Focus of Attention in Individuals With Stroke
Primary Purpose
Cerebrovascular Accident
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Focus of attention
Sponsored by

About this trial
This is an interventional treatment trial for Cerebrovascular Accident focused on measuring Focus of attention, Motor learning, Seated weight shifting
Eligibility Criteria
Inclusion Criteria:
- participants with history of stroke
- ability to sit statically without physical assistance
Exclusion Criteria:
- severe hemineglect (star cancellation test <44/54)
- inability to follow multistep commands
- orthopedic issues that limited their ability to weight shift including severe hip or back pain
- individuals with other neurologic conditions such as dementia
- individuals with contraversive pushing.
During the first arm (phase) of the study there were age matched healthy controls.
Sites / Locations
- Western Carolina University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Focus of attention in individuals post chronic stroke during seated lateral weight shifting
Focus of attention in individuals post acute stroke during seated lateral weight shifting
Arm Description
Feasibility study
Feasibility study
Outcomes
Primary Outcome Measures
Recruitment
Percentage of participants recruited out of the estimated number needed by power analysis. Power analyses revealed 42 participants were needed for 2X4 mixed model ANOVA 193 analysis, a=.05, power=.8, with a medium effect size, f=.2.
Retention
Percentage of participants that completed all 4 timepoints, baseline, acquisition, short term, and long term retention out of those that completed baseline trials.
Secondary Outcome Measures
Shoulder alignment during baseline to affected side
Only used in arm 2 of the study. Angle measuring a line from acromion to acromion compared to a horizontal plumb line. This is a repeated measure over 4 time points. This measurement will occur during each lateral weight shift for all participants. Pt's will shift to either side 3 times during baseline, short term and long term retention. Participants shifted to both sides 6 times to each side during arm 2 of the study. Averages were used for data analysis.
A 9.5" X 7.31" X 0.37" 4th generation iPad†, with a 9.7-inch retina display, was used to record videos of each trial. The iPad has a 1080p HD video and 1.2 MP photo camera with autofocus and a 2.4 aperture with video stabilization. From this footage, shoulder alignment was measured during seated lateral weight shifting using the Body Align Pro app‡, trademarked on Nov. 28, 2014.
Shoulder alignment during baseline to unaffected side
Only used in arm 2 of the study. Angle measuring a line from acromion to acromion compared to a horizontal plumb line. This is a repeated measure over 4 time points. This measurement will occur during each lateral weight shift for all participants. Pt's will shift to either side 3 times during baseline, short term and long term retention. Participants shifted to both sides 6 times to each side during arm 2 of the study. Averages were used for data analysis.
A 9.5" X 7.31" X 0.37" 4th generation iPad†, with a 9.7-inch retina display, was used to record videos of each trial. The iPad has a 1080p HD video and 1.2 MP photo camera with autofocus and a 2.4 aperture with video stabilization. From this footage, shoulder alignment was measured during seated lateral weight shifting using the Body Align Pro app‡, trademarked on Nov. 28, 2014.
Shoulder alignment during acquisition or training to affected side
Arm 2 only. Angle measuring a line from acromion to acromion compared to a horizontal plumb line. This is a repeated measure over 4 time points. This measurement will occur during each lateral weight shift for all participants. Pt's will shift to either side 3 times during baseline, short term and long term retention. Participants shifted to both sides 6 times to each side during arm 2 of the study. Averages were used for data analysis.Baseline measurements are taken, then participants are given a 2 minute demonstration of what to do during training. The training or acquisition occurs right afterwards.A 9.5" X 7.31" X 0.37" 4th generation iPad†, with a 9.7-inch retina display, was used to record videos of each trial. The iPad has a 1080p HD video and 1.2 MP photo camera with autofocus and a 2.4 aperture with video stabilization. From this footage, shoulder alignment was measured during seated lateral weight shifting using the Body Align Pro app‡, trademarked on Nov. 28, 2014.
