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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02890446
Other study ID # #1311014488
Secondary ID
Status Completed
Phase N/A
First received August 26, 2016
Last updated August 31, 2016
Start date May 2014
Est. completion date November 2015

Study information

Verified date August 2016
Source New York Presbyterian Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Participants were randomized to one of two treatment groups and received upper arm reaching training on the InMotion 2 shoulder robot (12 hourly sessions over four weeks). The external focus group received instructions specifically to pay attention to the task goal--hitting targets on the video game, while the internal focus group was instructed to pay attention to the movement of their arm motions (video game monitor was turned off). Both groups practiced the same arm reaching pattern and were matched for level of arm impairment and training dosage.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date November 2015
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
upper arm training on the InMotion 2 shoulder robot
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

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
New York Presbyterian Hospital New York University

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
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