Trial Outcomes & Findings for Biofeedback to Increase Propulsion During Walking After Stroke (NCT NCT02667392)
NCT ID: NCT02667392
Last Updated: 2021-02-21
Results Overview
The propulsive impulse will be derived from the time integral of the positive anterior-posterior ground reaction force for the paretic leg normalized to Body Weight.
COMPLETED
PHASE1
11 participants
Pre-intervention (prior to 1st intervention session) and Post-intervention (after the final (12th intervention session), approximately 4 weeks after entering the study.
2021-02-21
Participant Flow
Participants were enrolled between October 2017 and August 2019. Study site was the Brain Rehabilitation Research Center at the Malcom Randall Veterans Affairs Medical Center - akin to an "outpatient" site.
The original study design was to have two arms: 1) Biofeedback arm, 2) Verbal feedback arm. Secondary to construction of the laboratory space where the study was to take place and delayed human resources hiring of study personnel, recruitment for this study was delayed. It was determined that the most prudent course of action would be to conduct a single-arm study with all participants being assigned to the biofeedback arm.
Participant milestones
| Measure |
Biofeedback Group
Participants will wear a pressure-sensitive insole inside the shoe of their paretic limb. An auditory tone will sound when participants have provided sufficient load to active the pressure-sensitive in-sole.
Gait Training with Biofeedback: Intervention (12, 60-minute sessions, 3 times/week for four weeks) will occur in an outpatient research setting. Participants will be supervised by a licensed physical therapist and wear a gait belt during all activities. The therapist will choose from a standardized bank of gait activities, suitable to each participant's ability level. The goal for total walking time for each session will be 50 minutes: 5, 10-minute bouts with a 2-minute rest between bouts. This is the typical length and intensity of outpatient rehabilitation sessions for ambulatory patients discharged from inpatient rehabilitation.
Biofeedback Group: Biofeedback (external-focus feedback) will be provided as an adjuvant to therapist-provided feedback during the intervention. Participants will be instructed that a tone will sound when they "push off with their (paretic) leg to swing it forward" when the participant-specific pre-programmed threshold is exceeded.
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Overall Study
STARTED
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11
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Overall Study
COMPLETED
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11
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Biofeedback to Increase Propulsion During Walking After Stroke
Baseline characteristics by cohort
| Measure |
Biofeedback Group
n=11 Participants
Participants will wear a pressure-sensitive insole inside the shoe of their paretic limb. An auditory tone will sound when participants have provided sufficient load to active the pressure-sensitive in-sole.
Gait Training with Biofeedback: Intervention (12, 60-minute sessions, 3 times/week for four weeks) will occur in an outpatient research setting. Participants will be supervised by a licensed physical therapist and wear a gait belt during all activities. The therapist will choose from a standardized bank of gait activities, suitable to each participant's ability level. The goal for total walking time for each session will be 50 minutes: 5, 10-minute bouts with a 2-minute rest between bouts. This is the typical length and intensity of outpatient rehabilitation sessions for ambulatory patients discharged from inpatient rehabilitation.
Biofeedback Group: Biofeedback (external-focus feedback) will be provided as an adjuvant to therapist-provided feedback during the intervention. Participants will be instructed that a tone will sound when they "push off with their (paretic) leg to swing it forward" when the participant-specific pre-programmed threshold is exceeded.
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Age, Continuous
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59.0 years
STANDARD_DEVIATION 8.1 • n=5 Participants
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Sex: Female, Male
Female
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5 Participants
n=5 Participants
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Sex: Female, Male
Male
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6 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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1 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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4 Participants
n=5 Participants
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Race (NIH/OMB)
White
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6 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Time Since Stroke Onset
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40.4 months
STANDARD_DEVIATION 29.1 • n=5 Participants
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PRIMARY outcome
Timeframe: Pre-intervention (prior to 1st intervention session) and Post-intervention (after the final (12th intervention session), approximately 4 weeks after entering the study.Population: The original study design was to have two arms: 1) Biofeedback arm, 2) Verbal feedback arm. Secondary to construction of the laboratory space where the study was to take place and delayed human resources hiring of study personnel, recruitment for this study was delayed. It was determined that the most prudent course of action to study the efficacy of this experimental biofeedback intervention would be to conduct a single-arm study with all participants being assigned to the biofeedback arm.