Shoulder alignment during acquisition or training to unaffected side
Arm 2 only. Angle measuring a line from acromion to acromion compared to a horizontal plumb line. This is a repeated measure over 4 time points. This measurement will occur during each lateral weight shift for all participants. Pt's will shift to either side 3 times during baseline, short term and long term retention. Participants shifted to both sides 6 times to each side during arm 2 of the study. Averages were used for data analysis. Baseline measurements are taken, then participants are given a 2 minute demonstration of what to do during training. The training or acquisition occurs right afterwards. A 9.5" X 7.31" X 0.37" 4th generation iPad†, with a 9.7-inch retina display, was used to record videos of each trial. The iPad has a 1080p HD video and 1.2 MP photo camera with autofocus and a 2.4 aperture with video stabilization. From this footage, shoulder alignment was measured during seated lateral weight shifting using the Body Align Pro app‡, trademarked on Nov. 28, 2014.
Shoulder alignment during short term retention to affected side
Only used in arm 2 of the study. Angle measuring a line from acromion to acromion compared to a horizontal plumb line. This is a repeated measure over 4 time points. This measurement will occur during each lateral weight shift for all participants. Pt's will shift to either side 3 times during baseline, short term and long term retention. Participants shifted to both sides 6 times to each side during arm 2 of the study. Averages were used for data analysis.
A 9.5" X 7.31" X 0.37" 4th generation iPad†, with a 9.7-inch retina display, was used to record videos of each trial. The iPad has a 1080p HD video and 1.2 MP photo camera with autofocus and a 2.4 aperture with video stabilization. From this footage, shoulder alignment was measured during seated lateral weight shifting using the Body Align Pro app‡, trademarked on Nov. 28, 2014.
Shoulder alignment during short term retention to unaffected side
Only used in arm 2 of the study. Angle measuring a line from acromion to acromion compared to a horizontal plumb line. This is a repeated measure over 4 time points. This measurement will occur during each lateral weight shift for all participants. Pt's will shift to either side 3 times during baseline, short term and long term retention. Participants shifted to both sides 6 times to each side during arm 2 of the study. Averages were used for data analysis.
A 9.5" X 7.31" X 0.37" 4th generation iPad†, with a 9.7-inch retina display, was used to record videos of each trial. The iPad has a 1080p HD video and 1.2 MP photo camera with autofocus and a 2.4 aperture with video stabilization. From this footage, shoulder alignment was measured during seated lateral weight shifting using the Body Align Pro app‡, trademarked on Nov. 28, 2014.
Shoulder alignment during long term retention to affected side
Only used in arm 2 of the study. Angle measuring a line from acromion to acromion compared to a horizontal plumb line. This is a repeated measure over 4 time points. This measurement will occur during each lateral weight shift for all participants. Pt's will shift to either side 3 times during baseline, short term and long term retention. Participants shifted to both sides 6 times to each side during arm 2 of the study. Averages were used for data analysis.
A 9.5" X 7.31" X 0.37" 4th generation iPad†, with a 9.7-inch retina display, was used to record videos of each trial. The iPad has a 1080p HD video and 1.2 MP photo camera with autofocus and a 2.4 aperture with video stabilization. From this footage, shoulder alignment was measured during seated lateral weight shifting using the Body Align Pro app‡, trademarked on Nov. 28, 2014.
Shoulder alignment during long term retention to unaffected side
Only used in arm 2 of the study. Angle measuring a line from acromion to acromion compared to a horizontal plumb line. This is a repeated measure over 4 time points. This measurement will occur during each lateral weight shift for all participants. Pt's will shift to either side 3 times during baseline, short term and long term retention. Participants shifted to both sides 6 times to each side during arm 2 of the study. Averages were used for data analysis.
A 9.5" X 7.31" X 0.37" 4th generation iPad†, with a 9.7-inch retina display, was used to record videos of each trial. The iPad has a 1080p HD video and 1.2 MP photo camera with autofocus and a 2.4 aperture with video stabilization. From this footage, shoulder alignment was measured during seated lateral weight shifting using the Body Align Pro app‡, trademarked on Nov. 28, 2014.
