ability (MASA) Scale
Time Frame: From enrollment to the end of treatment at 4 weeks and at 3 months
The Mann Assessment of Swallowing Ability (MASA) Scale consists of 26 items. The sum of the individual scores provides a total score that categorizes dysphagia and aspiration into four levels of severity. Dysphagia severity: The highest possible score is 200. 200-178: No abnormality detected 177-168: Mild dysphagia 167-139: Moderate dysphagia Below 138: Severe dysphagia (worst possible grade) Aspiration severity: The highest possible score is 200. 200-170: No abnormality detected 169-149: Mild aspiration 148-140: Moderate aspiration Below 140: Severe aspiration (worst possible grade)
Significant difference measured by Pooling Score, based on endoscopic landmarks and bedside parameters with relative values
Time Frame: From enrollment to the end of treatment at 4 weeks and at 3 months
The Pooling Score is a clinical endoscopic evaluation used to assess the severity of swallowing disorders, considering excess residue in the pharynx and larynx. The score ranges from a minimum of 4 to a maximum of 11 and is calculated by summing the scores assigned to: Bolus location Amount of residue Ability to control residue/bolus pooling, assessed based on coughing, throat clearing (raclage), and the number of dry voluntary or reflex swallowing attempts (\<2, 2-5, \>5).
Secondary Outcomes
No secondary outcomes reported