Neuromuscular Electrical Stimulation (NMES) Treatment Technique Therapy in the Management of Young Infants With Severe Dysphagia
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|ClinicalTrials.gov Identifier: NCT01723358|
Recruitment Status : Completed
First Posted : November 7, 2012
Last Update Posted : July 20, 2015
|Condition or disease||Intervention/treatment||Phase|
|Dysphagia||Device: Neuromuscular electrical stimulation (NMES)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effectiveness of a New Neuromuscular Electrical Stimulation (NMES) Treatment Technique (VitalStim® Therapy) in the Management of Young Infants With Severe Dysphagia: a Prospective Pilot Study|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||July 2012|
|Experimental: Neuromuscular electrical stimulation (NMES)||
Device: Neuromuscular electrical stimulation (NMES)
The intervention will consist of a period of treatment with NMES. This treatment will involve 20-45 minute feeding therapy sessions during which NMES will be administered by an Occupational Therapist. Frequency of therapy sessions will be 4 times per week for the first 2 weeks (as in inpatient, if hospitalized) and then biweekly for 14 weeks for a total of 36 sessions (over 16 weeks). For patients who are discharged prior to the first 2 weeks of treatment, outpatient sessions will be biweekly.
Other Name: VitalStim® therapy
- Effectiveness [ Time Frame: 4 months ]The primary outcome will be an improvement in swallowing function as determined by videofluoroscopic feeding study from baseline to end of treatment (4 months after baseline). The swallowing function will be graded as to the number of textures the infant can safely swallow at three measurement points (baseline, 2 months and 4 months). An improvement in the number of textures the infant can swallow will define improvement. This will be recorded using a standard reporting form.
- Resolution of dysphagia [ Time Frame: 4 months ]The proportion of children whose dysphagia resolves (i.e. safe to feed on all consistencies of solids and liquids) at 4 months will be calculated.
- Feeding ability [ Time Frame: baseline, 2 months and 4 months from enrollment ]The feeding ability will be assessed using a clinical exam by an occupational therapist.
- Oral feeding ability and need for tube feeding [ Time Frame: baseline, 2 months, 4 months from enrollment ]Oral feeding ability and the need for tube feeding will be assessed using a structured scale based on parental report of dietary intake that includes: Level 1: Nothing by mouth, all nutrition by tube feeds, Level 2: <50% intake by mouth, tube feeding requirement, Level 3: >50% intake by mouth, tube feeding, requirement, Level 4: All by mouth, no tube feeding.
- Hospitalizations for lower respiratory tract illness [ Time Frame: 4 months ]The frequency of hospitalizations for lower respiratory tract illnesses in the 4 months following enrollment into the study will be determined by administering a structured questionnaire to parents.
- Safety and Adverse events [ Time Frame: duration of subjects involvment in the study ]Data collection of adverse events will occur through administration of a structured questionnaire by the occupational therapist at the end of each treatment session and just prior to the subsequent session.
- Caregiver acceptability and perception of feeding [ Time Frame: at 4 months ]Two questions using a 10 cm visual analogue scale will ask whether parents were satisfied with the treatment process and whether the caregiver felt that their child's feeding ability improved during treatment. Two further open ended questions will probe what aspects of the treatment they felt were positive and what aspects they felt were negative.
- Data on treatment procedures [ Time Frame: 4 months ]Data will be collected by the occupational therapist after each treatment session. This will include method of feeding, amount of food taken, response to treatment, length of treatment session, location of electrode placement and amplitude of stimulation used.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01723358
|The Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G 1X8|
|Principal Investigator:||Sanjay Mahant, MD||The Hospital for Sick Children, Toronto Canada|