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出境医 / 临床实验 / Tongue Pressure Resistance Training for Swallowing Impairment Post-Stroke (TPRT-SIPS)

Tongue Pressure Resistance Training for Swallowing Impairment Post-Stroke (TPRT-SIPS)

Study Description
Brief Summary:
For patients who have suffered a stroke, tongue strength may be decreased compared to healthy individuals. Research on strengthening the tongue in the stroke population has shown positive effects of a tongue resistance training protocol. Research also suggests that swallow safety, or protection of the airway, may be improved as a result of such interventions, however the mechanism of improvement remains poorly understood. This study aims to determine what aspects of the swallowing mechanism (response time, movement, etc. of different structures) are directly impacted in order to provide guidance to clinicians using such treatments.

Condition or disease Intervention/treatment Phase
Stroke Dysphagia Behavioral: Tongue Pressure Resistance Training Not Applicable

Detailed Description:

Swallowing dysfunction (dysphagia) following stroke results from damage to sensory and motor nerve pathways, impairing muscular physiology and impacting swallow timeliness and airway closure. People with dysphagia experience impaired swallowing safety (entry of food or liquid into the airway - aspiration) and/or impaired swallowing efficiency (food or liquid remaining in the oropharyngeal cavities after the swallow - residue). People with dysphagia following stroke are more likely to experience aspiration pneumonia, which has been associated with higher mortality rates.

The tongue functions to contain food and liquid within the oral cavity before the bolus moves into the pharynx. The tongue generates the primary driving forces, which carry the bolus through the pharynx; consequently, impairments in tongue function can affect both swallowing safety and efficiency. For people who have experienced a stroke, lingual strength is decreased compared to healthy participants. Tongue pressure resistance training has been utilized as an intervention in this population, and has been shown to positively influence tongue strength. It remains unclear whether changes in tongue pressure impact swallowing mechanisms, safety, and efficiency for patients who complete these interventions. In particular, the impact of tongue pressure resistance training on swallow timeliness (swallow onset timing, airway closure reaction time, speed of hyolaryngeal movement) remains unknown. This study will be a randomized trial of tongue pressure resistance training in people with tongue weakness and impaired swallowing safety post-stroke. The goal is to understand the physiological changes that occur as an outcome of tongue pressure resistance training and their relationship to swallowing safety and efficiency. Additionally, the impact of a training protocol involving a home practice component to delineate the impact of patient-driven practice will be explored.

A sample of approximately 40 patients will be enrolled. Participants will complete an 8-week program involving a 4-week course of tongue-pressure resistance training and a 4-week no-treatment phase. Participants will be randomized either to an immediate treatment group (followed by a 4-week post-treatment detraining phase) or to a delayed treatment group involving a 4-week waiting period prior to beginning training. Swallowing outcomes will be measured based on videofluoroscopic swallowing studies (VFSS) performed at baseline, 4-weeks and 8-weeks post enrollment. The tongue pressure resistance training program will involve practice of tongue-palate pressure generation tasks and swallowing tasks, with biofeedback provided using the Iowa Oral Performance Instrument (IOPI).

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized crossover trial
Masking: Single (Outcomes Assessor)
Masking Description: Blinding procedures will be taken to minimize bias - Raters extracting data from VFSS studies will also be blinded to participant allocation, VFSS time-point (pre vs post treatment), time post stroke, and bolus consistency. Each VFSS will be de-identified and converted so that all audio collected during the study will be removed to avoid revealing information to the blinded raters.
Primary Purpose: Treatment
Official Title: Tongue Pressure Resistance Training for Swallowing Impairment Post-Stroke
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Immediate
Participants in the immediate intervention arm will begin a 4-week intervention tongue pressure resistance training protocol within 10 days of their baseline Videofluoroscopic Swallowing Evaluation assessment, with 2 face-to-face 1-hour visits per week under direct supervision of a speech-language pathologist. These treatment sessions will be supplemented by daily home practice of the intervention.
Behavioral: Tongue Pressure Resistance Training
2 supervised sessions per week: Each session will be a maximum of one hour in length and will include: 1) 20 repetitions of maximum isometric presses (MIPs) with rapid rise in pressure at the anterior location. 2) 15 regular saliva swallows with the IOPI bulb in place. 3)15 effortful saliva swallows with the IOPI bulb in place. 4) 10 generalization tasks with mildly thick liquid and IOPI.
Other Name: Iowa Oral Performance Instrument

