FOA on Sit to Stand in Individuals Post Stroke

NCT05874661 | Unknown

• 2 other identifiers: WesternCarolinaUFull PhD Dissertation Study
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief Summary

Focus of attention refers to what a person is thinking about during a task, with an internal focus being thinking about what one's body is doing and an external focus being thinking about a target or outcome in the environment. The purpose of this study is to fill some of the gaps in the literature by examining the effects of focus of attention on performance and learning of sit to stand in individuals post stroke. This study will investigate whether an internal or external focus of attention can lead to improved use of the affected lower extremity during the sit to stand transition, while maintaining an upright trunk position.

Conditions

Stroke, Acute

Keywords

Focus of Attention; Motor Learning; Sit to Stand

Outcome Measures

Primary Outcomes (11)

• Proportion of force under affected lower extremity

  HR Pressure mat - Symmetry under the feet will be measured using a 61.26 X 58.72 cm pedobarograph with a 48.8 X 44.7 cm active sensing area during the sit to stand transition. The mat has 3.9 sensors/cm2 with a 185 Hz scanning rate. The mat will be calibrated prior to the start of the study.

  Baseline

• Proportion of force under affected lower extremity

  HR Pressure mat - Symmetry under the feet will be measured using a 61.26 X 58.72 cm pedobarograph with a 48.8 X 44.7 cm active sensing area during the sit to stand transition. The mat has 3.9 sensors/cm2 with a 185 Hz scanning rate. The mat will be calibrated prior to the start of the study.

  Acquisition (one 1 hour training)

• Proportion of force under affected lower extremity

  HR Pressure mat - Symmetry under the feet will be measured using a 61.26 X 58.72 cm pedobarograph with a 48.8 X 44.7 cm active sensing area during the sit to stand transition. The mat has 3.9 sensors/cm2 with a 185 Hz scanning rate. The mat will be calibrated prior to the start of the study.

  Short term (5 minutes after training)

• Proportion of force under affected lower extremity

  HR Pressure mat - Symmetry under the feet will be measured using a 61.26 X 58.72 cm pedobarograph with a 48.8 X 44.7 cm active sensing area during the sit to stand transition. The mat has 3.9 sensors/cm2 with a 185 Hz scanning rate. The mat will be calibrated prior to the start of the study.

  Long term (1 hour after training)

• Trunk alignment

  IMU sensors -One Delsys inertial measurement units (IMUs) will be placed on the sternum just inferior to the sternal notch to capture vertical trunk alignment throughout sit to stand.

  Baseline

• Trunk alignment

  IMU sensors -One Delsys inertial measurement units (IMUs) will be placed on the sternum just inferior to the sternal notch to capture vertical trunk alignment throughout sit to stand.

  Acquisition (1 hour training)

• Trunk alignment

  IMU sensors -One Delsys inertial measurement units (IMUs) will be placed on the sternum just inferior to the sternal notch to capture vertical trunk alignment throughout sit to stand.

  Short term (5 minutes post training)

• Trunk alignment

  IMU sensors -One Delsys inertial measurement units (IMUs) will be placed on the sternum just inferior to the sternal notch to capture vertical trunk alignment throughout sit to stand.

  Long term (1 hour post training)

• Gait symmetry

  GaitRite - A 20'X 4' GAITRite will be used to gather gait speed and analyze spatial temporal aspects of gait. The GAITRite mat is an electronic walkway which uses pressure activated sensors to map out foot placement during gait using a quadrilateral blocking system. The walkway is made up of sensor pads, each of which has 2,304 sensors arranged in 48X48 grids. The measurements are provided using x,y coordinates and algorithms in the computer system use this information to group sensors into footprints. The mat has a spatial resolution of 1.27 cm and a spatial resolution accuracy of 1.27 cm. The mat will be set at 120 Hz sampling rate. All other parameters are fixed. GAITRite software will be used to collect percent of time spent in affected lower extremity stance compared to total stance time.

