Enhancing Post-Stroke Dysphagia Rehabilitation Via the Synergistic Effects of Neuromuscular Electrical Stimulation, Neuromuscular Taping, and Swallowing Exercises: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Hamad Medical Corporation
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- surface Electromyography (sEMG)
Study Overview
Brief Summary
The goal of this clinical trial is to investigate the effects of a combined swallowing intervention (Neuromuscular Electrical Stimulation (NMES) + Neuromuscular Taping (NMT) + swallowing exercises) on swallowing function and quality of life in post-stroke dysphagia patients. The main questions it aims to answer are:
• Does the combination of swallowing exercises, NMES & NMT have a greater improvement in dysphagia rehabilitation when compared to either NMES or NMT alone? Researchers will compare the effects of intervention between the three groups (NMES and swallowing exercises, NMT and swallowing exercises, and NMES with NMT and swallowing exercises).
Participants will:
- Receive a combined dysphagia rehabilitation comprised of swallowing exercises, Neuromuscular Electrical stimulation, and/or Neuromuscular Taping.
- Visit the clinic once every 5 days a week for 10 therapy sessions.
- Undergo baseline and post-intervention evaluation procedures.
Detailed Description
This proposed study will be conducted using a prospective, three-group, randomized controlled trial. The participants for this study will be recruited from the post-acute and rehabilitation units who are diagnosed with post-stroke dysphagia at Hamad Medical Corporation hospitals in the State of Qatar.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
The outcomes assessor
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients aged 18 - 75 years old,
- •Diagnosed with swallowing disorders between one day and six months post-stroke,
- •Able to attend 10 therapy sessions,
- •Have never received any swallowing treatment before participating in this study.
Exclusion Criteria
- •Post-stroke patients with severe cognitive impairment,
- •Patients who have swallowing disorders due to other etiologies,
- •Patients who need traditional swallowing therapy other than Expiratory Muscle Strength Training (EMST) and Chin Tuck Against Resistance (CTAR). - Skin disorders in the submental area and anterior neck,
- •Medical conditions that may affect participation,
- •A defibrillator and use precision electrical biomedical devices (e.g. pacemaker, etc.).
Arms & Interventions
Group A
Participants will receive neuromuscular electrical stimulation + swallowing exercises ( chin tuck against resistance + expiratory muscle strength training)
Intervention: Neuromuscular Electrical Stimulation (Procedure)
Group A
Participants will receive neuromuscular electrical stimulation + swallowing exercises ( chin tuck against resistance + expiratory muscle strength training)
Intervention: Swallowing exercise (Expiratory Muscle Strength Training) (Procedure)
Group A
Participants will receive neuromuscular electrical stimulation + swallowing exercises ( chin tuck against resistance + expiratory muscle strength training)
Intervention: Swallowing exercise (Chin Tuck Against Resistance) (Procedure)
Group B
Participants will receive neuromuscular taping + swallowing exercises (chin tuck against resistance + expiratory muscle strength training)
Intervention: Neuromuscular Taping (Procedure)
Group B
Participants will receive neuromuscular taping + swallowing exercises (chin tuck against resistance + expiratory muscle strength training)
Intervention: Swallowing exercise (Expiratory Muscle Strength Training) (Procedure)
Group B
Participants will receive neuromuscular taping + swallowing exercises (chin tuck against resistance + expiratory muscle strength training)
Intervention: Swallowing exercise (Chin Tuck Against Resistance) (Procedure)
Group C
Participants will receive neuromuscular electrical stimulation + neuromuscular taping + swallowing exercises (chin tuck against resistance + expiratory muscle strength training)
Intervention: Swallowing exercise (Chin Tuck Against Resistance) (Procedure)
Group C
Participants will receive neuromuscular electrical stimulation + neuromuscular taping + swallowing exercises (chin tuck against resistance + expiratory muscle strength training)
Intervention: Neuromuscular Electrical Stimulation (Procedure)
Group C
Participants will receive neuromuscular electrical stimulation + neuromuscular taping + swallowing exercises (chin tuck against resistance + expiratory muscle strength training)
Intervention: Neuromuscular Taping (Procedure)
Group C
Participants will receive neuromuscular electrical stimulation + neuromuscular taping + swallowing exercises (chin tuck against resistance + expiratory muscle strength training)
Intervention: Swallowing exercise (Expiratory Muscle Strength Training) (Procedure)
Outcomes
Primary Outcomes
surface Electromyography (sEMG)
Time Frame: Pre-intervention: "Baseline" or "Day 1". Post-intervention: immediately after the intervention, up to 15 days of start the intervention.
Surface EMG biofeedback is typically implemented by placing surface electrodes over a patient's under-chin area or submental muscles to observe the changes in muscle actions during swallowing. The recorded signals are processed and converted into a visual demonstration or auditory prompt. The participants' swallowing muscles (suprahyoid) performance will be measured using the maximum work parameter to compare each participant's performance per- and post- intervention.
Penetration-Aspiration Scale (PAS) score
Time Frame: Pre-intervention: "Baseline" or "Day 1". Post-intervention: immediately after the intervention, up to 15 days of start the intervention.
It is an 8-point ordinal scale, with 1 representing the least and 8 representing the highest or most severe score. PAS scores are multidimensional, i.e., include several observations within each score: (1) depth of airway invasion (material above, contacting, or below the level of vocal folds; (2) whether or not there is material remaining after the swallow (ejected, not ejected); and (3) the patient's response to material present in the airway (effort to clear the material)
Dysphagia Handicap Index
Time Frame: Pre-intervention: "Baseline" or "Day 1". Post-intervention: immediately after the intervention, up to 15 days of start the intervention.
Dysphagia Handicap Index is comprised of a 25-item self-administered questionnaire. It is an instrument for measuring the handicapping impact of swallowing disorder on the physical, functional, and emotional facets of individuals' lives. Respondents replied never, sometimes, or always to each statement and rated their self-perceived dysphagia severity on a 7-point equal-appearing interval scale. 1 indicates normal swallowing and 7 indicates server swallowing problem.
Secondary Outcomes
- DYSPHAGIA OUTCOME SEVERITY SCALE (DOSS)(Pre-intervention: "Baseline" or "Day 1". Post-intervention: immediately after the intervention, up to 15 days of start the intervention.)
- Hyoid bone displacement(Pre-intervention: "Baseline" or "Day 1". Post-intervention: immediately after the intervention, up to 15 days of start the intervention.)
Investigators
Ibrahim Mohammed Abdul Fattah Al Ayaseh
Speech-Language Pathology Supervisor
Hamad Medical Corporation