Active Comparator: Delayed
Participants in the delayed intervention arm will begin their involvement with a 4-week waiting period after the baseline Videofluoroscopic Swallowing Evaluation. Treatment will commence after the second Videofluoroscopic Swallowing Evaluation and will follow the same schedule for the tongue pressure resistance training, supplemented by daily home practice.
Behavioral: Tongue Pressure Resistance Training
2 supervised sessions per week: Each session will be a maximum of one hour in length and will include: 1) 20 repetitions of maximum isometric presses (MIPs) with rapid rise in pressure at the anterior location. 2) 15 regular saliva swallows with the IOPI bulb in place. 3)15 effortful saliva swallows with the IOPI bulb in place. 4) 10 generalization tasks with mildly thick liquid and IOPI.
Other Name: Iowa Oral Performance Instrument

Outcome Measures
Primary Outcome Measures :
  1. Penetration-Aspiration Scale [PAS] [ Time Frame: Pre-treatment baseline, 4 weeks after baseline, 8 weeks after baseline ]
    Change in swallowing safety on thin and mildly thick liquid swallows. The maximum PAS score per consistency will be collected.

  2. Number of swallows per bolus [ Time Frame: Pre-treatment baseline, 4 weeks after baseline, 8 weeks after baseline ]
    Change in swallowing efficiency on thin and mildly thick liquid swallows. The maximum number of swallows per bolus for each consistency will be collected.

  3. Pixel-based measurement of post-swallow pharyngeal residue [ Time Frame: Pre-treatment baseline, 4 weeks after baseline, 8 weeks after baseline ]
    Change in swallowing efficiency on thin and mildly thick liquid swallows measured as a % of the C2-C4-squared anatomical reference scalar. The highest value across repeated boluses within a consistency will be collected.

  4. International Dysphagia Diet Standardisation Initiative Functional Diet Scale [ Time Frame: Pre-treatment baseline, 4 weeks after baseline, 8 weeks after baseline ]
    Change in diet texture recommendation (number of diet texture levels allowed from the International Dysphagia Diet Standardisation Initiative Framework).


Secondary Outcome Measures :
  1. Tongue Strength [ Time Frame: Pre-treatment baseline, 4 weeks after baseline, 8 weeks after baseline ]
    Change in maximum isometric tongue pressure, measured using the Iowa Oral performance Instrument. The maximum value of 3 repetitions will be collected.

  2. Saliva Swallow Tongue Pressures [ Time Frame: Pre-treatment baseline, 4 weeks after baseline, 8 weeks after baseline ]
    Change in saliva swallowing pressures, measured using the Iowa Oral Performance Instrument. the maximum value of 3 repetitions will be collected.

  3. Swallow Timing Swallow Timing [ Time Frame: Pre-treatment baseline, 4 weeks after baseline, 8 weeks after baseline ]
    Change in the timing of the hyoid burst onset and time to laryngeal vestibule closure, in milliseconds relative to the frame of the bolus passing the ramus of mandible, during thin and mildly thick liquid swallows measured on videofluoroscopy. The maximum value per consistency will be collected.

  4. Hyoid Kinematics [ Time Frame: Pre-treatment baseline, 4 weeks after baseline, 8 weeks after baseline ]
    Change in peak hyoid position (in anatomically normalized units of distance relative to the C2-C4 reference scalar) during thin and mildly thick liquid swallows measured on videofluoroscopy. The maximum value per consistency will be collected.

  5. Pharyngeal constriction [ Time Frame: Pre-treatment baseline, 4 weeks after baseline, 8 weeks after baseline ]
    Change in pharyngeal constriction (measured as a % of the C2-C4-squared reference scalar) during thin and mildly thick liquid swallows measured on videofluoroscopy. The best (i.e. smallest) value per consistency will be collected.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • English-speaking adults
  • A confirmed diagnosis of ischemic stroke (including hemispheric, cortical or subcortical and excluding cerebellum and brainstem locations within 3 months following the stroke) identified via CT or MRI
  • Eligible participants will display decreased tongue pressure as measured by the Iowa Oral Performance Instrument (IOPI), and show evidence of dysphagia (safety or efficiency concerns) on baseline VFSS with thin or mildly thick liquid stimuli.

Exclusion Criteria:

  • History of head and neck cancer
  • Radical neck dissection (e.g. anterior cervical surgery fusions) or neck/ oropharyngeal surgery (not excluded - tonsillectomy, adenoidectomy, tracheostomy)
  • Past medical history of any neurological disease other than stroke (e.g. Multiple Sclerosis, Parkinson Disease, Amyotrophic Lateral Sclerosis, Traumatic Brain Injury)
  • Oral apraxia, impairing the participant's ability to complete exercises
  • Cognitive or receptive communication difficulties that preclude the participant's ability to follow study instructions
  • Allergies to barium, potato starch, corn starch, xanthan gum, milk products, or latex
Contacts and Locations

Locations
Layout table for location information
United States, Illinois
Marianjoy Hospital
Wheaton, Illinois, United States, 60187
Canada, Ontario
Toronto Rehabilitation Institute - University Health Network
Toronto, Ontario, Canada, M5G 2A2
Sponsors and Collaborators
University Health Network, Toronto
Marianjoy Rehabilitation Hospital & Clinics
Investigators
Layout table for investigator information
Principal Investigator: Catriona Steele KITE - Toronto Rehabilitation Institute - University Health Network
Principal Investigator: Denyse Richardson University Health Network, Toronto
Principal Investigator: Michael Pietrantoni Marianjoy Hospital
Principal Investigator: Susan Brady Marianjoy Hospital
Tracking Information
First Submitted Date  ICMJE May 3, 2019
First Posted Date  ICMJE May 31, 2019
Last Update Posted Date April 2, 2021
Actual Study Start Date  ICMJE April 1, 2019
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2019)
  • Penetration-Aspiration Scale [PAS] [ Time Frame: Pre-treatment baseline, 4 weeks after baseline, 8 weeks after baseline ]
    Change in swallowing safety on thin and mildly thick liquid swallows. The maximum PAS score per consistency will be collected.
  • Number of swallows per bolus [ Time Frame: Pre-treatment baseline, 4 weeks after baseline, 8 weeks after baseline ]
    Change in swallowing efficiency on thin and mildly thick liquid swallows. The maximum number of swallows per bolus for each consistency will be collected.
  • Pixel-based measurement of post-swallow pharyngeal residue [ Time Frame: Pre-treatment baseline, 4 weeks after baseline, 8 weeks after baseline ]
    Change in swallowing efficiency on thin and mildly thick liquid swallows measured as a % of the C2-C4-squared anatomical reference scalar. The highest value across repeated boluses within a consistency will be collected.
  • International Dysphagia Diet Standardisation Initiative Functional Diet Scale [ Time Frame: Pre-treatment baseline, 4 weeks after baseline, 8 weeks after baseline ]
    Change in diet texture recommendation (number of diet texture levels allowed from the International Dysphagia Diet Standardisation Initiative Framework).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2019)
  • Tongue Strength [ Time Frame: Pre-treatment baseline, 4 weeks after baseline, 8 weeks after baseline ]
    Change in maximum isometric tongue pressure, measured using the Iowa Oral performance Instrument. The maximum value of 3 repetitions will be collected.
  • Saliva Swallow Tongue Pressures [ Time Frame: Pre-treatment baseline, 4 weeks after baseline, 8 weeks after baseline ]
    Change in saliva swallowing pressures, measured using the Iowa Oral Performance Instrument. the maximum value of 3 repetitions will be collected.
  • Swallow Timing Swallow Timing [ Time Frame: Pre-treatment baseline, 4 weeks after baseline, 8 weeks after baseline ]
    Change in the timing of the hyoid burst onset and time to laryngeal vestibule closure, in milliseconds relative to the frame of the bolus passing the ramus of mandible, during thin and mildly thick liquid swallows measured on videofluoroscopy. The maximum value per consistency will be collected.
  • Hyoid Kinematics [ Time Frame: Pre-treatment baseline, 4 weeks after baseline, 8 weeks after baseline ]
    Change in peak hyoid position (in anatomically normalized units of distance relative to the C2-C4 reference scalar) during thin and mildly thick liquid swallows measured on videofluoroscopy. The maximum value per consistency will be collected.
  • Pharyngeal constriction [ Time Frame: Pre-treatment baseline, 4 weeks after baseline, 8 weeks after baseline ]
    Change in pharyngeal constriction (measured as a % of the C2-C4-squared reference scalar) during thin and mildly thick liquid swallows measured on videofluoroscopy. The best (i.e. smallest) value per consistency will be collected.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2019)
  • Tongue Strength [ Time Frame: Pre-treatment baseline, 4 weeks after baseline, 8 weeks after baseline ]
    Change in maximum isometric tongue pressure, measured using the Iowa Oral performance Instrument. The maximum value of 3 repetitions will be collected.
  • Saliva Swallow Tongue Pressures [ Time Frame: Pre-treatment baseline, 4 weeks after baseline, 8 weeks after baseline ]
    Change in saliva swallowing pressures, measured using the Iowa Oral Performance Instrument. the maximum value of 3 repetitions will be collected.
  • Swallow Timing Swallow Timing [ Time Frame: Pre-treatment baseline, 4 weeks after baseline, 8 weeks after baseline ]
    Change in the timing of the hyoid burst onset and laryngeal vestibule closure, in milliseconds relative to the frame of the bolus passing the ramus of mandible, during thin and mildly thick liquid swallows measured on videofluoroscopy. The maximum value per consistency will be collected.
  • Hyoid Kinematics [ Time Frame: Pre-treatment baseline, 4 weeks after baseline, 8 weeks after baseline ]
    Change in peak hyoid position (in anatomically normalized units of distance relative to the C2-C4 reference scalar) during thin and mildly thick liquid swallows measured on videofluoroscopy. The maximum value per consistency will be collected.
  • Pharyngeal constriction [ Time Frame: Pre-treatment baseline, 4 weeks after baseline, 8 weeks after baseline ]
    Change in pharyngeal constriction (measured as a % of the C2-C4-squared reference scalar) during thin and mildly thick liquid swallows measured on videofluoroscopy. The best (i.e. smallest) value per consistency will be collected.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tongue Pressure Resistance Training for Swallowing Impairment Post-Stroke
Official Title  ICMJE Tongue Pressure Resistance Training for Swallowing Impairment Post-Stroke
Brief Summary For patients who have suffered a stroke, tongue strength may be decreased compared to healthy individuals. Research on strengthening the tongue in the stroke population has shown positive effects of a tongue resistance training protocol. Research also suggests that swallow safety, or protection of the airway, may be improved as a result of such interventions, however the mechanism of improvement remains poorly understood. This study aims to determine what aspects of the swallowing mechanism (response time, movement, etc. of different structures) are directly impacted in order to provide guidance to clinicians using such treatments.
Detailed Description

Swallowing dysfunction (dysphagia) following stroke results from damage to sensory and motor nerve pathways, impairing muscular physiology and impacting swallow timeliness and airway closure. People with dysphagia experience impaired swallowing safety (entry of food or liquid into the airway - aspiration) and/or impaired swallowing efficiency (food or liquid remaining in the oropharyngeal cavities after the swallow - residue). People with dysphagia following stroke are more likely to experience aspiration pneumonia, which has been associated with higher mortality rates.

