NCT04696302

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 23, 2015

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

December 16, 2020

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 6, 2021

Completed
Last Updated

January 6, 2021

Status Verified

January 1, 2021

Enrollment Period

4.1 years

First QC Date

December 16, 2020

Last Update Submit

January 3, 2021

Conditions

Keywords

Focus of attentionMotor learningSeated weight shifting

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    One year for each arm of the study.

Secondary Outcomes (16)

  • Shoulder alignment during baseline to affected side

    baseline (prior to training)

  • Shoulder alignment during baseline to unaffected side

    baseline (prior to training)

  • Shoulder alignment during acquisition or training to affected side

    acquisition (30 minutes) through study completion, average of one year.

  • Shoulder alignment during acquisition or training to unaffected side

    acquisition (30 minutes) through study completion, average of one year.

  • Shoulder alignment during short term retention to affected side

    short-term (5 minutes after training)

  • +11 more secondary outcomes

Study Arms (2)

Focus of attention in individuals post chronic stroke during seated lateral weight shifting

EXPERIMENTAL

Feasibility study

Behavioral: Focus of attention

Focus of attention in individuals post acute stroke during seated lateral weight shifting

EXPERIMENTAL

Feasibility study

Behavioral: Focus of attention

Interventions

Individuals were asked to laterally weight shift while seated with either internal focus or external focus instructions.

Also known as: Seated lateral weight shifting
Focus of attention in individuals post acute stroke during seated lateral weight shiftingFocus of attention in individuals post chronic stroke during seated lateral weight shifting

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • participants with history of stroke
  • ability to sit statically without physical assistance

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western Carolina University

Cullowhee, North Carolina, 28723, United States

Location

Related Publications (25)

  • 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: 31992061BACKGROUND
  • Wulf G. Attentional focus and motor learning: A review of 15 years. Int Rev Sport Exerc Psychol. 2013;6(1):77-104. doi:10.1080/1750984X.2012.723728

    BACKGROUND
  • Kal EC, van der Kamp J, Houdijk H. External attentional focus enhances movement automatization: a comprehensive test of the constrained action hypothesis. Hum Mov Sci. 2013 Aug;32(4):527-39. doi: 10.1016/j.humov.2013.04.001. Epub 2013 Jun 30.

    PMID: 24054892BACKGROUND
  • Kakebeeke T, Knols R, de Bruin E. Should rehabilitation specialists use external focus instructions when motor learning is fostered? A systematic review. Sports. 2013;1(2):37-54. doi:10.3390/sports1020037

    BACKGROUND
  • 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: 11765737BACKGROUND
  • Sturmberg C, Marquez J, Heneghan N, Snodgrass S, van Vliet P. Attentional focus of feedback and instructions in the treatment of musculoskeletal dysfunction: a systematic review. Man Ther. 2013 Dec;18(6):458-67. doi: 10.1016/j.math.2013.07.002. Epub 2013 Sep 3.

    PMID: 24008053BACKGROUND
  • McNevin NH, Wulf G, Carlson C. Effects of attentional focus, self-control, and dyad training on motor learning: implications for physical rehabilitation. Phys Ther. 2000 Apr;80(4):373-85. doi: 10.1093/ptj/80.4.373.

    PMID: 10758522BACKGROUND
  • Masters RSW. Knowledge, knerves and know-how: The role of explicit versus implicit knowledge in the breakdown of a complex motor skill under pressure. Br J Psychol. 1992;83:343-358.

    BACKGROUND
  • 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: 26317437BACKGROUND
  • 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: 30168348BACKGROUND
  • 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: 28652064BACKGROUND
  • 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: 23796803BACKGROUND
  • 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: 12125827BACKGROUND
  • 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: 24452700BACKGROUND
  • Ziv G, Lidor R. Attentional focus and motor learning in clinical settings and in older age: A review. J Mot Learn Dev. 2015;3(2):123-139. doi:10.1123/jmld.2015-0014

    BACKGROUND
  • Perennou DA, Mazibrada G, Chauvineau V, Greenwood R, Rothwell J, Gresty MA, Bronstein AM. Lateropulsion, pushing and verticality perception in hemisphere stroke: a causal relationship? Brain. 2008 Sep;131(Pt 9):2401-13. doi: 10.1093/brain/awn170. Epub 2008 Aug 4.

    PMID: 18678565BACKGROUND
  • Becker K, Smith PJ. Age, task complexity, and sex as potential moderators of attentional focus effects. Percept Mot Skills. 2013 Aug;117(1):1172-86. doi: 10.2466/23.25.pms.117x14z3.

    PMID: 24422344BACKGROUND
  • Johnson L, Burridge JH, Demain SH. Internal and external focus of attention during gait re-education: an observational study of physical therapist practice in stroke rehabilitation. Phys Ther. 2013 Jul;93(7):957-66. doi: 10.2522/ptj.20120300. Epub 2013 Apr 4.

    PMID: 23559523BACKGROUND
  • 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.

    PMID: 23294680BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 12589447BACKGROUND
  • Kal E, van den Brink H, Houdijk H, van der Kamp J, Goossens PH, van Bennekom C, Scherder E. How physical therapists instruct patients with stroke: an observational study on attentional focus during gait rehabilitation after stroke. Disabil Rehabil. 2018 May;40(10):1154-1165. doi: 10.1080/09638288.2017.1290697. Epub 2017 Feb 24.

    PMID: 28637152BACKGROUND
  • Lam JM, Globas C, Hosp JA, Karnath HO, Wachter T, Luft AR. Impaired implicit learning and feedback processing after stroke. Neuroscience. 2016 Feb 9;314:116-24. doi: 10.1016/j.neuroscience.2015.11.051. Epub 2015 Nov 27.

    PMID: 26633264BACKGROUND
  • Chiviacowsky S, Wulf G, Wally R. An external focus of attention enhances balance learning in older adults. Gait Posture. 2010 Oct;32(4):572-5. doi: 10.1016/j.gaitpost.2010.08.004. Epub 2010 Sep 17.

    PMID: 20850325BACKGROUND
  • 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.

    PMID: 23611013BACKGROUND

Related Links

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Ashley W Hyatt, DPT

    Western Carolina University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants were blinded from whether they were in control or experimental group and statistician was blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two independent groups measured at 4 timepoints, baseline, acquisition, short-term, and long-term retention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Physical Therapy

Study Record Dates

First Submitted

December 16, 2020

First Posted

January 6, 2021

Study Start

March 23, 2015

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

January 6, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations