NCT02890446

Brief Summary

This study compares the effects of an internal versus an external focus of attention on motor training of the affected arm for individuals with stroke. Participants were randomly assigned to either the internal or external focus treatment groups and received 12 sessions of arm training.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started May 2014

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

May 1, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 7, 2016

Completed
Last Updated

September 7, 2016

Status Verified

August 1, 2016

Enrollment Period

1.5 years

First QC Date

August 26, 2016

Last Update Submit

August 31, 2016

Conditions

Keywords

attentional focusupper extremityhemiparesisstroke

Outcome Measures

Primary Outcomes (4)

  • Change in coordination at the shoulder and elbow measured by joint independence after arm training assessed start of training, discharge and at follow up.

    kinematic measure of coordination between the shoulder and elbow joint

    baseline, 4 weeks, 8 weeks

  • Change in quality of arm motion measured by smoothness at the start of arm training, at 4week, and 8 weeks.

    kinematic assessment of arm motion measured by average velocity decided by maximum velocity

    baseline, 4 weeks, 8 weeks

  • Change in motor impairment of the arm measured by Fugl-Meyer Assessment (FMA) at the start of training, discharge, and follow up.

    performance based assessment of underlying motor impairment of the affected shoulder, elbow, hand after stroke

    baseline, 4 weeks, 8 weeks

  • Change in motor impairment and functional ability of the arm measured by the Wolf Motor Function Test (WMFT) at start of training, discharge, and follow up.

    performance based assessment of underlying motor impairment and function of the affected arm after stroke

    baseline, 4 weeks, 8 weeks

Study Arms (2)

External Focus (EF)

EXPERIMENTAL

Participants received arm training using the InMotion2 robot under external focus practice conditions and instructions. Participants practiced arm reaching by playing a simple video game. EF instructions: "Focus on moving the yellow ball on the screen in a smooth, straight line at a constant speed"; "Move the yellow ball toward the blinking red/orange light"; and "Hit the center of the target and try not to overshoot the target"

Behavioral: upper arm training on the InMotion 2 shoulder robot

Internal Focus (IF)

EXPERIMENTAL

Participants received arm training using the InMotion2 robot without the video game interface. Participants were instructed to think about how they were moving their arm while completing the arm training tasks. IF instructions: "think about how you're moving your arm"; "push your arm away from you"; "pull your arm toward you"; "move your arm to the right/left"

Behavioral: upper arm training on the InMotion 2 shoulder robot

Interventions

Both groups practiced shoulder and elbow exercises on a robotic arm device under an external focus or internal focus practice condition. Practiced arm reaching in a clock-like design to facilitate horizontal shoulder flexion, extension, abduction, adduction. 12 sessions--3 times a week for 4 weeks

External Focus (EF)Internal Focus (IF)

Eligibility Criteria

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

You may qualify if:

  • diagnosis of stroke \> 6 months
  • moderate to severe arm impairment
  • intact visual scanning and spatial orientation of the affected arm
  • functional cognitive status
  • medically stable

You may not qualify if:

  • concurrent occupational or physical therapy for the arm
  • joint contractures at the wrist, forearm, elbow, or shoulder
  • moderate to severe spasticity at the elbow or shoulder
  • presence of other neurological conditions
  • botulinum toxin injection in the affected arm \< 3 months prior
  • score of 0/5 on manual muscle test at the elbow or shoulder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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
  • Wulf G, Shea C, Lewthwaite R. Motor skill learning and performance: a review of influential factors. Med Educ. 2010 Jan;44(1):75-84. doi: 10.1111/j.1365-2923.2009.03421.x.

    PMID: 20078758BACKGROUND
  • 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
  • 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
  • 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
  • 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.

MeSH Terms

Conditions

StrokeParesis

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 26, 2016

First Posted

September 7, 2016

Study Start

May 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

September 7, 2016

Record last verified: 2016-08