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 / Innovative Biofeedback Interface for Enhancing Stroke Gait Rehabilitation

Innovative Biofeedback Interface for Enhancing Stroke Gait Rehabilitation

Study Description
Brief Summary:

This study will conduct a preliminary evaluation of and obtain user data on a novel game-based visual interface for stroke gait training. Study participants will complete one session comprising exposure to gait biofeedback systems in an order determined by block randomization (3 blocks). Participants will be exposed to 3 types of biofeedback interfaces:

  • the anterior ground reaction forces (AGRF) biofeedback game (projector-display, non-augmented reality [AR])
  • AR version of the biofeedback game (head-mounted AR display)
  • traditional, non-game-based, interface

Condition or disease Intervention/treatment Phase
Gait, Hemiplegic Stroke Other: Game without AR Other: Game with AR Other: Traditional Biofeedback Interface Not Applicable

Detailed Description:

Stroke is the leading cause of adult disability. Even after discharge from rehabilitation, residual gait deficits are prevalent in stroke survivors, leading to decreased walking speed and endurance. Because gait dysfunctions limit community mobility, stroke survivors and rehabilitation clinicians consider restoration of walking a major goal of rehabilitation. Several challenges and research gaps limit the effectiveness of current clinical gait rehabilitation practices. While there is consensus that stroke survivors benefit from gait rehabilitation, agreement is lacking on which specific training interventions are most efficacious. The long-term goal of this proposal is to address these challenges by developing personalized, engaging, salient gait training treatments founded on evidence from neuroscience, biomechanics, motor learning, and gaming.

Real-time biofeedback is a promising gait training intervention for targeting specific biomechanical impairments. Biofeedback can enhance an individual's awareness of the impairment targeted during gait training, enabling self-correction of aberrant gait patterns.

In response to treadmill training combined with visual and auditory real-time biofeedback, able-bodied individuals can increase AGRF unilaterally for the targeted limb. Thus, AGRF biofeedback may be a beneficial strategy to target unilateral propulsive deficits in people post-stroke. Incorporation of gaming interfaces for gait biofeedback can increase patient motivation, distract participants from fatigue or boredom, and encourage greater numbers of repetitions during gait training.

The long-term goal of this study is to develop a more engaging, motivating gait biofeedback methodologies specifically designed for post-stroke gait training. The researchers aim to address a major challenge for rehabilitation clinicians - to make gait training appealing and meaningful so that patients engage in sufficient repetitions, intensity, and challenge to maximize therapeutic effectiveness. The study premise is that post-stroke individuals will demonstrate greater engagement, motivation, and therapeutic benefits during gait training sessions involving biofeedback when training incorporates intuitive, entertaining, game-based interfaces. Outcomes of the study will include measures of participant engagement, user-reports and survey-responses on motivation, fatigue, game characteristics, and adverse effects (e.g. nausea, dizziness) during game exposure. In addition to this clinical trial with stroke survivor participants, data about the game interface will be collected by having able-bodied neuro-rehabilitation clinicians try the 3 types of biofeedback interventions.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 12 post-stroke individuals will complete 3 different biofeedback interfaces in random order.
Masking: Single (Outcomes Assessor)
Masking Description: The study outcomes will be collected by an evaluator (licensed physical therapist) who was not involved in study design and is blinded to the biofeedback assignment/order.
Primary Purpose: Treatment
Official Title: Innovative Biofeedback Interface for Enhancing Stroke Gait Rehabilitation
Estimated Study Start Date : May 2021
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021
Arms and Interventions
Arm Intervention/treatment
Game without AR, Game with AR, Traditional Interface
Post-stroke participants randomized to receive the three gait training biofeedback interfaces in the order of: game without AR, game with AR, traditional interface
Other: Game without AR
During the AGRF biofeedback game without augmented reality (AR) participants will walk on a split-belt treadmill with a projector-display. Participants will be receiving real-time information or feedback about ongoing gait performance parameters while they are walking. The participants will be exposed to the AGRF biofeedback game without AR for 6 minutes.
Other Name: gait training