The propulsive impulse will be derived from the time integral of the positive anterior-posterior ground reaction force for the paretic leg normalized to Body Weight.
Outcome measures
| Measure |
Biofeedback Group
n=11 Participants
Participants will wear a pressure-sensitive insole inside the shoe of their paretic limb. An auditory tone will sound when participants have provided sufficient load to active the pressure-sensitive in-sole.
Gait Training with Biofeedback: Intervention (12, 60-minute sessions, 3 times/week for four weeks) will occur in an outpatient research setting. Participants will be supervised by a licensed physical therapist and wear a gait belt during all activities. The therapist will choose from a standardized bank of gait activities, suitable to each participant's ability level. The goal for total walking time for each session will be 50 minutes: 5, 10-minute bouts with a 2-minute rest between bouts. This is the typical length and intensity of outpatient rehabilitation sessions for ambulatory patients discharged from inpatient rehabilitation.
Biofeedback Group: Biofeedback (external-focus feedback) will be provided as an adjuvant to therapist-provided feedback during the intervention. Participants will be instructed that a tone will sound when they "push off with their (paretic) leg to swing it forward" when the participant-specific pre-programmed threshold is exceeded.
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Change From Baseline in Forward Propulsion of the Paretic Limb From Pre- to Post-intervention
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0.00 Newtons . seconds/Body Weight
Standard Error .017
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SECONDARY outcome
Timeframe: Pre-intervention (prior to 1st intervention session) and Post-intervention (after the final (12th intervention session), approximately 4 weeks after entering the study.Population: The original study design was to have two arms: 1) Biofeedback arm, 2) Verbal feedback arm. Secondary to construction of the laboratory space where the study was to take place and delayed human resources hiring of study personnel, recruitment for this study was delayed. It was determined that the most prudent course of action to study the efficacy of this experimental biofeedback intervention would be to conduct a single-arm study with all participants being assigned to the biofeedback arm.
Hip motion data will be acquired using a modified Helen Hayes marker set with rigid clusters on the pelvis and each thigh and reflective markers at the greater trochanter and the lateral condyle of the femur. The angle formed between the rigid cluster on the pelvis and the lateral condyle of the femur will be recorded at 100 Hz using a 12 camera motion capture system. The peak value from 10 gait cycles was averaged to obtain an average peak value.
Outcome measures
| Measure |
Biofeedback Group
n=11 Participants
Participants will wear a pressure-sensitive insole inside the shoe of their paretic limb. An auditory tone will sound when participants have provided sufficient load to active the pressure-sensitive in-sole.
Gait Training with Biofeedback: Intervention (12, 60-minute sessions, 3 times/week for four weeks) will occur in an outpatient research setting. Participants will be supervised by a licensed physical therapist and wear a gait belt during all activities. The therapist will choose from a standardized bank of gait activities, suitable to each participant's ability level. The goal for total walking time for each session will be 50 minutes: 5, 10-minute bouts with a 2-minute rest between bouts. This is the typical length and intensity of outpatient rehabilitation sessions for ambulatory patients discharged from inpatient rehabilitation.
Biofeedback Group: Biofeedback (external-focus feedback) will be provided as an adjuvant to therapist-provided feedback during the intervention. Participants will be instructed that a tone will sound when they "push off with their (paretic) leg to swing it forward" when the participant-specific pre-programmed threshold is exceeded.
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Change From Baseline in Peak Hip Flexion Range of Motion, in Degrees, of the Paretic Leg From Pre- to Post-intervention
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1.5 degrees
Standard Error 2.9
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SECONDARY outcome
Timeframe: Pre-intervention (prior to 1st intervention session) and Post-intervention (after the final (12th intervention session), approximately 4 weeks after entering the study.Population: The original study design was to have two arms: 1) Biofeedback arm, 2) Verbal feedback arm. Secondary to construction of the laboratory space where the study was to take place and delayed human resources hiring of study personnel, recruitment for this study was delayed. It was determined that the most prudent course of action to study the efficacy of this experimental biofeedback intervention would be to conduct a single-arm study with all participants being assigned to the biofeedback arm.