Seated lateral excursion during baseline to affected side
Measure of how far individuals shifted their center of pressure laterally during each weight shift trial (cm). This is a repeated measure over 4 time points. This measurement will occur during each lateral weight shift for all participants. Pt's will shift to either side 3 times during baseline, short term and long term retention. In arm 1 participants shifted to both sides 3 times during the acquisition trials and 6 times to each side during arm 2 of the study.
A 32X32 array BodiTrak* pressure mat with an 18.125 in x 18.125 in sensing area (1,024 sensors) was used to measure lateral excursion of center of pressure during each trial for both phases. The pressure mat has a 200 mmHg calibration range and up to 150 Hz sampling frame rate.
Seated lateral excursion during baseline to unaffected side
Measure of how far individuals shifted their center of pressure laterally during each weight shift trial (cm). This is a repeated measure over 4 time points. This measurement will occur during each lateral weight shift for all participants. Pt's will shift to either side 3 times during baseline, short term and long term retention. In arm 1 participants shifted to both sides 3 times during the acquisition trials and 6 times to each side during arm 2 of the study.
A 32X32 array BodiTrak* pressure mat with an 18.125 in x 18.125 in sensing area (1,024 sensors) was used to measure lateral excursion of center of pressure during each trial for both phases. The pressure mat has a 200 mmHg calibration range and up to 150 Hz sampling frame rate.
Seated lateral excursion during acquisition or training to affected side
Measure of how far individuals shifted their center of pressure laterally during each weight shift trial (cm). This is a repeated measure over 4 time points. This measurement will occur during each lateral weight shift for all participants. Pt's will shift to either side 3 times during baseline, short term and long term retention. In arm 1 participants shifted to both sides 3 times during the acquisition trials and 6 times to each side during arm 2 of the study. Baseline measurements are taken, then participants are given a 2 minute demonstration of what to do during training. The training or acquisition occurs right after this demonstration and occurs for 30 minutes.
A 32X32 array BodiTrak* pressure mat with an 18.125 in x 18.125 in sensing area (1,024 sensors) was used to measure lateral excursion of center of pressure during each trial for both phases. The pressure mat has a 200 mmHg calibration range and up to 150 Hz sampling frame rate.
Seated lateral excursion during acquisition or training to unaffected side
Measure of how far individuals shifted their center of pressure laterally during each weight shift trial (cm). This is a repeated measure over 4 time points. This measurement will occur during each lateral weight shift for all participants. Pt's will shift to either side 3 times during baseline, short term and long term retention. In arm 1 participants shifted to both sides 3 times during the acquisition trials and 6 times to each side during arm 2 of the study. Baseline measurements are taken, then participants are given a 2 minute demonstration of what to do during training. The training or acquisition occurs right after this demonstration and occurs for 30 minutes.
A 32X32 array BodiTrak* pressure mat with an 18.125 in x 18.125 in sensing area (1,024 sensors) was used to measure lateral excursion of center of pressure during each trial for both phases. The pressure mat has a 200 mmHg calibration range and up to 150 Hz sampling frame rate.
Seated lateral excursion during short-term retention to affected side
Measure of how far individuals shifted their center of pressure laterally during each weight shift trial (cm). This is a repeated measure over 4 time points. This measurement will occur during each lateral weight shift for all participants. Pt's will shift to either side 3 times during baseline, short term and long term retention. In arm 1 participants shifted to both sides 3 times during the acquisition trials and 6 times to each side during arm 2 of the study.
A 32X32 array BodiTrak* pressure mat with an 18.125 in x 18.125 in sensing area (1,024 sensors) was used to measure lateral excursion of center of pressure during each trial for both phases. The pressure mat has a 200 mmHg calibration range and up to 150 Hz sampling frame rate.
Seated lateral excursion during short-term retention to unaffected side
Measure of how far individuals shifted their center of pressure laterally during each weight shift trial (cm). This is a repeated measure over 4 time points. This measurement will occur during each lateral weight shift for all participants. Pt's will shift to either side 3 times during baseline, short term and long term retention. In arm 1 participants shifted to both sides 3 times during the acquisition trials and 6 times to each side during arm 2 of the study.
A 32X32 array BodiTrak* pressure mat with an 18.125 in x 18.125 in sensing area (1,024 sensors) was used to measure lateral excursion of center of pressure during each trial for both phases. The pressure mat has a 200 mmHg calibration range and up to 150 Hz sampling frame rate.
Seated lateral excursion during long-term retention to affected side
Measure of how far individuals shifted their center of pressure laterally during each weight shift trial (cm). This is a repeated measure over 4 time points. This measurement will occur during each lateral weight shift for all participants. Pt's will shift to either side 3 times during baseline, short term and long term retention. In arm 1 participants shifted to both sides 3 times during the acquisition trials and 6 times to each side during arm 2 of the study.
A 32X32 array BodiTrak* pressure mat with an 18.125 in x 18.125 in sensing area (1,024 sensors) was used to measure lateral excursion of center of pressure during each trial for both phases. The pressure mat has a 200 mmHg calibration range and up to 150 Hz sampling frame rate.
Seated lateral excursion during long-term retention to unaffected side
Measure of how far individuals shifted their center of pressure laterally during each weight shift trial (cm). This is a repeated measure over 4 time points. This measurement will occur during each lateral weight shift for all participants. Pt's will shift to either side 3 times during baseline, short term and long term retention. In arm 1 participants shifted to both sides 3 times during the acquisition trials and 6 times to each side during arm 2 of the study.
A 32X32 array BodiTrak* pressure mat with an 18.125 in x 18.125 in sensing area (1,024 sensors) was used to measure lateral excursion of center of pressure during each trial for both phases. The pressure mat has a 200 mmHg calibration range and up to 150 Hz sampling frame rate.
Full Information
NCT ID
NCT04696302
First Posted
December 16, 2020
Last Updated
January 3, 2021
Sponsor
Western Carolina University
Collaborators
Mission Health System, Asheville, NC
1. Study Identification
Unique Protocol Identification Number
NCT04696302
Brief Title
Focus of Attention in Individuals With Stroke
Official Title
Focus of Attention Effects on Motor Performance and Learning in Individuals Post Stroke During Seated Lateral Weight Shifting: A Two-phase Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
March 23, 2015 (Actual)
Primary Completion Date
May 1, 2019 (Actual)
Study Completion Date
May 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western Carolina University
Collaborators
Mission Health System, Asheville, NC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This two phase feasibility study looked at the feasibility of conducting a clinical trial in the outpatient and inpatient rehab setting exploring how individuals post stroke respond to different focus of attention cues. Focus of attention refers to whether individuals in are thinking about how their body is moving, internal focus, or on the effect their body has on the environment, external focus, during motor task. This trial will specifically look at the effect focus of attention has on motor performance and learning in individuals post stroke during lateral seated weight shifting task.
Detailed Description
This was a two phase feasibility study exploring appropriate management, setting, participants including inclusion and exclusion criteria, attrition rates, protocol, and retention. Outcome data for each stage were collected during baseline, acquisition, short-term, and long-term retention.
There were two primary objectives of this two phase feasibility study. The first was to uncover some potential short comings in research designs used in this area. The second was to explore the feasibility of a study in both the chronic and acute stroke populations in a rural community. Topics of feasibility include recruitment, retention, and specific inclusion and exclusion criteria. Extending the work by Muckel and Merholz, this feasibility study examined performance of individuals post stroke during a seated lateral weight shifting task and incorporated retention trials, quality of movement exploration, and bilateral weight shifting.
During Phase I, individuals in both groups sat unsupported on a hi-lo mat table which was adjusted so participants were sitting at 90 degrees hip and knee flexion with feet shoulder width apart. Tape marks were used to mark initial set up ensuring standardized positioning for each trial. Following baseline trials, all participants watched the same instructional video describing lateral weight shifting. The instructions included correct mechanics that should be used when weight shifting laterally with focus on correct form needed for the movement.