Other: Game with AR
During the AGRF biofeedback game with augmented reality (AR) participants will walk on a split-belt treadmill with a head-mounted AR display. Participants will be receiving real-time information or feedback about ongoing gait performance parameters while they are walking. The participants will be exposed to the AGRF biofeedback game with AR for 6 minutes.
Other Name: gait training

Other: Traditional Biofeedback Interface
For the traditional non-game biofeedback, the visual display comprises a horizontal line graph with a moveable cursor that represents the current measured value of antero-posterior ground reaction force for the targeted leg. The auditory feedback comprises an audible "beep" produced every time the cursor entered the target range. Participants will be exposed to the traditional biofeedback interface for 6 minutes.
Other Name: gait training

Game without AR, Traditional Interface, Game with AR
Post-stroke participants randomized to receive the three gait training biofeedback interfaces in the order of: game without AR, traditional interface, game with AR
Other: Game without AR
During the AGRF biofeedback game without augmented reality (AR) participants will walk on a split-belt treadmill with a projector-display. Participants will be receiving real-time information or feedback about ongoing gait performance parameters while they are walking. The participants will be exposed to the AGRF biofeedback game without AR for 6 minutes.
Other Name: gait training

Other: Game with AR
During the AGRF biofeedback game with augmented reality (AR) participants will walk on a split-belt treadmill with a head-mounted AR display. Participants will be receiving real-time information or feedback about ongoing gait performance parameters while they are walking. The participants will be exposed to the AGRF biofeedback game with AR for 6 minutes.
Other Name: gait training

Other: Traditional Biofeedback Interface
For the traditional non-game biofeedback, the visual display comprises a horizontal line graph with a moveable cursor that represents the current measured value of antero-posterior ground reaction force for the targeted leg. The auditory feedback comprises an audible "beep" produced every time the cursor entered the target range. Participants will be exposed to the traditional biofeedback interface for 6 minutes.
Other Name: gait training

Game with AR, Game without AR, Traditional Interface
Post-stroke participants randomized to receive the three gait training biofeedback interfaces in the order of: game with AR, game without AR, traditional interface
Other: Game without AR
During the AGRF biofeedback game without augmented reality (AR) participants will walk on a split-belt treadmill with a projector-display. Participants will be receiving real-time information or feedback about ongoing gait performance parameters while they are walking. The participants will be exposed to the AGRF biofeedback game without AR for 6 minutes.
Other Name: gait training

Other: Game with AR
During the AGRF biofeedback game with augmented reality (AR) participants will walk on a split-belt treadmill with a head-mounted AR display. Participants will be receiving real-time information or feedback about ongoing gait performance parameters while they are walking. The participants will be exposed to the AGRF biofeedback game with AR for 6 minutes.
Other Name: gait training

Other: Traditional Biofeedback Interface
For the traditional non-game biofeedback, the visual display comprises a horizontal line graph with a moveable cursor that represents the current measured value of antero-posterior ground reaction force for the targeted leg. The auditory feedback comprises an audible "beep" produced every time the cursor entered the target range. Participants will be exposed to the traditional biofeedback interface for 6 minutes.
Other Name: gait training

Game with AR, Traditional Interface, Game without AR
Post-stroke participants randomized to receive the three gait training biofeedback interfaces in the order of: game with AR, traditional interface, game without AR
Other: Game without AR
During the AGRF biofeedback game without augmented reality (AR) participants will walk on a split-belt treadmill with a projector-display. Participants will be receiving real-time information or feedback about ongoing gait performance parameters while they are walking. The participants will be exposed to the AGRF biofeedback game without AR for 6 minutes.
Other Name: gait training

Other: Game with AR
During the AGRF biofeedback game with augmented reality (AR) participants will walk on a split-belt treadmill with a head-mounted AR display. Participants will be receiving real-time information or feedback about ongoing gait performance parameters while they are walking. The participants will be exposed to the AGRF biofeedback game with AR for 6 minutes.
Other Name: gait training

