- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT04696302
Focus of Attention in Individuals With Stroke
Focus of Attention Effects on Motor Performance and Learning in Individuals Post Stroke During Seated Lateral Weight Shifting: A Two-phase Feasibility Study
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
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."
Tanulmány típusa
Beiratkozás (Tényleges)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi helyek
-
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North Carolina
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Cullowhee, North Carolina, Egyesült Államok, 28723
- Western Carolina University
-
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
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.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Kettős
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
---|---|
Kísérleti: Focus of attention in individuals post chronic stroke during seated lateral weight shifting
Feasibility study
|
Individuals were asked to laterally weight shift while seated with either internal focus or external focus instructions.
Más nevek:
|
Kísérleti: Focus of attention in individuals post acute stroke during seated lateral weight shifting
Feasibility study
|
Individuals were asked to laterally weight shift while seated with either internal focus or external focus instructions.
Más nevek:
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Recruitment
Időkeret: One year for each arm of the study.
|
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.
|
One year for each arm of the study.
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Retention
Időkeret: One year for each arm of the study.
|
Percentage of participants that completed all 4 timepoints, baseline, acquisition, short term, and long term retention out of those that completed baseline trials.
|
One year for each arm of the study.
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Shoulder alignment during baseline to affected side
Időkeret: baseline (prior to training)
|
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. |
baseline (prior to training)
|
Shoulder alignment during baseline to unaffected side
Időkeret: baseline (prior to training)
|
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. |
baseline (prior to training)
|
Shoulder alignment during acquisition or training to affected side
Időkeret: acquisition (30 minutes) through study completion, average of one year.
|
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.
|
acquisition (30 minutes) through study completion, average of one year.
|
Shoulder alignment during acquisition or training to unaffected side
Időkeret: acquisition (30 minutes) through study completion, average of one year.
|
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.
|
acquisition (30 minutes) through study completion, average of one year.
|
Shoulder alignment during short term retention to affected side
Időkeret: short-term (5 minutes after training)
|
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. |
short-term (5 minutes after training)
|
Shoulder alignment during short term retention to unaffected side
Időkeret: short-term (5 minutes after training)
|
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. |
short-term (5 minutes after training)
|
Shoulder alignment during long term retention to affected side
Időkeret: long-term (7 days after training)
|
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. |
long-term (7 days after training)
|
Shoulder alignment during long term retention to unaffected side
Időkeret: long-term (7 days after training)
|
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. |
long-term (7 days after training)
|
Seated lateral excursion during baseline to affected side
Időkeret: baseline (prior to training)
|
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. |
baseline (prior to training)
|
Seated lateral excursion during baseline to unaffected side
Időkeret: baseline (prior to training)
|
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. |
baseline (prior to training)
|
Seated lateral excursion during acquisition or training to affected side
Időkeret: acquisition (30 minutes) through study completion, average of one year.
|
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. |
acquisition (30 minutes) through study completion, average of one year.
|
Seated lateral excursion during acquisition or training to unaffected side
Időkeret: acquisition (30 minutes) through study completion, average of one year.
|
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. |
acquisition (30 minutes) through study completion, average of one year.
|
Seated lateral excursion during short-term retention to affected side
Időkeret: short-term (5 minutes after training)
|
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. |
short-term (5 minutes after training)
|
Seated lateral excursion during short-term retention to unaffected side
Időkeret: short-term (5 minutes after training)
|
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. |
short-term (5 minutes after training)
|
Seated lateral excursion during long-term retention to affected side
Időkeret: long-term (7 days after training)
|
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. |
long-term (7 days after training)
|
Seated lateral excursion during long-term retention to unaffected side
Időkeret: long-term (7 days after training)
|
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. |
long-term (7 days after training)
|
Együttműködők és nyomozók
Szponzor
Együttműködők
Nyomozók
- Kutatásvezető: Ashley W Hyatt, DPT, Western Carolina University
Publikációk és hasznos linkek
Általános kiadványok
- Virani SS, Alonso A, Benjamin EJ, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Chang AR, Cheng S, Delling FN, Djousse L, Elkind MSV, Ferguson JF, Fornage M, Khan SS, Kissela BM, Knutson KL, Kwan TW, Lackland DT, Lewis TT, Lichtman JH, Longenecker CT, Loop MS, Lutsey PL, Martin SS, Matsushita K, Moran AE, Mussolino ME, Perak AM, Rosamond WD, Roth GA, Sampson UKA, Satou GM, Schroeder EB, Shah SH, Shay CM, Spartano NL, Stokes A, Tirschwell DL, VanWagner LB, Tsao CW; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2020 Update: A Report From the American Heart Association. Circulation. 2020 Mar 3;141(9):e139-e596. doi: 10.1161/CIR.0000000000000757. Epub 2020 Jan 29.
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- Shafizadeh M, Platt GK, Mohammadi B. Effects of different focus of attention rehabilitative training on gait performance in Multiple Sclerosis patients. J Bodyw Mov Ther. 2013 Jan;17(1):28-34. doi: 10.1016/j.jbmt.2012.04.005. Epub 2012 May 10.
- McKay B, Wulf G. A distal external focus enhances novice dart throwing performance. Int J Sport Exerc Psychol. 2012;10(2):149-156. doi:10.1080/1612197X.2012.682356
- McNevin NH, Shea CH, Wulf G. Increasing the distance of an external focus of attention enhances learning. Psychol Res. 2003 Feb;67(1):22-9. doi: 10.1007/s00426-002-0093-6. Epub 2002 Oct 30.
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- McNevin N, Weir P, Quinn T. Effects of attentional focus and age on suprapostural task performance and postural control. Res Q Exerc Sport. 2013 Mar;84(1):96-103. doi: 10.1080/02701367.2013.762321.
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 949671-4
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
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Brown UniversityKeitner/Family Therapy Research GrantBefejezveMellrák | Szexuális diszfunkció | Prosztata rákEgyesült Államok
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University of California, Los AngelesAktív, nem toborzóDepresszió | Stressz, pszichológiai | Stressz zavarok, traumás | Szorongás | Szülő-gyermek kapcsolatok | Nevelés | Érzelmi stressz | Megküzdési készségek | Érzelemszabályozás | Trauma, pszichológiai | Viselkedés, gyermekEgyesült Államok
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Umeå UniversityMég nincs toborzásCsípőtáji törések | Érzéstelenítés | Hemodinamikai instabilitás | Echokardiográfia | Kockázatértékelés
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University of WashingtonPatient-Centered Outcomes Research InstituteMég nincs toborzásSkizofrénia | Bipoláris zavar | Major depresszív zavar | Schizo affektív zavar
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University of California, Los AngelesBefejezveDepresszió | Stressz, pszichológiai | Stressz zavarok, traumás | Szorongás | Érzelmi stressz | Trauma, pszichológiai | Viselkedés, gyermek | Szabályozás, Self
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A. Vogel AGUniversity of Newcastle Upon-TyneJelentkezés meghívóvalMentális egészség Wellness 1 | Munkával kapcsolatos stresszEgyesült Királyság
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University of California, Los AngelesVA Greater Los Angeles Healthcare SystemVisszavontVeterán családok | Családi kommunikáció | A civil élet reintegrációjaEgyesült Államok