4006-776-356 出国就医服务电话

免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Sensory Augmentation Methods in Stroke (SAM)

Sensory Augmentation Methods in Stroke (SAM)

Study Description
Brief Summary:
Many chronic stroke survivors have poor walking balance, contributing to an increased risk of falls and fear of falling. One factor contributing to these balance deficits is a reduced ability to place the feet appropriately when walking. This study investigates whether enhancing the sensory information available to chronic stroke survivors while they walk improves their foot placement accuracy and balance.

Condition or disease Intervention/treatment Phase
Stroke Behavioral: Sensory Augmentation Behavioral: Random Vibration Early Phase 1

Detailed Description:
The objective of this project is to test a method of providing real-time augmentation of hip proprioceptive feedback during post-stroke walking. The sensory information available to participants will be augmented by providing vibration of the hip abductor musculature that is scaled to the near-real-time mechanical state of their body. The central hypothesis is that augmented proprioception will improve participants' perception of their body's motion, thus increasing the mechanics-dependent modulation of step width, an important gait stabilization strategy. This clinical trial will establish the safety, feasibility, and efficacy of a rehabilitation intervention centered on repeated exposure to sensory augmentation during gait. Specifically, participants in the experimental group will complete training sessions twice a week for four weeks in which they receive sensory augmentation during ~30 minutes of treadmill walking. Participants in the activity-matched control group will perform the same task, except the hip vibration will be randomly delivered, not linked to the body's actual mechanical state. Changes in walking balance and foot placement accuracy will be quantified over the course of the intervention.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomly assigned to either an Experimental (n=22) or Control (n=22) group. These groups will differ only in terms of how vibration is delivered to the hip musculature during training sessions. In the Experimental group, vibration magnitude will be controlled by the real-time mechanical state of the user's body. In the Control group, vibration magnitude will be randomly varied.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Development of Sensory Augmentation Methods to Improve Post-stroke Gait Stability
Estimated Study Start Date : February 1, 2022
Estimated Primary Completion Date : July 1, 2023
Estimated Study Completion Date : September 29, 2023
Arms and Interventions
Arm Intervention/treatment
Experimental: Sensory augmentation
Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration delivered over the hip abductor musculature will scale with the mechanical state of the pelvis at the start of each step. For example, if the step begins with the pelvis far mediolaterally from the stance foot, the swing leg hip abductors will receive strong vibration. If instead the step begins with the pelvis close mediolaterally to the stance foot, the stance hip abductors will receive strong vibration.
 Behavioral: Sensory Augmentation
Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration delivered over the hip abductor musculature will scale with the mechanical state of the pelvis at the start of each step. For example, if the step begins with the pelvis far mediolaterally from the stance foot, the swing leg hip abductors will receive strong vibration. If instead the step begins with the pelvis close mediolaterally to the stance foot, the stance hip abductors will receive strong vibration.
Active Comparator: Random vibration
Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration applied to the hip abductors will vary randomly (following a normal distribution) on a step-by-step basis.
 Behavioral: Random Vibration
Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration applied to the hip abductors will vary randomly (following a normal distribution) on a step-by-step basis.
Outcome Measures
Primary Outcome Measures :
  1. Intervention Safety [ Time Frame: Cumulative over the course of the 4-week intervention ]
    The investigators will monitor the safety of the intervention by quantifying the proportion of participants who experience an adverse event potentially related to the intervention (e.g. skin irritation; falls) or any serious adverse event (e.g. hospitalization; death).

  2. Intervention Feasibility (adherence) [ Time Frame: Cumulative over the course of the 4-week intervention ]
    The investigators will assess participant adherence as the percentage of training sessions attended.

  3. Intervention Feasibility (drop-out) [ Time Frame: 4-weeks ]
    The investigators will assess participant drop-out as the percentage of participants who do not attend the final Assessment Session.

  4. Change in mechanics-dependent adjustment of paretic step width [ Time Frame: 4-weeks ]
    The primary effectiveness measure will be the change in participants' gait stabilization strategy over the course of the 4-week intervention. This will be quantified as the partial correlation between paretic step width and mediolateral pelvis displacement at the start of the step over a 2-minute period of walking. The investigators will calculate the change in this metric from initial (Week 0) assessment session to the final (Week 4) assessment session.


Secondary Outcome Measures :
  1. Intervention Feasibility (walking time) [ Time Frame: Cumulative over the course of the 4-week intervention ]
    The investigators will quantify the total walking time across all training sessions (out of a maximum possible 312 minutes).