Other: Traditional Biofeedback Interface
For the traditional non-game biofeedback, the visual display comprises a horizontal line graph with a moveable cursor that represents the current measured value of antero-posterior ground reaction force for the targeted leg. The auditory feedback comprises an audible "beep" produced every time the cursor entered the target range. Participants will be exposed to the traditional biofeedback interface for 6 minutes.
Other Name: gait training

Traditional Interface, Game without AR, Game with AR
Post-stroke participants randomized to receive the three gait training biofeedback interfaces in the order of: traditional interface, game without AR, game with AR
Other: Game without AR
During the AGRF biofeedback game without augmented reality (AR) participants will walk on a split-belt treadmill with a projector-display. Participants will be receiving real-time information or feedback about ongoing gait performance parameters while they are walking. The participants will be exposed to the AGRF biofeedback game without AR for 6 minutes.
Other Name: gait training

Other: Game with AR
During the AGRF biofeedback game with augmented reality (AR) participants will walk on a split-belt treadmill with a head-mounted AR display. Participants will be receiving real-time information or feedback about ongoing gait performance parameters while they are walking. The participants will be exposed to the AGRF biofeedback game with AR for 6 minutes.
Other Name: gait training

Other: Traditional Biofeedback Interface
For the traditional non-game biofeedback, the visual display comprises a horizontal line graph with a moveable cursor that represents the current measured value of antero-posterior ground reaction force for the targeted leg. The auditory feedback comprises an audible "beep" produced every time the cursor entered the target range. Participants will be exposed to the traditional biofeedback interface for 6 minutes.
Other Name: gait training

Traditional Interface, Game with AR, Game without AR
Post-stroke participants randomized to receive the three gait training biofeedback interfaces in the order of: traditional interface, game with AR, game without AR
Other: Game without AR
During the AGRF biofeedback game without augmented reality (AR) participants will walk on a split-belt treadmill with a projector-display. Participants will be receiving real-time information or feedback about ongoing gait performance parameters while they are walking. The participants will be exposed to the AGRF biofeedback game without AR for 6 minutes.
Other Name: gait training

Other: Game with AR
During the AGRF biofeedback game with augmented reality (AR) participants will walk on a split-belt treadmill with a head-mounted AR display. Participants will be receiving real-time information or feedback about ongoing gait performance parameters while they are walking. The participants will be exposed to the AGRF biofeedback game with AR for 6 minutes.
Other Name: gait training

Other: Traditional Biofeedback Interface
For the traditional non-game biofeedback, the visual display comprises a horizontal line graph with a moveable cursor that represents the current measured value of antero-posterior ground reaction force for the targeted leg. The auditory feedback comprises an audible "beep" produced every time the cursor entered the target range. Participants will be exposed to the traditional biofeedback interface for 6 minutes.
Other Name: gait training

Outcome Measures
Primary Outcome Measures :
  1. Change in Pittsburgh Rehabilitation Participation Scale (PRPS) Score [ Time Frame: Day 1, after each of the three biofeedback interface sessions ]
    The PRPS is a single-item, clinician-rated instrument assessing the participant's engagement during each biofeedback bout. The level of participation is scored on a scale from 1 (none) to 6 (excellent), with higher values indicating greater participation in the therapy session.

  2. Change in Boredom [ Time Frame: Day 1, after each of the three biofeedback interface sessions ]
    Boredom will be assessed by 10-point visual analog scale asking participants to rate how bored they felt during the walk, where 1 is not bored and 10 is very bored.

  3. Success rate of target paretic AGRF [ Time Frame: Day 1, after each of the three biofeedback interface sessions ]
    The success rate of the targeted training task will be assessed as the percentage of steps for which the target paretic AGRF was achieved.


Secondary Outcome Measures :
  1. Change in Fatigue [ Time Frame: Day 1, after each of the three biofeedback interface sessions ]
    Fatigue will be assessed by 10-point visual analog scale asking participants to rate how tired they felt during the walk, where 1 is not fatigued and 10 is very fatigued.