Data will be acquired while walking across a GAITRite instrumented walkway.
Outcome measures
| Measure |
Biofeedback Group
n=11 Participants
Participants will wear a pressure-sensitive insole inside the shoe of their paretic limb. An auditory tone will sound when participants have provided sufficient load to active the pressure-sensitive in-sole.
Gait Training with Biofeedback: Intervention (12, 60-minute sessions, 3 times/week for four weeks) will occur in an outpatient research setting. Participants will be supervised by a licensed physical therapist and wear a gait belt during all activities. The therapist will choose from a standardized bank of gait activities, suitable to each participant's ability level. The goal for total walking time for each session will be 50 minutes: 5, 10-minute bouts with a 2-minute rest between bouts. This is the typical length and intensity of outpatient rehabilitation sessions for ambulatory patients discharged from inpatient rehabilitation.
Biofeedback Group: Biofeedback (external-focus feedback) will be provided as an adjuvant to therapist-provided feedback during the intervention. Participants will be instructed that a tone will sound when they "push off with their (paretic) leg to swing it forward" when the participant-specific pre-programmed threshold is exceeded.
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|---|---|
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Change From Baseline in Stride Time From Pre to Post-intervention.
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0.1 Seconds
Standard Error 0
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SECONDARY outcome
Timeframe: Pre-intervention (prior to 1st intervention session) and Post-intervention (after the final (12th intervention session), approximately 4 weeks after entering the study.Population: The original study design was to have two arms: 1) Biofeedback arm, 2) Verbal feedback arm. Secondary to construction of the laboratory space where the study was to take place and delayed human resources hiring of study personnel, recruitment for this study was delayed. It was determined that the most prudent course of action to study the efficacy of this experimental biofeedback intervention would be to conduct a single-arm study with all participants being assigned to the biofeedback arm.
Participants will walk for a total of six minutes at their comfortable walking speed and the total distance will be recorded.
Outcome measures
| Measure |
Biofeedback Group
n=11 Participants
Participants will wear a pressure-sensitive insole inside the shoe of their paretic limb. An auditory tone will sound when participants have provided sufficient load to active the pressure-sensitive in-sole.
Gait Training with Biofeedback: Intervention (12, 60-minute sessions, 3 times/week for four weeks) will occur in an outpatient research setting. Participants will be supervised by a licensed physical therapist and wear a gait belt during all activities. The therapist will choose from a standardized bank of gait activities, suitable to each participant's ability level. The goal for total walking time for each session will be 50 minutes: 5, 10-minute bouts with a 2-minute rest between bouts. This is the typical length and intensity of outpatient rehabilitation sessions for ambulatory patients discharged from inpatient rehabilitation.
Biofeedback Group: Biofeedback (external-focus feedback) will be provided as an adjuvant to therapist-provided feedback during the intervention. Participants will be instructed that a tone will sound when they "push off with their (paretic) leg to swing it forward" when the participant-specific pre-programmed threshold is exceeded.
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|---|---|
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Change From Baseline in Distance Covered During the Six Minute Walk Test From Pre- to Post-intervention
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44 Meters
Standard Error 11.4
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SECONDARY outcome
Timeframe: Pre-intervention (prior to 1st intervention session) and Post-intervention (after the final (12th intervention session), approximately 4 weeks after entering the study.Population: The original study design was to have two arms: 1) Biofeedback arm, 2) Verbal feedback arm. Secondary to construction of the laboratory space where the study was to take place and delayed human resources hiring of study personnel, recruitment for this study was delayed. It was determined that the most prudent course of action to study the efficacy of this experimental biofeedback intervention would be to conduct a single-arm study with all participants being assigned to the biofeedback arm.
Ten item gait and balance test during which participants walk forwards, backwards, ascend/descend stairs, walk with head turning and step over obstacles. Score ranges from 0-30 with a larger number indicative of a better outcome. Each item is scored on a 0-4 scale with a lower number representing greater impairment. The individual score on each of the ten items are summed for a total score with a larger number indicative of a better outcome.
Outcome measures
| Measure |
Biofeedback Group
n=11 Participants
Participants will wear a pressure-sensitive insole inside the shoe of their paretic limb. An auditory tone will sound when participants have provided sufficient load to active the pressure-sensitive in-sole.