  2. Change in fear of falling [ Time Frame: 4-weeks ]
    The investigators will assess the change in fear of falling (identified using a yes/no question of "do you have a fear of falling?") from the initial (Week 0) assessment session to the final (Week 4) assessment session.

  3. Change in Functional Gait Assessment score [ Time Frame: 4-weeks ]
    The investigators will quantify the change in Functional Gait Assessment score from the initial (Week 0) assessment session to the final (Week 4) assessment session.

  4. Change in Activity-specific Balance Confidence score [ Time Frame: 4-weeks ]
    The investigators will quantify the change in Activity-specific Balance Confidence score from the initial (Week 0) assessment session to the final (Week 4) assessment session.

  5. Change in overground self-selected gait speed [ Time Frame: 4-weeks ]
    The investigators will quantify the change in overground self-selected gait speed from the initial (Week 0) assessment session to the final (Week 4) assessment session.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Experience of a stroke 6 months prior to participation
  • Gait speed of at least 0.2 m/s
  • Ability to walk on a treadmill without a cane or walker
  • Provision of informed consent

Exclusion Criteria:

  • Evidence of cerebellar damage
  • Resting blood pressure higher than 220/110 mm Hg
  • History of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living
  • Preexisting neurological disorders or dementia
  • Legal blindness or severe visual impairment
  • History of DVT or pulmonary embolism within 6 months
  • Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions
  • Orthopedic injuries or conditions (e.g. joint replacements) in the lower extremities with the potential to alter the gait pattern
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Jesse C Dean, PhD (843) 792-9566 Jesse.Dean@va.gov

Locations
Layout table for location information
United States, South Carolina
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, United States, 29401-5799
Contact: Jesse C Dean, PhD    843-792-9566    Jesse.Dean@va.gov   
Principal Investigator: Jesse C. Dean, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Layout table for investigator information
Principal Investigator: Jesse C. Dean, PhD Ralph H. Johnson VA Medical Center, Charleston, SC
Tracking Information
First Submitted Date  ICMJE June 14, 2019
First Posted Date  ICMJE June 17, 2019
Last Update Posted Date April 8, 2021
Estimated Study Start Date  ICMJE February 1, 2022
Estimated Primary Completion Date July 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2019)
  • Intervention Safety [ Time Frame: Cumulative over the course of the 4-week intervention ]
    The investigators will monitor the safety of the intervention by quantifying the proportion of participants who experience an adverse event potentially related to the intervention (e.g. skin irritation; falls) or any serious adverse event (e.g. hospitalization; death).
  • Intervention Feasibility (adherence) [ Time Frame: Cumulative over the course of the 4-week intervention ]
    The investigators will assess participant adherence as the percentage of training sessions attended.
  • Intervention Feasibility (drop-out) [ Time Frame: 4-weeks ]
    The investigators will assess participant drop-out as the percentage of participants who do not attend the final Assessment Session.
  • Change in mechanics-dependent adjustment of paretic step width [ Time Frame: 4-weeks ]
    The primary effectiveness measure will be the change in participants' gait stabilization strategy over the course of the 4-week intervention. This will be quantified as the partial correlation between paretic step width and mediolateral pelvis displacement at the start of the step over a 2-minute period of walking. The investigators will calculate the change in this metric from initial (Week 0) assessment session to the final (Week 4) assessment session.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2019)
  • Intervention Feasibility (walking time) [ Time Frame: Cumulative over the course of the 4-week intervention ]
    The investigators will quantify the total walking time across all training sessions (out of a maximum possible 312 minutes).
  • Change in fear of falling [ Time Frame: 4-weeks ]
    The investigators will assess the change in fear of falling (identified using a yes/no question of "do you have a fear of falling?") from the initial (Week 0) assessment session to the final (Week 4) assessment session.
  • Change in Functional Gait Assessment score [ Time Frame: 4-weeks ]
    The investigators will quantify the change in Functional Gait Assessment score from the initial (Week 0) assessment session to the final (Week 4) assessment session.
  • Change in Activity-specific Balance Confidence score [ Time Frame: 4-weeks ]
    The investigators will quantify the change in Activity-specific Balance Confidence score from the initial (Week 0) assessment session to the final (Week 4) assessment session.
  • Change in overground self-selected gait speed [ Time Frame: 4-weeks ]
    The investigators will quantify the change in overground self-selected gait speed from the initial (Week 0) assessment session to the final (Week 4) assessment session.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sensory Augmentation Methods in Stroke
Official Title  ICMJE Development of Sensory Augmentation Methods to Improve Post-stroke Gait Stability
Brief Summary Many chronic stroke survivors have poor walking balance, contributing to an increased risk of falls and fear of falling. One factor contributing to these balance deficits is a reduced ability to place the feet appropriately when walking. This study investigates whether enhancing the sensory information available to chronic stroke survivors while they walk improves their foot placement accuracy and balance.
Detailed Description The objective of this project is to test a method of providing real-time augmentation of hip proprioceptive feedback during post-stroke walking. The sensory information available to participants will be augmented by providing vibration of the hip abductor musculature that is scaled to the near-real-time mechanical state of their body. The central hypothesis is that augmented proprioception will improve participants' perception of their body's motion, thus increasing the mechanics-dependent modulation of step width, an important gait stabilization strategy. This clinical trial will establish the safety, feasibility, and efficacy of a rehabilitation intervention centered on repeated exposure to sensory augmentation during gait. Specifically, participants in the experimental group will complete training sessions twice a week for four weeks in which they receive sensory augmentation during ~30 minutes of treadmill walking. Participants in the activity-matched control group will perform the same task, except the hip vibration will be randomly delivered, not linked to the body's actual mechanical state. Changes in walking balance and foot placement accuracy will be quantified over the course of the intervention.
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participants will be randomly assigned to either an Experimental (n=22) or Control (n=22) group. These groups will differ only in terms of how vibration is delivered to the hip musculature during training sessions. In the Experimental group, vibration magnitude will be controlled by the real-time mechanical state of the user's body. In the Control group, vibration magnitude will be randomly varied.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Stroke
Intervention  ICMJE
  • Behavioral: Sensory Augmentation
    Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration delivered over the hip abductor musculature will scale with the mechanical state of the pelvis at the start of each step. For example, if the step begins with the pelvis far mediolaterally from the stance foot, the swing leg hip abductors will receive strong vibration. If instead the step begins with the pelvis close mediolaterally to the stance foot, the stance hip abductors will receive strong vibration.
  • Behavioral: Random Vibration
    Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration applied to the hip abductors will vary randomly (following a normal distribution) on a step-by-step basis.
Study Arms  ICMJE
  • Experimental: Sensory augmentation
    Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration delivered over the hip abductor musculature will scale with the mechanical state of the pelvis at the start of each step. For example, if the step begins with the pelvis far mediolaterally from the stance foot, the swing leg hip abductors will receive strong vibration. If instead the step begins with the pelvis close mediolaterally to the stance foot, the stance hip abductors will receive strong vibration.
    Intervention: Behavioral: Sensory Augmentation
  • Active Comparator: Random vibration
    Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration applied to the hip abductors will vary randomly (following a normal distribution) on a step-by-step basis.
    Intervention: Behavioral: Random Vibration
Publications * Not Provided