  2. Change in Hopkins Rehabilitation Engagement Rating Scale (HRERS) Score [ Time Frame: Day 1, after each of the three biofeedback interface sessions ]
    The HRERS will be used to assess participant engagement during each biofeedback bout. The HRERS is a 5-item instrument where clinicians indicate how engaged the participant was during a rehabilitation session on a 6- point scale ranging from 1 (never) to 6 (always). Total scores range from 5 to 30 with higher scores indicating increased engagement.

  3. Change in Motivation [ Time Frame: Day 1, after each of the three biofeedback interface sessions ]
    Motivation will be assessed by 10-point visual analog scale asking participants to rate how motivated they felt during the walk, where 1 is not motivated and 10 is very motivated.

  4. Game Ease of Use [ Time Frame: Day 1 ]
    User experience of the biofeedback game will be assessed with a 10-point scale asking participants to rate the ease of use, where 1 is very difficult to use and 10 is very easy to use. Participants will also be asked an open-ended survey question requesting comments and feedback about game's features (e.g. "In your opinion, what were the good and bad things about the game's ease of use"?).


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   30 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for Post-Stroke Participants:

  • chronic stroke (>6 months post stroke)
  • ambulatory with or without the use of a cane or walker
  • able to walk for 2 minutes at the self-selected speed without an orthoses
  • resting heart rate 40-100 beats per minute

Exclusion Criteria for Post-Stroke Participants:

  • cerebellar signs (ataxic ("drunken") gait or decreased coordination during rapid alternating hand or foot movements
  • history of lower extremity joint replacement
  • inability to communicate with investigators
  • neglect/hemianopia, or unexplained dizziness in last 6 months
  • neurologic conditions other than stroke
  • orthopedic problems in the lower limbs or spine (or other medical conditions) that limit walking or cause pain during walking
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Trisha Kesar, PT, PhD 404-712-5803 tkesar@emory.edu

Locations
Layout table for location information
United States, Georgia
Emory Rehabilitation Hospital Recruiting
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Layout table for investigator information
Principal Investigator: Trisha Kesar, PT, PhD Emory University
Tracking Information
First Submitted Date  ICMJE July 8, 2019
First Posted Date  ICMJE July 10, 2019
Last Update Posted Date April 13, 2021
Estimated Study Start Date  ICMJE May 2021
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2019)
  • Change in Pittsburgh Rehabilitation Participation Scale (PRPS) Score [ Time Frame: Day 1, after each of the three biofeedback interface sessions ]
    The PRPS is a single-item, clinician-rated instrument assessing the participant's engagement during each biofeedback bout. The level of participation is scored on a scale from 1 (none) to 6 (excellent), with higher values indicating greater participation in the therapy session.
  • Change in Boredom [ Time Frame: Day 1, after each of the three biofeedback interface sessions ]
    Boredom will be assessed by 10-point visual analog scale asking participants to rate how bored they felt during the walk, where 1 is not bored and 10 is very bored.
  • Success rate of target paretic AGRF [ Time Frame: Day 1, after each of the three biofeedback interface sessions ]
    The success rate of the targeted training task will be assessed as the percentage of steps for which the target paretic AGRF was achieved.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2019)
  • Change in Fatigue [ Time Frame: Day 1, after each of the three biofeedback interface sessions ]
    Fatigue will be assessed by 10-point visual analog scale asking participants to rate how tired they felt during the walk, where 1 is not fatigued and 10 is very fatigued.
  • Change in Hopkins Rehabilitation Engagement Rating Scale (HRERS) Score [ Time Frame: Day 1, after each of the three biofeedback interface sessions ]
    The HRERS will be used to assess participant engagement during each biofeedback bout. The HRERS is a 5-item instrument where clinicians indicate how engaged the participant was during a rehabilitation session on a 6- point scale ranging from 1 (never) to 6 (always). Total scores range from 5 to 30 with higher scores indicating increased engagement.
  • Change in Motivation [ Time Frame: Day 1, after each of the three biofeedback interface sessions ]
    Motivation will be assessed by 10-point visual analog scale asking participants to rate how motivated they felt during the walk, where 1 is not motivated and 10 is very motivated.
  • Game Ease of Use [ Time Frame: Day 1 ]
    User experience of the biofeedback game will be assessed with a 10-point scale asking participants to rate the ease of use, where 1 is very difficult to use and 10 is very easy to use. Participants will also be asked an open-ended survey question requesting comments and feedback about game's features (e.g. "In your opinion, what were the good and bad things about the game's ease of use"?).
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 Innovative Biofeedback Interface for Enhancing Stroke Gait Rehabilitation
Official Title  ICMJE Innovative Biofeedback Interface for Enhancing Stroke Gait Rehabilitation
Brief Summary

This study will conduct a preliminary evaluation of and obtain user data on a novel game-based visual interface for stroke gait training. Study participants will complete one session comprising exposure to gait biofeedback systems in an order determined by block randomization (3 blocks). Participants will be exposed to 3 types of biofeedback interfaces:

  • the anterior ground reaction forces (AGRF) biofeedback game (projector-display, non-augmented reality [AR])
  • AR version of the biofeedback game (head-mounted AR display)
  • traditional, non-game-based, interface
Detailed Description

Stroke is the leading cause of adult disability. Even after discharge from rehabilitation, residual gait deficits are prevalent in stroke survivors, leading to decreased walking speed and endurance. Because gait dysfunctions limit community mobility, stroke survivors and rehabilitation clinicians consider restoration of walking a major goal of rehabilitation. Several challenges and research gaps limit the effectiveness of current clinical gait rehabilitation practices. While there is consensus that stroke survivors benefit from gait rehabilitation, agreement is lacking on which specific training interventions are most efficacious. The long-term goal of this proposal is to address these challenges by developing personalized, engaging, salient gait training treatments founded on evidence from neuroscience, biomechanics, motor learning, and gaming.

Real-time biofeedback is a promising gait training intervention for targeting specific biomechanical impairments. Biofeedback can enhance an individual's awareness of the impairment targeted during gait training, enabling self-correction of aberrant gait patterns.

In response to treadmill training combined with visual and auditory real-time biofeedback, able-bodied individuals can increase AGRF unilaterally for the targeted limb. Thus, AGRF biofeedback may be a beneficial strategy to target unilateral propulsive deficits in people post-stroke. Incorporation of gaming interfaces for gait biofeedback can increase patient motivation, distract participants from fatigue or boredom, and encourage greater numbers of repetitions during gait training.