Gait Training with Biofeedback: Intervention (12, 60-minute sessions, 3 times/week for four weeks) will occur in an outpatient research setting. Participants will be supervised by a licensed physical therapist and wear a gait belt during all activities. The therapist will choose from a standardized bank of gait activities, suitable to each participant's ability level. The goal for total walking time for each session will be 50 minutes: 5, 10-minute bouts with a 2-minute rest between bouts. This is the typical length and intensity of outpatient rehabilitation sessions for ambulatory patients discharged from inpatient rehabilitation.
Biofeedback Group: Biofeedback (external-focus feedback) will be provided as an adjuvant to therapist-provided feedback during the intervention. Participants will be instructed that a tone will sound when they "push off with their (paretic) leg to swing it forward" when the participant-specific pre-programmed threshold is exceeded.
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|---|---|
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Change From Baseline in the Functional Gait Assessment Score From Pre- to Post-intervention
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2.1 score on a scale
Standard Error 0.8
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SECONDARY outcome
Timeframe: Pre-intervention (prior to 1st intervention session) and Post-intervention (after the final (12th intervention session), approximately 4 weeks after entering the study.Population: The original study design was to have two arms: 1) Biofeedback arm, 2) Verbal feedback arm. Secondary to construction of the laboratory space where the study was to take place and delayed human resources hiring of study personnel, recruitment for this study was delayed. It was determined that the most prudent course of action to study the efficacy of this experimental biofeedback intervention would be to conduct a single-arm study with all participants being assigned to the biofeedback arm.
Fourteen item questionnaire designed to measure self-perceived fear of falling during task performance. Score range is between 0-10 with a higher score indicative of a better outcome
Outcome measures
| Measure |
Biofeedback Group
n=11 Participants
Participants will wear a pressure-sensitive insole inside the shoe of their paretic limb. An auditory tone will sound when participants have provided sufficient load to active the pressure-sensitive in-sole.
Gait Training with Biofeedback: Intervention (12, 60-minute sessions, 3 times/week for four weeks) will occur in an outpatient research setting. Participants will be supervised by a licensed physical therapist and wear a gait belt during all activities. The therapist will choose from a standardized bank of gait activities, suitable to each participant's ability level. The goal for total walking time for each session will be 50 minutes: 5, 10-minute bouts with a 2-minute rest between bouts. This is the typical length and intensity of outpatient rehabilitation sessions for ambulatory patients discharged from inpatient rehabilitation.
Biofeedback Group: Biofeedback (external-focus feedback) will be provided as an adjuvant to therapist-provided feedback during the intervention. Participants will be instructed that a tone will sound when they "push off with their (paretic) leg to swing it forward" when the participant-specific pre-programmed threshold is exceeded.
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Change From Baseline in the Modified Falls Efficacy Scale From Pre- to Post-intervention
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0.8 score on a scale
Standard Error 0.4
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SECONDARY outcome
Timeframe: Pre-intervention (prior to 1st intervention session) and Post-intervention (after the final (12th intervention session), approximately 4 weeks after entering the study.Population: The original study design was to have two arms: 1) Biofeedback arm, 2) Verbal feedback arm. Secondary to construction of the laboratory space where the study was to take place and delayed human resources hiring of study personnel, recruitment for this study was delayed. It was determined that the most prudent course of action to study the efficacy of this experimental biofeedback intervention would be to conduct a single-arm study with all participants being assigned to the biofeedback arm.
Footfall of both limbs will be acquired while participants walk across a pressure sensitive instrumented walkway (GAITRite). From these footballs paretic step time will be calculated.
Outcome measures
| Measure |
Biofeedback Group
n=11 Participants
Participants will wear a pressure-sensitive insole inside the shoe of their paretic limb. An auditory tone will sound when participants have provided sufficient load to active the pressure-sensitive in-sole.