Testing included baseline, acquisition, short term retention (5 minutes later), and long-term retention (7-10 days later). Participants performed three trials of seated weight shifting to each side at all timepoints. During acquisition, the internal focus group was instructed to "shift your weight as much as possible towards your right or left hip without using your arms". The external focus group sat with targets one arm length away at shoulder height and were instructed to "shift your body weight as much as possible towards the blue/orange target without using your arms." During baseline and retention trials, adults were instructed to "lean as far as you can to the right/left without using your arms." During Phase II, the protocol was similar except 6 trials were performed for acquisition to potentially improve motor learning, which was not significant in Phase I per retention data. Other changes to the protocol included allowing participants to move their feet when weight-shifting. Instructions were also revised. The external focus group was told to "move your shoulder as close to the blue/orange target as possible", while the internal focus group was told to "shift your body weight as much as possible towards your right/left hip without using your arms."
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident
Keywords
Focus of attention, Motor learning, Seated weight shifting
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two independent groups measured at 4 timepoints, baseline, acquisition, short-term, and long-term retention.
Masking
ParticipantOutcomes Assessor
Masking Description
Participants were blinded from whether they were in control or experimental group and statistician was blinded.
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Focus of attention in individuals post chronic stroke during seated lateral weight shifting
Arm Type
Experimental
Arm Description
Feasibility study
Arm Title
Focus of attention in individuals post acute stroke during seated lateral weight shifting
Arm Type
Experimental
Arm Description
Feasibility study
Intervention Type
Behavioral
Intervention Name(s)
Focus of attention
Other Intervention Name(s)
Seated lateral weight shifting
Intervention Description
Individuals were asked to laterally weight shift while seated with either internal focus or external focus instructions.
Primary Outcome Measure Information:
Title
Recruitment
Description
Percentage of participants recruited out of the estimated number needed by power analysis. Power analyses revealed 42 participants were needed for 2X4 mixed model ANOVA 193 analysis, a=.05, power=.8, with a medium effect size, f=.2.
Time Frame
One year for each arm of the study.
Title
Retention
Description
Percentage of participants that completed all 4 timepoints, baseline, acquisition, short term, and long term retention out of those that completed baseline trials.
Time Frame
One year for each arm of the study.
Secondary Outcome Measure Information:
Title
Shoulder alignment during baseline to affected side
Description
Only used in arm 2 of the study. Angle measuring a line from acromion to acromion compared to a horizontal plumb line. This is a repeated measure over 4 time points. This measurement will occur during each lateral weight shift for all participants. Pt's will shift to either side 3 times during baseline, short term and long term retention. Participants shifted to both sides 6 times to each side during arm 2 of the study. Averages were used for data analysis.
A 9.5" X 7.31" X 0.37" 4th generation iPad†, with a 9.7-inch retina display, was used to record videos of each trial. The iPad has a 1080p HD video and 1.2 MP photo camera with autofocus and a 2.4 aperture with video stabilization. From this footage, shoulder alignment was measured during seated lateral weight shifting using the Body Align Pro app‡, trademarked on Nov. 28, 2014.
Time Frame
baseline (prior to training)
Title
Shoulder alignment during baseline to unaffected side
Description
Only used in arm 2 of the study. Angle measuring a line from acromion to acromion compared to a horizontal plumb line. This is a repeated measure over 4 time points. This measurement will occur during each lateral weight shift for all participants. Pt's will shift to either side 3 times during baseline, short term and long term retention. Participants shifted to both sides 6 times to each side during arm 2 of the study. Averages were used for data analysis.
A 9.5" X 7.31" X 0.37" 4th generation iPad†, with a 9.7-inch retina display, was used to record videos of each trial. The iPad has a 1080p HD video and 1.2 MP photo camera with autofocus and a 2.4 aperture with video stabilization. From this footage, shoulder alignment was measured during seated lateral weight shifting using the Body Align Pro app‡, trademarked on Nov. 28, 2014.
