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.
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."
Individuals were asked to laterally weight shift while seated with either internal focus or external focus instructions.
Western Carolina University
Cullowhee, North Carolina, United States
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.
Time frame: One year for each arm of the study.
Retention
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.
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.
Time frame: baseline (prior to training)
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.
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Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
38
Time frame: baseline (prior to training)
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.
Time frame: acquisition (30 minutes) through study completion, average of one year.
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.
Time frame: acquisition (30 minutes) through study completion, average of one year.
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.
Time frame: short-term (5 minutes after training)
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.
Time frame: short-term (5 minutes after training)
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.
Time frame: long-term (7 days after training)
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.
Time frame: long-term (7 days after training)
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.
Time frame: baseline (prior to training)
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.
Time frame: baseline (prior to training)
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.
Time frame: acquisition (30 minutes) through study completion, average of one year.
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.
Time frame: acquisition (30 minutes) through study completion, average of one year.
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.
Time frame: short-term (5 minutes after training)
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.
Time frame: short-term (5 minutes after training)
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.
Time frame: long-term (7 days after training)
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.
Time frame: long-term (7 days after training)