The tongue functions to contain food and liquid within the oral cavity before the bolus moves into the pharynx. The tongue generates the primary driving forces, which carry the bolus through the pharynx; consequently, impairments in tongue function can affect both swallowing safety and efficiency. For people who have experienced a stroke, lingual strength is decreased compared to healthy participants. Tongue pressure resistance training has been utilized as an intervention in this population, and has been shown to positively influence tongue strength. It remains unclear whether changes in tongue pressure impact swallowing mechanisms, safety, and efficiency for patients who complete these interventions. In particular, the impact of tongue pressure resistance training on swallow timeliness (swallow onset timing, airway closure reaction time, speed of hyolaryngeal movement) remains unknown. This study will be a randomized trial of tongue pressure resistance training in people with tongue weakness and impaired swallowing safety post-stroke. The goal is to understand the physiological changes that occur as an outcome of tongue pressure resistance training and their relationship to swallowing safety and efficiency. Additionally, the impact of a training protocol involving a home practice component to delineate the impact of patient-driven practice will be explored.

A sample of approximately 40 patients will be enrolled. Participants will complete an 8-week program involving a 4-week course of tongue-pressure resistance training and a 4-week no-treatment phase. Participants will be randomized either to an immediate treatment group (followed by a 4-week post-treatment detraining phase) or to a delayed treatment group involving a 4-week waiting period prior to beginning training. Swallowing outcomes will be measured based on videofluoroscopic swallowing studies (VFSS) performed at baseline, 4-weeks and 8-weeks post enrollment. The tongue pressure resistance training program will involve practice of tongue-palate pressure generation tasks and swallowing tasks, with biofeedback provided using the Iowa Oral Performance Instrument (IOPI).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Randomized crossover trial
Masking: Single (Outcomes Assessor)
Masking Description:
Blinding procedures will be taken to minimize bias - Raters extracting data from VFSS studies will also be blinded to participant allocation, VFSS time-point (pre vs post treatment), time post stroke, and bolus consistency. Each VFSS will be de-identified and converted so that all audio collected during the study will be removed to avoid revealing information to the blinded raters.
Primary Purpose: Treatment
Condition  ICMJE
  • Stroke
  • Dysphagia
Intervention  ICMJE Behavioral: Tongue Pressure Resistance Training
2 supervised sessions per week: Each session will be a maximum of one hour in length and will include: 1) 20 repetitions of maximum isometric presses (MIPs) with rapid rise in pressure at the anterior location. 2) 15 regular saliva swallows with the IOPI bulb in place. 3)15 effortful saliva swallows with the IOPI bulb in place. 4) 10 generalization tasks with mildly thick liquid and IOPI.
Other Name: Iowa Oral Performance Instrument
Study Arms  ICMJE
  • Experimental: Immediate
    Participants in the immediate intervention arm will begin a 4-week intervention tongue pressure resistance training protocol within 10 days of their baseline Videofluoroscopic Swallowing Evaluation assessment, with 2 face-to-face 1-hour visits per week under direct supervision of a speech-language pathologist. These treatment sessions will be supplemented by daily home practice of the intervention.
    Intervention: Behavioral: Tongue Pressure Resistance Training
  • Active Comparator: Delayed
    Participants in the delayed intervention arm will begin their involvement with a 4-week waiting period after the baseline Videofluoroscopic Swallowing Evaluation. Treatment will commence after the second Videofluoroscopic Swallowing Evaluation and will follow the same schedule for the tongue pressure resistance training, supplemented by daily home practice.
    Intervention: Behavioral: Tongue Pressure Resistance Training
Publications *
  • Cho YS, Oh DH, Paik YR, Lee JH, Park JS. Effects of bedside self-exercise on oropharyngeal swallowing function in stroke patients with dysphagia: a pilot study. J Phys Ther Sci. 2017 Oct;29(10):1815-1816. doi: 10.1589/jpts.29.1815. Epub 2017 Oct 21.
  • Hori K, Ono T, Iwata H, Nokubi T, Kumakura I. Tongue pressure against hard palate during swallowing in post-stroke patients. Gerodontology. 2005 Dec;22(4):227-33.
  • Kim HD, Choi JB, Yoo SJ, Chang MY, Lee SW, Park JS. Tongue-to-palate resistance training improves tongue strength and oropharyngeal swallowing function in subacute stroke survivors with dysphagia. J Oral Rehabil. 2017 Jan;44(1):59-64. doi: 10.1111/joor.12461.
  • Mann G, Hankey GJ, Cameron D. Swallowing function after stroke: prognosis and prognostic factors at 6 months. Stroke. 1999 Apr;30(4):744-8.
  • Martino R, Foley N, Bhogal S, Diamant N, Speechley M, Teasell R. Dysphagia after stroke: incidence, diagnosis, and pulmonary complications. Stroke. 2005 Dec;36(12):2756-63. Epub 2005 Nov 3. Review.
  • McKenna VS, Zhang B, Haines MB, Kelchner LN. A Systematic Review of Isometric Lingual Strength-Training Programs in Adults With and Without Dysphagia. Am J Speech Lang Pathol. 2017 May 17;26(2):524-539. doi: 10.1044/2016_AJSLP-15-0051. Review.
  • Park JS, Kim HJ, Oh DH. Effect of tongue strength training using the Iowa Oral Performance Instrument in stroke patients with dysphagia. J Phys Ther Sci. 2015 Dec;27(12):3631-4. doi: 10.1589/jpts.27.3631. Epub 2015 Dec 28.
  • Robbins J, Kays SA, Gangnon RE, Hind JA, Hewitt AL, Gentry LR, Taylor AJ. The effects of lingual exercise in stroke patients with dysphagia. Arch Phys Med Rehabil. 2007 Feb;88(2):150-8.
  • Steele CM, Bayley MT, Peladeau-Pigeon M, Nagy A, Namasivayam AM, Stokely SL, Wolkin T. A Randomized Trial Comparing Two Tongue-Pressure Resistance Training Protocols for Post-Stroke Dysphagia. Dysphagia. 2016 Jun;31(3):452-61. doi: 10.1007/s00455-016-9699-5. Epub 2016 Mar 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: May 28, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2021
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • English-speaking adults
  • A confirmed diagnosis of ischemic stroke (including hemispheric, cortical or subcortical and excluding cerebellum and brainstem locations within 3 months following the stroke) identified via CT or MRI
  • Eligible participants will display decreased tongue pressure as measured by the Iowa Oral Performance Instrument (IOPI), and show evidence of dysphagia (safety or efficiency concerns) on baseline VFSS with thin or mildly thick liquid stimuli.