  Baseline

• Gait symmetry

  GaitRite - A 20'X 4' GAITRite will be used to gather gait speed and analyze spatial temporal aspects of gait. The GAITRite mat is an electronic walkway which uses pressure activated sensors to map out foot placement during gait using a quadrilateral blocking system. The walkway is made up of sensor pads, each of which has 2,304 sensors arranged in 48X48 grids. The measurements are provided using x,y coordinates and algorithms in the computer system use this information to group sensors into footprints. The mat has a spatial resolution of 1.27 cm and a spatial resolution accuracy of 1.27 cm. The mat will be set at 120 Hz sampling rate. All other parameters are fixed. GAITRite software will be used to collect percent of time spent in affected lower extremity stance compared to total stance time.

  Short term (5 minutes after training)

• Gait symmetry

  GaitRite - A 20'X 4' GAITRite will be used to gather gait speed and analyze spatial temporal aspects of gait. The GAITRite mat is an electronic walkway which uses pressure activated sensors to map out foot placement during gait using a quadrilateral blocking system. The walkway is made up of sensor pads, each of which has 2,304 sensors arranged in 48X48 grids. The measurements are provided using x,y coordinates and algorithms in the computer system use this information to group sensors into footprints. The mat has a spatial resolution of 1.27 cm and a spatial resolution accuracy of 1.27 cm. The mat will be set at 120 Hz sampling rate. All other parameters are fixed. GAITRite software will be used to collect percent of time spent in affected lower extremity stance compared to total stance time.

  Long term (1 hour after training)

Study Arms (2)

Internal Focus of Attention Group

ACTIVE COMPARATOR

Participants will be given instructions that make them think about their body's movements. Participants assigned to this condition first will complete the external focus condition second in the cross over.

Other: Internal Focus of Attention

Extneral Focus of Attention Group

EXPERIMENTAL

Participants will be given instructions that make them think about an outside target or outcome. Participants assigned to this condition first will complete the internal focus condition second in the cross over.

Other: External Focus of Attention

Interventions

External Focus of Attention OTHER

Focus of attention refers to what a person is thinking about during a task, with an external focus being thinking about a target or outcome in the environment.

Extneral Focus of Attention Group

Internal Focus of Attention OTHER

Focus of attention refers to what a person is thinking about during a task, with an internal focus being thinking about what one's body is doing.

Internal Focus of Attention Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• post stroke \<6 months
• at least 18 years of age, of any gender, race, or ethnic group

You may not qualify if:

• Unable to stand unassisted from a standard height, 20" chair, with or without upper extremity assistance
• Unable to ambulate 20 feet without physical assistance or
• Moderate to severely impaired cognition with a score of \<10/30 on the Montreal Cognitive Assessment (MOCA)
• Contraversive pushing with \>1 according to the Scale for Contraversive Pushing Scale
• Neglect as evidenced by \<44/56 on the Star Cancellation Test
• Any orthopedic or other neurologic conditions that impact their ability to transition from sit to stand

Sponsors & Collaborators

• Western Carolina University: lead
• Mission Health System, Asheville, NC: collaborator
• Texas Woman's University: collaborator

Study Sites (2)

CarePartners

Asheville, North Carolina, 28803, United States

RECRUITING

Western Carolina University

Cullowhee, North Carolina, 28723, United States

RECRUITING

Related Publications (25)

• Abdullahi A, Truijen S, Umar NA, Useh U, Egwuonwu VA, Van Criekinge T, Saeys W. Effects of Lower Limb Constraint Induced Movement Therapy in People With Stroke: A Systematic Review and Meta-Analysis. Front Neurol. 2021 Mar 23;12:638904. doi: 10.3389/fneur.2021.638904. eCollection 2021.

  PMID: 33833730 BACKGROUND

• CIR Sytems. (2013). GAITRite Electronic Walkway Technical Reference. Technical Reference (WI-02-15), 1-50.

  BACKGROUND

• Matscan, F. (2021). Footmat TM user manual 7.1x.

  BACKGROUND

• Orrell AJ, Masters RS, Eves FF. Reinvestment and movement disruption following stroke. Neurorehabil Neural Repair. 2009 Feb;23(2):177-83. doi: 10.1177/1545968308317752. Epub 2008 Nov 5.