Time Frame
baseline (prior to training)
Title
Shoulder alignment during acquisition or training to affected side
Description
Arm 2 only. Angle measuring a line from acromion to acromion compared to a horizontal plumb line. This is a repeated measure over 4 time points. This measurement will occur during each lateral weight shift for all participants. Pt's will shift to either side 3 times during baseline, short term and long term retention. Participants shifted to both sides 6 times to each side during arm 2 of the study. Averages were used for data analysis.Baseline measurements are taken, then participants are given a 2 minute demonstration of what to do during training. The training or acquisition occurs right afterwards.A 9.5" X 7.31" X 0.37" 4th generation iPad†, with a 9.7-inch retina display, was used to record videos of each trial. The iPad has a 1080p HD video and 1.2 MP photo camera with autofocus and a 2.4 aperture with video stabilization. From this footage, shoulder alignment was measured during seated lateral weight shifting using the Body Align Pro app‡, trademarked on Nov. 28, 2014.
Time Frame
acquisition (30 minutes) through study completion, average of one year.
Title
Shoulder alignment during acquisition or training to unaffected side
Description
Arm 2 only. Angle measuring a line from acromion to acromion compared to a horizontal plumb line. This is a repeated measure over 4 time points. This measurement will occur during each lateral weight shift for all participants. Pt's will shift to either side 3 times during baseline, short term and long term retention. Participants shifted to both sides 6 times to each side during arm 2 of the study. Averages were used for data analysis. Baseline measurements are taken, then participants are given a 2 minute demonstration of what to do during training. The training or acquisition occurs right afterwards. A 9.5" X 7.31" X 0.37" 4th generation iPad†, with a 9.7-inch retina display, was used to record videos of each trial. The iPad has a 1080p HD video and 1.2 MP photo camera with autofocus and a 2.4 aperture with video stabilization. From this footage, shoulder alignment was measured during seated lateral weight shifting using the Body Align Pro app‡, trademarked on Nov. 28, 2014.
Time Frame
acquisition (30 minutes) through study completion, average of one year.
Title
Shoulder alignment during short term retention to affected side
Description
Only used in arm 2 of the study. Angle measuring a line from acromion to acromion compared to a horizontal plumb line. This is a repeated measure over 4 time points. This measurement will occur during each lateral weight shift for all participants. Pt's will shift to either side 3 times during baseline, short term and long term retention. Participants shifted to both sides 6 times to each side during arm 2 of the study. Averages were used for data analysis.
A 9.5" X 7.31" X 0.37" 4th generation iPad†, with a 9.7-inch retina display, was used to record videos of each trial. The iPad has a 1080p HD video and 1.2 MP photo camera with autofocus and a 2.4 aperture with video stabilization. From this footage, shoulder alignment was measured during seated lateral weight shifting using the Body Align Pro app‡, trademarked on Nov. 28, 2014.
Time Frame
short-term (5 minutes after training)
Title
Shoulder alignment during short term retention to unaffected side
Description
Only used in arm 2 of the study. Angle measuring a line from acromion to acromion compared to a horizontal plumb line. This is a repeated measure over 4 time points. This measurement will occur during each lateral weight shift for all participants. Pt's will shift to either side 3 times during baseline, short term and long term retention. Participants shifted to both sides 6 times to each side during arm 2 of the study. Averages were used for data analysis.
A 9.5" X 7.31" X 0.37" 4th generation iPad†, with a 9.7-inch retina display, was used to record videos of each trial. The iPad has a 1080p HD video and 1.2 MP photo camera with autofocus and a 2.4 aperture with video stabilization. From this footage, shoulder alignment was measured during seated lateral weight shifting using the Body Align Pro app‡, trademarked on Nov. 28, 2014.
Time Frame
short-term (5 minutes after training)
Title
Shoulder alignment during long term retention to affected side
Description
Only used in arm 2 of the study. Angle measuring a line from acromion to acromion compared to a horizontal plumb line. This is a repeated measure over 4 time points. This measurement will occur during each lateral weight shift for all participants. Pt's will shift to either side 3 times during baseline, short term and long term retention. Participants shifted to both sides 6 times to each side during arm 2 of the study. Averages were used for data analysis.
A 9.5" X 7.31" X 0.37" 4th generation iPad†, with a 9.7-inch retina display, was used to record videos of each trial. The iPad has a 1080p HD video and 1.2 MP photo camera with autofocus and a 2.4 aperture with video stabilization. From this footage, shoulder alignment was measured during seated lateral weight shifting using the Body Align Pro app‡, trademarked on Nov. 28, 2014.
Time Frame
long-term (7 days after training)
Title
Shoulder alignment during long term retention to unaffected side
Description
Only used in arm 2 of the study. Angle measuring a line from acromion to acromion compared to a horizontal plumb line. This is a repeated measure over 4 time points. This measurement will occur during each lateral weight shift for all participants. Pt's will shift to either side 3 times during baseline, short term and long term retention. Participants shifted to both sides 6 times to each side during arm 2 of the study. Averages were used for data analysis.
A 9.5" X 7.31" X 0.37" 4th generation iPad†, with a 9.7-inch retina display, was used to record videos of each trial. The iPad has a 1080p HD video and 1.2 MP photo camera with autofocus and a 2.4 aperture with video stabilization. From this footage, shoulder alignment was measured during seated lateral weight shifting using the Body Align Pro app‡, trademarked on Nov. 28, 2014.
Time Frame
long-term (7 days after training)
Title
Seated lateral excursion during baseline to affected side
Description
Measure of how far individuals shifted their center of pressure laterally during each weight shift trial (cm). This is a repeated measure over 4 time points. This measurement will occur during each lateral weight shift for all participants. Pt's will shift to either side 3 times during baseline, short term and long term retention. In arm 1 participants shifted to both sides 3 times during the acquisition trials and 6 times to each side during arm 2 of the study.
A 32X32 array BodiTrak* pressure mat with an 18.125 in x 18.125 in sensing area (1,024 sensors) was used to measure lateral excursion of center of pressure during each trial for both phases. The pressure mat has a 200 mmHg calibration range and up to 150 Hz sampling frame rate.
Time Frame
baseline (prior to training)
Title
Seated lateral excursion during baseline to unaffected side
Description
Measure of how far individuals shifted their center of pressure laterally during each weight shift trial (cm). This is a repeated measure over 4 time points. This measurement will occur during each lateral weight shift for all participants. Pt's will shift to either side 3 times during baseline, short term and long term retention. In arm 1 participants shifted to both sides 3 times during the acquisition trials and 6 times to each side during arm 2 of the study.
A 32X32 array BodiTrak* pressure mat with an 18.125 in x 18.125 in sensing area (1,024 sensors) was used to measure lateral excursion of center of pressure during each trial for both phases. The pressure mat has a 200 mmHg calibration range and up to 150 Hz sampling frame rate.
Time Frame
baseline (prior to training)
Title
Seated lateral excursion during acquisition or training to affected side
Description
Measure of how far individuals shifted their center of pressure laterally during each weight shift trial (cm). This is a repeated measure over 4 time points. This measurement will occur during each lateral weight shift for all participants. Pt's will shift to either side 3 times during baseline, short term and long term retention. In arm 1 participants shifted to both sides 3 times during the acquisition trials and 6 times to each side during arm 2 of the study. Baseline measurements are taken, then participants are given a 2 minute demonstration of what to do during training. The training or acquisition occurs right after this demonstration and occurs for 30 minutes.
A 32X32 array BodiTrak* pressure mat with an 18.125 in x 18.125 in sensing area (1,024 sensors) was used to measure lateral excursion of center of pressure during each trial for both phases. The pressure mat has a 200 mmHg calibration range and up to 150 Hz sampling frame rate.
Time Frame
acquisition (30 minutes) through study completion, average of one year.
Title
Seated lateral excursion during acquisition or training to unaffected side
Description
Measure of how far individuals shifted their center of pressure laterally during each weight shift trial (cm). This is a repeated measure over 4 time points. This measurement will occur during each lateral weight shift for all participants. Pt's will shift to either side 3 times during baseline, short term and long term retention. In arm 1 participants shifted to both sides 3 times during the acquisition trials and 6 times to each side during arm 2 of the study. Baseline measurements are taken, then participants are given a 2 minute demonstration of what to do during training. The training or acquisition occurs right after this demonstration and occurs for 30 minutes.
