- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02890446
The Effects of Attentional Focus on Arm Training in Stroke
A Randomized Control Trial on the Effects of Attentional Focus on Motor Training of the Upper Extremity Using Robotics With Individuals After Chronic Stroke
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: External Focus (EF)
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" |
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 |
Experimental: Internal Focus (IF)
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" |
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in coordination at the shoulder and elbow measured by joint independence after arm training assessed start of training, discharge and at follow up.
Time Frame: baseline, 4 weeks, 8 weeks
|
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.
Time Frame: baseline, 4 weeks, 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.
Time Frame: baseline, 4 weeks, 8 weeks
|
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.
Time Frame: baseline, 4 weeks, 8 weeks
|
performance based assessment of underlying motor impairment and function of the affected arm after stroke
|
baseline, 4 weeks, 8 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- #1311014488
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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