Exclusion Criteria:

  • History of head and neck cancer
  • Radical neck dissection (e.g. anterior cervical surgery fusions) or neck/ oropharyngeal surgery (not excluded - tonsillectomy, adenoidectomy, tracheostomy)
  • Past medical history of any neurological disease other than stroke (e.g. Multiple Sclerosis, Parkinson Disease, Amyotrophic Lateral Sclerosis, Traumatic Brain Injury)
  • Oral apraxia, impairing the participant's ability to complete exercises
  • Cognitive or receptive communication difficulties that preclude the participant's ability to follow study instructions
  • Allergies to barium, potato starch, corn starch, xanthan gum, milk products, or latex
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03969095
Other Study ID Numbers  ICMJE 18-6172.1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Catriona Steele, University Health Network, Toronto
Study Sponsor  ICMJE University Health Network, Toronto
Collaborators  ICMJE Marianjoy Rehabilitation Hospital & Clinics
Investigators  ICMJE
Principal Investigator: Catriona Steele KITE - Toronto Rehabilitation Institute - University Health Network
Principal Investigator: Denyse Richardson University Health Network, Toronto
Principal Investigator: Michael Pietrantoni Marianjoy Hospital
Principal Investigator: Susan Brady Marianjoy Hospital
PRS Account University Health Network, Toronto
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP