Impact of Wearable Biofeedback for the Rehabilitation and Tele-rehabilitation of Neurogenic Dysphagia
概览
- 阶段
- 2 期
- 干预措施
- In-person sEMG-biofeedback
- 疾病 / 适应症
- Dysphagia
- 发起方
- Purdue University
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Penetration-Aspiration Scale (PAS)
- 状态
- 招募中
- 最后更新
- 3个月前
概览
简要总结
Dysphagia, or difficulty swallowing, is a common symptom of many neurological diseases but its treatment is not well established or easily accessible.
To start addressing this gap, the researchers developed and validated a cost-effective wearable surface electromyography (sEMG) biofeedback sensor technology (i-Phagia), optimized to record muscle activity from the head/neck and provide biofeedback to patients and adherence data to clinicians during swallow therapy. This system has been developed with commercially available and widely used materials and the Purdue University IRB has determined that the device is non-significant risk device.
The goal of this clinical trial is to learn if this biofeedback (using this new technology/i-Phagia) when used as an adjunct to a standard swallow therapy protocol works to improve swallowing function in patients post chronic stroke or diagnosed with Parkinson's disease. It will also help the investigators learn whether this therapy protocol is equally effective when provided in-person versus via telehealth. Finally, it will determine which patient factors may influence how well the treatment works.
The main questions it aims to answer are:
- Does biofeedback (using this new technology/i-Phagia) when used as an adjunct to a standard swallow therapy protocol works better than a standard of care treatment to improve swallowing function in patients post chronic stroke or diagnosed with Parkinson's disease?
- Is completing the swallow therapy protocol at home (via telehealth) as effective as completing it in-person (in the clinic)?
- What factors related to the patients (e.g., age, diagnosis, etc.) may influence how well the treatment works?
Participants will:
- Complete a 12-week swallow treatment protocol (12 treatment visits) either in-person or at home (via telehealth)
- Complete 3 in-person evaluations (pre-treatment; post-treatment; and at a 12-week post treatment follow-up time point)
- Exercise at home several days per week and keep a diary/log of their home exercise
The hypothesis is that upon study completion, the efficacy of sEMG biofeedback-facilitated swallow therapy for both in-person and telehealth service delivery in two neurogenic dysphagia populations will have been established, and variables determining response to treatment will begin to be identified.
研究者
入排标准
入选标准
- •50-90 years old
- •a confirmed (by a neurologist/physician) diagnosis of stroke at least 3 months post event, or of PD (Hoehn and Yahr Stages II-IV)
- •score in the normal/mild range on the Montreal Cognitive Assessment (MoCA), determined during an in-house screening
- •confirmed oropharyngeal dysphagia, as evaluated during the intervention eligibility assessment by a certified and trained Speech Language Pathologist (SLP)
- •accuracy of exercise performance; as evaluated during the intervention eligibility assessment by a certified and trained SLP
- •independent (or with caregiver support) use of i-Phagia system post pre-intervention training session; as evaluated during the intervention eligibility assessment by a certified and trained SLP
排除标准
- •known allergy to barium or known/suspected perforation or obstruction of the gastrointestinal (GI) tract
- •recent history of pneumonia (past 6 months)
- •head and neck surgery, radiation or trauma
- •a score in the moderate-severe range on MoCA (screened during in-house screening)
- •other neurological/neuromuscular disorders (e.g., multiple sclerosis, brain tumor, myositis, etc)
- •difficulty complying due to neuropsychological dysfunction determined during the in-house screening
- •currently enrolled in swallow or speech therapy
- •facial hair in the submental (under the chin) area and refusing to shave.
- •known allergies relating to the Ten20® Conductive Paste (this is the conductive paste used to help with sensors signal and adherence to the skin) and/or any of the sensor materials (gold/acrylic) that come into contact with the skin
- •no oropharyngeal dysphagia; as evaluated during the intervention eligibility assessment by the certified and trained SLP
研究组 & 干预措施
IN-person i-Phagia
The treatment group assigned to the IN-PERSON i-Phagia service delivery will use the system to complete a standardized swallowing rehabilitation protocol for 12 weeks with weekly (once per week) treatment sessions in the clinic and 3 days of home practice per week.
干预措施: In-person sEMG-biofeedback
Remote i-Phagia
The treatment group assigned to the REMOTE i-Phagia service delivery will use the i-Phagia system to complete a standardized swallowing rehabilitation protocol for 12 weeks with weekly (once per week) treatment sessions completed remotely (via telehealth) and 3 days of home practice per week.
干预措施: Remote sEMG-biofeedback
Standard-of-Care (SOC) Swallow Treatment
The treatment group assigned to the SOC service delivery will complete the same standardized swallowing rehabilitation protocol and in the same frequency as the i-Phagia groups but without the device. That is, they will complete the protocol for 12 weeks with weekly (once per week) treatment sessions completed in-person and 3 days of home practice per week.
干预措施: Standard-of-care treatment
结局指标
主要结局
Penetration-Aspiration Scale (PAS)
时间窗: Pre-treatment; up to 1 week post-treatment; and at a 12-week follow-up
The Penetration Aspiration Scale (PAS) is an 8-point scale, where 1 indicates a completely safe swallow without any penetration or aspiration present, and 8 indicates the most severe degree of aspiration with no attempt to clear the aspirated material. The PAS will be rated by trained investigators blinded to group/arm and time.
Functional Oral Intake Scale (FOIS)
时间窗: Pre-treatment; up to 1 week post-treatment; and at a 12-week follow-up
The Functional Oral Intake Scale (FOIS) is a 7-point ordinal scale (1 indicating nothing by mouth-NPO; and 7 indicating eating without restrictions). It will be rated by the evaluating speech-language pathologist/investigator based on patient report of current diet, to assess functional ability for oral intake.
Normalized sEMG amplitude
时间窗: Pre-treatment; up to 1 week post-treatment; and at a 12-week follow-up
Normalized surface electromyography (sEMG) amplitude values during standardized swallow tasks and maneuvers will be collected at the evaluation time points. The sEMG data will be analyzed by blinded to group/arm and time investigators using a custom-made EMG analysis Matlab script.
次要结局
- Swallowing-related Quality of Life (SWAL-QOL)(Pre-treatment; up to 1 week post-treatment; and at a 12-week follow-up)
- Patient Satisfaction(From date of treatment initiation until the date of the post-treatment evaluation, assessed up to 13 weeks)
- Treatment adherence(From date of treatment initiation until the date of the post-treatment evaluation, assessed up to 13 weeks)