Gait Training with Biofeedback: Intervention (12, 60-minute sessions, 3 times/week for four weeks) will occur in an outpatient research setting. Participants will be supervised by a licensed physical therapist and wear a gait belt during all activities. The therapist will choose from a standardized bank of gait activities, suitable to each participant's ability level. The goal for total walking time for each session will be 50 minutes: 5, 10-minute bouts with a 2-minute rest between bouts. This is the typical length and intensity of outpatient rehabilitation sessions for ambulatory patients discharged from inpatient rehabilitation.
Biofeedback Group: Biofeedback (external-focus feedback) will be provided as an adjuvant to therapist-provided feedback during the intervention. Participants will be instructed that a tone will sound when they "push off with their (paretic) leg to swing it forward" when the participant-specific pre-programmed threshold is exceeded.
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|---|---|
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Change From Baseline in Paretic Limb Step Time From Pre- to Post-intervention.
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.04 Seconds
Standard Error .07
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SECONDARY outcome
Timeframe: Pre-intervention (prior to 1st intervention session) and Post-intervention (after the final (12th intervention session), approximately 4 weeks after entering the study.Population: The original study design was to have two arms: 1) Biofeedback arm, 2) Verbal feedback arm. Secondary to construction of the laboratory space where the study was to take place and delayed human resources hiring of study personnel, recruitment for this study was delayed. It was determined that the most prudent course of action to study the efficacy of this experimental biofeedback intervention would be to conduct a single-arm study with all participants being assigned to the biofeedback arm.
Footfalls from both limbs will be acquired as participant walks across a pressure-sensitive instrumented walkway (GAITRite). From these footfalls will be used to calculate paretic limb stride length.
Outcome measures
| Measure |
Biofeedback Group
n=11 Participants
Participants will wear a pressure-sensitive insole inside the shoe of their paretic limb. An auditory tone will sound when participants have provided sufficient load to active the pressure-sensitive in-sole.
Gait Training with Biofeedback: Intervention (12, 60-minute sessions, 3 times/week for four weeks) will occur in an outpatient research setting. Participants will be supervised by a licensed physical therapist and wear a gait belt during all activities. The therapist will choose from a standardized bank of gait activities, suitable to each participant's ability level. The goal for total walking time for each session will be 50 minutes: 5, 10-minute bouts with a 2-minute rest between bouts. This is the typical length and intensity of outpatient rehabilitation sessions for ambulatory patients discharged from inpatient rehabilitation.
Biofeedback Group: Biofeedback (external-focus feedback) will be provided as an adjuvant to therapist-provided feedback during the intervention. Participants will be instructed that a tone will sound when they "push off with their (paretic) leg to swing it forward" when the participant-specific pre-programmed threshold is exceeded.
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|---|---|
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Change From Baseline in Paretic Limb Stride Length From Pre to Post-intervention.
|
.05 Meters
Standard Error .02
|
SECONDARY outcome
Timeframe: Pre-intervention (prior to 1st intervention session) and Post-intervention (after the final (12th intervention session), approximately 4 weeks after entering the study.Population: The original study design was to have two arms: 1) Biofeedback arm, 2) Verbal feedback arm. Secondary to construction of the laboratory space where the study was to take place and delayed human resources hiring of study personnel, recruitment for this study was delayed. It was determined that the most prudent course of action to study the efficacy of this experimental biofeedback intervention would be to conduct a single-arm study with all participants being assigned to the biofeedback arm.
Footfalls from both limbs will be acquired as participant walks across a pressure-sensitive instrumented walkway (GAITRite). From these footfalls will be used to calculate paretic limb step length.
Outcome measures
| Measure |
Biofeedback Group
n=11 Participants
Participants will wear a pressure-sensitive insole inside the shoe of their paretic limb. An auditory tone will sound when participants have provided sufficient load to active the pressure-sensitive in-sole.
Gait Training with Biofeedback: Intervention (12, 60-minute sessions, 3 times/week for four weeks) will occur in an outpatient research setting. Participants will be supervised by a licensed physical therapist and wear a gait belt during all activities. The therapist will choose from a standardized bank of gait activities, suitable to each participant's ability level. The goal for total walking time for each session will be 50 minutes: 5, 10-minute bouts with a 2-minute rest between bouts. This is the typical length and intensity of outpatient rehabilitation sessions for ambulatory patients discharged from inpatient rehabilitation.