A 32X32 array BodiTrak* pressure mat with an 18.125 in x 18.125 in sensing area (1,024 sensors) was used to measure lateral excursion of center of pressure during each trial for both phases. The pressure mat has a 200 mmHg calibration range and up to 150 Hz sampling frame rate.
Time Frame
acquisition (30 minutes) through study completion, average of one year.
Title
Seated lateral excursion during short-term retention to affected side
Description
Measure of how far individuals shifted their center of pressure laterally during each weight shift trial (cm). This is a repeated measure over 4 time points. This measurement will occur during each lateral weight shift for all participants. Pt's will shift to either side 3 times during baseline, short term and long term retention. In arm 1 participants shifted to both sides 3 times during the acquisition trials and 6 times to each side during arm 2 of the study.
A 32X32 array BodiTrak* pressure mat with an 18.125 in x 18.125 in sensing area (1,024 sensors) was used to measure lateral excursion of center of pressure during each trial for both phases. The pressure mat has a 200 mmHg calibration range and up to 150 Hz sampling frame rate.
Time Frame
short-term (5 minutes after training)
Title
Seated lateral excursion during short-term retention to unaffected side
Description
Measure of how far individuals shifted their center of pressure laterally during each weight shift trial (cm). This is a repeated measure over 4 time points. This measurement will occur during each lateral weight shift for all participants. Pt's will shift to either side 3 times during baseline, short term and long term retention. In arm 1 participants shifted to both sides 3 times during the acquisition trials and 6 times to each side during arm 2 of the study.
A 32X32 array BodiTrak* pressure mat with an 18.125 in x 18.125 in sensing area (1,024 sensors) was used to measure lateral excursion of center of pressure during each trial for both phases. The pressure mat has a 200 mmHg calibration range and up to 150 Hz sampling frame rate.
Time Frame
short-term (5 minutes after training)
Title
Seated lateral excursion during long-term retention to affected side
Description
Measure of how far individuals shifted their center of pressure laterally during each weight shift trial (cm). This is a repeated measure over 4 time points. This measurement will occur during each lateral weight shift for all participants. Pt's will shift to either side 3 times during baseline, short term and long term retention. In arm 1 participants shifted to both sides 3 times during the acquisition trials and 6 times to each side during arm 2 of the study.
A 32X32 array BodiTrak* pressure mat with an 18.125 in x 18.125 in sensing area (1,024 sensors) was used to measure lateral excursion of center of pressure during each trial for both phases. The pressure mat has a 200 mmHg calibration range and up to 150 Hz sampling frame rate.
Time Frame
long-term (7 days after training)
Title
Seated lateral excursion during long-term retention to unaffected side
Description
Measure of how far individuals shifted their center of pressure laterally during each weight shift trial (cm). This is a repeated measure over 4 time points. This measurement will occur during each lateral weight shift for all participants. Pt's will shift to either side 3 times during baseline, short term and long term retention. In arm 1 participants shifted to both sides 3 times during the acquisition trials and 6 times to each side during arm 2 of the study.
A 32X32 array BodiTrak* pressure mat with an 18.125 in x 18.125 in sensing area (1,024 sensors) was used to measure lateral excursion of center of pressure during each trial for both phases. The pressure mat has a 200 mmHg calibration range and up to 150 Hz sampling frame rate.
Time Frame
long-term (7 days after training)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
participants with history of stroke
ability to sit statically without physical assistance
Exclusion Criteria:
severe hemineglect (star cancellation test <44/54)
inability to follow multistep commands
orthopedic issues that limited their ability to weight shift including severe hip or back pain
individuals with other neurologic conditions such as dementia
individuals with contraversive pushing.
During the first arm (phase) of the study there were age matched healthy controls.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashley W Hyatt, DPT
Organizational Affiliation
Western Carolina University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western Carolina University
City
Cullowhee
State/Province
North Carolina
ZIP/Postal Code
28723
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Focus of Attention in Individuals With Stroke
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