  PMID: 18987385 BACKGROUND

• Aloraini SM, Glazebrook CM, Pooyania S, Sibley KM, Singer J, Passmore S. An external focus of attention compared to an internal focus of attention improves anticipatory postural adjustments among people post-stroke. Gait Posture. 2020 Oct;82:100-105. doi: 10.1016/j.gaitpost.2020.08.133. Epub 2020 Aug 29.

  PMID: 32911092 RESULT

• Billinger SA, Guo LX, Pohl PS, Kluding PM. Single limb exercise: pilot study of physiological and functional responses to forced use of the hemiparetic lower extremity. Top Stroke Rehabil. 2010 Mar-Apr;17(2):128-39. doi: 10.1310/tsr1702-128.

  PMID: 20542855 RESULT

• Cheng PT, Liaw MY, Wong MK, Tang FT, Lee MY, Lin PS. The sit-to-stand movement in stroke patients and its correlation with falling. Arch Phys Med Rehabil. 1998 Sep;79(9):1043-6. doi: 10.1016/s0003-9993(98)90168-x.

  PMID: 9749681 RESULT

• Durham KF, Sackley CM, Wright CC, Wing AM, Edwards MG, van Vliet P. Attentional focus of feedback for improving performance of reach-to-grasp after stroke: a randomised crossover study. Physiotherapy. 2014 Jun;100(2):108-15. doi: 10.1016/j.physio.2013.03.004. Epub 2013 Jun 21.

  PMID: 23796803 RESULT

• Fasoli SE, Trombly CA, Tickle-Degnen L, Verfaellie MH. Effect of instructions on functional reach in persons with and without cerebrovascular accident. Am J Occup Ther. 2002 Jul-Aug;56(4):380-90. doi: 10.5014/ajot.56.4.380.

  PMID: 12125827 RESULT

• Hsu CJ, Kim J, Roth EJ, Rymer WZ, Wu M. Forced Use of the Paretic Leg Induced by a Constraint Force Applied to the Nonparetic Leg in Individuals Poststroke During Walking. Neurorehabil Neural Repair. 2017 Dec;31(12):1042-1052. doi: 10.1177/1545968317740972. Epub 2017 Nov 16.

  PMID: 29145773 RESULT

• Kal EC, van der Kamp J, Houdijk H, Groet E, van Bennekom CA, Scherder EJ. Stay Focused! The Effects of Internal and External Focus of Attention on Movement Automaticity in Patients with Stroke. PLoS One. 2015 Aug 28;10(8):e0136917. doi: 10.1371/journal.pone.0136917. eCollection 2015.

  PMID: 26317437 RESULT

• Kal E, Houdijk H, van der Kamp J, Verhoef M, Prosee R, Groet E, Winters M, van Bennekom C, Scherder E. Are the effects of internal focus instructions different from external focus instructions given during balance training in stroke patients? A double-blind randomized controlled trial. Clin Rehabil. 2019 Feb;33(2):207-221. doi: 10.1177/0269215518795243. Epub 2018 Aug 31.

  PMID: 30168348 RESULT

• Katzan, I. L. (2013). Epidemiology of stroke. Handbook of Clinical Nutrition and Stroke, 3-14. https://doi.org/10.1007/978-1-62703-380-0_1

  RESULT

• Kim GJ, Hinojosa J, Rao AK, Batavia M, O'Dell MW. Randomized Trial on the Effects of Attentional Focus on Motor Training of the Upper Extremity Using Robotics With Individuals After Chronic Stroke. Arch Phys Med Rehabil. 2017 Oct;98(10):1924-1931. doi: 10.1016/j.apmr.2017.06.005. Epub 2017 Jun 24.

  PMID: 28652064 RESULT

• Lopez AD, Mathers CD, Ezzati M, Jamison DT, Murray CJ. Global and regional burden of disease and risk factors, 2001: systematic analysis of population health data. Lancet. 2006 May 27;367(9524):1747-57. doi: 10.1016/S0140-6736(06)68770-9.

  PMID: 16731270 RESULT

• Muckel S, Mehrholz J. Immediate effects of two attention strategies on trunk control on patients after stroke. A randomized controlled pilot trial. Clin Rehabil. 2014 Jul;28(7):632-6. doi: 10.1177/0269215513513963. Epub 2014 Jan 22.