Biofeedback Group: Biofeedback (external-focus feedback) will be provided as an adjuvant to therapist-provided feedback during the intervention. Participants will be instructed that a tone will sound when they "push off with their (paretic) leg to swing it forward" when the participant-specific pre-programmed threshold is exceeded.
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|---|---|
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Change From Baseline in Paretic Limb Step Length From Pre to Post-intervention.
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.01 Meters
Standard Error .02
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SECONDARY outcome
Timeframe: Pre-intervention (prior to 1st intervention session) and Post-intervention (after the final (12th intervention session), approximately 4 weeks after entering the study.Population: The original study design was to have two arms: 1) Biofeedback arm, 2) Verbal feedback arm. Secondary to construction of the laboratory space where the study was to take place and delayed human resources hiring of study personnel, recruitment for this study was delayed. It was determined that the most prudent course of action to study the efficacy of this experimental biofeedback intervention would be to conduct a single-arm study with all participants being assigned to the biofeedback arm.
Footfalls from both limbs will be acquired as participant walks across a pressure-sensitive instrumented walkway (GAITRite). From these footfalls will be used to calculate paretic limb step width.
Outcome measures
| Measure |
Biofeedback Group
n=11 Participants
Participants will wear a pressure-sensitive insole inside the shoe of their paretic limb. An auditory tone will sound when participants have provided sufficient load to active the pressure-sensitive in-sole.
Gait Training with Biofeedback: Intervention (12, 60-minute sessions, 3 times/week for four weeks) will occur in an outpatient research setting. Participants will be supervised by a licensed physical therapist and wear a gait belt during all activities. The therapist will choose from a standardized bank of gait activities, suitable to each participant's ability level. The goal for total walking time for each session will be 50 minutes: 5, 10-minute bouts with a 2-minute rest between bouts. This is the typical length and intensity of outpatient rehabilitation sessions for ambulatory patients discharged from inpatient rehabilitation.
Biofeedback Group: Biofeedback (external-focus feedback) will be provided as an adjuvant to therapist-provided feedback during the intervention. Participants will be instructed that a tone will sound when they "push off with their (paretic) leg to swing it forward" when the participant-specific pre-programmed threshold is exceeded.
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|---|---|
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Change From Baseline in Paretic Limb Step Width From Pre to Post-intervention.
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0.0 Meters
Standard Error 0.0
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SECONDARY outcome
Timeframe: Pre-intervention (prior to 1st intervention session) and Post-intervention (after the final (12th intervention session), approximately 4 weeks after entering the study.Population: The original study design was to have two arms: 1) Biofeedback arm, 2) Verbal feedback arm. Secondary to construction of the laboratory space where the study was to take place and delayed human resources hiring of study personnel, recruitment for this study was delayed. It was determined that the most prudent course of action to study the efficacy of this experimental biofeedback intervention would be to conduct a single-arm study with all participants being assigned to the biofeedback arm.
Data will be acquired while participants walk across a pressure-sensitive 14 meter instrumented walkway (Brand Name: GAITRite).
Outcome measures
| Measure |
Biofeedback Group
n=11 Participants
Participants will wear a pressure-sensitive insole inside the shoe of their paretic limb. An auditory tone will sound when participants have provided sufficient load to active the pressure-sensitive in-sole.
Gait Training with Biofeedback: Intervention (12, 60-minute sessions, 3 times/week for four weeks) will occur in an outpatient research setting. Participants will be supervised by a licensed physical therapist and wear a gait belt during all activities. The therapist will choose from a standardized bank of gait activities, suitable to each participant's ability level. The goal for total walking time for each session will be 50 minutes: 5, 10-minute bouts with a 2-minute rest between bouts. This is the typical length and intensity of outpatient rehabilitation sessions for ambulatory patients discharged from inpatient rehabilitation.
Biofeedback Group: Biofeedback (external-focus feedback) will be provided as an adjuvant to therapist-provided feedback during the intervention. Participants will be instructed that a tone will sound when they "push off with their (paretic) leg to swing it forward" when the participant-specific pre-programmed threshold is exceeded.
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|---|---|
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Change From Baseline in Gait Speed From Pre to Post-intervention.
|
0.14 meters/second
Standard Error .07
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Adverse Events
Biofeedback Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place