The long-term goal of this study is to develop a more engaging, motivating gait biofeedback methodologies specifically designed for post-stroke gait training. The researchers aim to address a major challenge for rehabilitation clinicians - to make gait training appealing and meaningful so that patients engage in sufficient repetitions, intensity, and challenge to maximize therapeutic effectiveness. The study premise is that post-stroke individuals will demonstrate greater engagement, motivation, and therapeutic benefits during gait training sessions involving biofeedback when training incorporates intuitive, entertaining, game-based interfaces. Outcomes of the study will include measures of participant engagement, user-reports and survey-responses on motivation, fatigue, game characteristics, and adverse effects (e.g. nausea, dizziness) during game exposure. In addition to this clinical trial with stroke survivor participants, data about the game interface will be collected by having able-bodied neuro-rehabilitation clinicians try the 3 types of biofeedback interventions.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
12 post-stroke individuals will complete 3 different biofeedback interfaces in random order.
Masking: Single (Outcomes Assessor)
Masking Description:
The study outcomes will be collected by an evaluator (licensed physical therapist) who was not involved in study design and is blinded to the biofeedback assignment/order.
Primary Purpose: Treatment
Condition  ICMJE
  • Gait, Hemiplegic
  • Stroke
Intervention  ICMJE
  • Other: Game without AR
    During the AGRF biofeedback game without augmented reality (AR) participants will walk on a split-belt treadmill with a projector-display. Participants will be receiving real-time information or feedback about ongoing gait performance parameters while they are walking. The participants will be exposed to the AGRF biofeedback game without AR for 6 minutes.
    Other Name: gait training
  • Other: Game with AR
    During the AGRF biofeedback game with augmented reality (AR) participants will walk on a split-belt treadmill with a head-mounted AR display. Participants will be receiving real-time information or feedback about ongoing gait performance parameters while they are walking. The participants will be exposed to the AGRF biofeedback game with AR for 6 minutes.
    Other Name: gait training
  • Other: Traditional Biofeedback Interface
    For the traditional non-game biofeedback, the visual display comprises a horizontal line graph with a moveable cursor that represents the current measured value of antero-posterior ground reaction force for the targeted leg. The auditory feedback comprises an audible "beep" produced every time the cursor entered the target range. Participants will be exposed to the traditional biofeedback interface for 6 minutes.
    Other Name: gait training
Study Arms  ICMJE
  • Game without AR, Game with AR, Traditional Interface
    Post-stroke participants randomized to receive the three gait training biofeedback interfaces in the order of: game without AR, game with AR, traditional interface
    Interventions:
    • Other: Game without AR
    • Other: Game with AR
    • Other: Traditional Biofeedback Interface
  • Game without AR, Traditional Interface, Game with AR
    Post-stroke participants randomized to receive the three gait training biofeedback interfaces in the order of: game without AR, traditional interface, game with AR
    Interventions:
    • Other: Game without AR
    • Other: Game with AR
    • Other: Traditional Biofeedback Interface
  • Game with AR, Game without AR, Traditional Interface
    Post-stroke participants randomized to receive the three gait training biofeedback interfaces in the order of: game with AR, game without AR, traditional interface
    Interventions:
    • Other: Game without AR
    • Other: Game with AR
    • Other: Traditional Biofeedback Interface
  • Game with AR, Traditional Interface, Game without AR
    Post-stroke participants randomized to receive the three gait training biofeedback interfaces in the order of: game with AR, traditional interface, game without AR
    Interventions:
    • Other: Game without AR
    • Other: Game with AR
    • Other: Traditional Biofeedback Interface
  • Traditional Interface, Game without AR, Game with AR
    Post-stroke participants randomized to receive the three gait training biofeedback interfaces in the order of: traditional interface, game without AR, game with AR
    Interventions:
    • Other: Game without AR
    • Other: Game with AR
    • Other: Traditional Biofeedback Interface
  • Traditional Interface, Game with AR, Game without AR
    Post-stroke participants randomized to receive the three gait training biofeedback interfaces in the order of: traditional interface, game with AR, game without AR
    Interventions:
    • Other: Game without AR
    • Other: Game with AR
    • Other: Traditional Biofeedback Interface
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 8, 2019)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2021
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria for Post-Stroke Participants:

  • chronic stroke (>6 months post stroke)
  • ambulatory with or without the use of a cane or walker
  • able to walk for 2 minutes at the self-selected speed without an orthoses
  • resting heart rate 40-100 beats per minute

Exclusion Criteria for Post-Stroke Participants:

  • cerebellar signs (ataxic ("drunken") gait or decreased coordination during rapid alternating hand or foot movements
  • history of lower extremity joint replacement
  • inability to communicate with investigators
  • neglect/hemianopia, or unexplained dizziness in last 6 months
  • neurologic conditions other than stroke
  • orthopedic problems in the lower limbs or spine (or other medical conditions) that limit walking or cause pain during walking
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Trisha Kesar, PT, PhD 404-712-5803 tkesar@emory.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04013971
Other Study ID Numbers  ICMJE IRB00106866
1R21HD095138-01 ( U.S. NIH Grant/Contract )
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie results, after de-identification, will be available for sharing.
Time Frame: Individual participant data will be available for sharing beginning 9 months and ending 36 months after the article publication.
Access Criteria: Data will be available for sharing with investigators whose proposed used of the data has been approved by an independent review committee identified for this purpose. Data will be shared for the purposes of achieving the aims in the approved proposal. Proposals should be directed to trisha.m.kesar@emory.edu. To access the data, requestors will need to sign a data access agreement.
Responsible Party Trisha Kesar, PT, PhD, Emory University
Study Sponsor  ICMJE Emory University
Collaborators  ICMJE Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators  ICMJE
Principal Investigator: Trisha Kesar, PT, PhD Emory University
PRS Account Emory University
Verification Date April 2021

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