  PMID: 24452700 RESULT

• Patterson KK, Parafianowicz I, Danells CJ, Closson V, Verrier MC, Staines WR, Black SE, McIlroy WE. Gait asymmetry in community-ambulating stroke survivors. Arch Phys Med Rehabil. 2008 Feb;89(2):304-10. doi: 10.1016/j.apmr.2007.08.142.

  PMID: 18226655 RESULT

• Tsao CW, Aday AW, Almarzooq ZI, Alonso A, Beaton AZ, Bittencourt MS, Boehme AK, Buxton AE, Carson AP, Commodore-Mensah Y, Elkind MSV, Evenson KR, Eze-Nliam C, Ferguson JF, Generoso G, Ho JE, Kalani R, Khan SS, Kissela BM, Knutson KL, Levine DA, Lewis TT, Liu J, Loop MS, Ma J, Mussolino ME, Navaneethan SD, Perak AM, Poudel R, Rezk-Hanna M, Roth GA, Schroeder EB, Shah SH, Thacker EL, VanWagner LB, Virani SS, Voecks JH, Wang NY, Yaffe K, Martin SS. Heart Disease and Stroke Statistics-2022 Update: A Report From the American Heart Association. Circulation. 2022 Feb 22;145(8):e153-e639. doi: 10.1161/CIR.0000000000001052. Epub 2022 Jan 26.

  PMID: 35078371 RESULT

• Onursal Kilinc O, De Ridder R, Kilinc M, Van Bladel A. Trunk and lower extremity biomechanics during sit-to-stand after stroke: A systematic review. Ann Phys Rehabil Med. 2023 Apr;66(3):101676. doi: 10.1016/j.rehab.2022.101676. Epub 2022 Dec 5.

  PMID: 35597449 RESULT

• 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.

  PMID: 31992061 RESULT

• Wu M, Hsu CJ, Kim J. Forced use of paretic leg induced by constraining the non-paretic leg leads to motor learning in individuals post-stroke. Exp Brain Res. 2019 Oct;237(10):2691-2703. doi: 10.1007/s00221-019-05624-w. Epub 2019 Aug 12.

  PMID: 31407027 RESULT

• Wulf, G. (2013). Attentional focus and motor learning: A review of 15 years. International Review of Sport and Exercise Psychology, 6(1), 77-104. https://doi.org/10.1080/1750984X.2012.723728

  RESULT

• Wulf G, McNevin N, Shea CH. The automaticity of complex motor skill learning as a function of attentional focus. Q J Exp Psychol A. 2001 Nov;54(4):1143-54. doi: 10.1080/713756012.

  PMID: 11765737 RESULT

• Yu WH, Liu WY, Wong AM, Wang TC, Li YC, Lien HY. Effect of forced use of the lower extremity on gait performance and mobility of post-acute stroke patients. J Phys Ther Sci. 2015 Feb;27(2):421-5. doi: 10.1589/jpts.27.421. Epub 2015 Feb 17.

  PMID: 25729182 RESULT

• Zinn S, Bosworth HB, Hoenig HM, Swartzwelder HS. Executive function deficits in acute stroke. Arch Phys Med Rehabil. 2007 Feb;88(2):173-80. doi: 10.1016/j.apmr.2006.11.015.

  PMID: 17270514 RESULT

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ashley W Hyatt, DPT, PhD (C)

  Western Carolina University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashley W Hyatt, DPT, PhD (C)

CONTACT

7176829710; awhyatt@email.wcu.edu

Jeff Scoltock, Masters PT

CONTACT

8285085404; jscoltock@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not be aware of their group allocation compared to the other.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study will be a randomized cross over study. Individuals will be randomized into either an internal or external focus condition for the first week of the study and be crossed over to the other condition in the second week.

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: May 25, 2023
• Study Start: April 2, 2023
• Primary Completion: May 31, 2024
• Study Completion: August 31, 2024
• Last Updated: May 25, 2023

Record last verified: 2023-05

Locations

US (2)