*   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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 14, 2019) 		44
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 29, 2023
Estimated Primary Completion Date July 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Experience of a stroke 6 months prior to participation
  • Gait speed of at least 0.2 m/s
  • Ability to walk on a treadmill without a cane or walker
  • Provision of informed consent

Exclusion Criteria:

  • Evidence of cerebellar damage
  • Resting blood pressure higher than 220/110 mm Hg
  • History of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living
  • Preexisting neurological disorders or dementia
  • Legal blindness or severe visual impairment
  • History of DVT or pulmonary embolism within 6 months
  • Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions
  • Orthopedic injuries or conditions (e.g. joint replacements) in the lower extremities with the potential to alter the gait pattern
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jesse C Dean, PhD (843) 792-9566 Jesse.Dean@va.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03988400
Other Study ID Numbers  ICMJE A3146-R
Has Data Monitoring Committee Yes
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.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: De-identified participant data from the assessment sessions (Week 0 and Week 4) will be shared. Specifically, this will include gait biomechanics data (e.g. the partial correlation between step width and mediolateral pelvis displacement), Functional Gait Assessment scores, Activity-specific Balance Confidence scores, overground gait speeds, and self-reported fear of falling.
Supporting Materials: Study Protocol
Time Frame: Data will be shared 1-month following publication of summary data, and will be shared in perpetuity.
Access Criteria: No criteria are anticipated to restrict who de-identified data will be shared with.
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jesse C. Dean, PhD Ralph H. Johnson VA Medical Center, Charleston, SC
PRS Account VA Office of Research and Development
Verification Date April 2021

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

治疗医院

新药特效药

前沿医讯