The Effects of Attentional Focus on Arm Training in Stroke

August 31, 2016 updated by: Grace Kim, New York Presbyterian Hospital

A Randomized Control Trial on the Effects of Attentional Focus on Motor Training of the Upper Extremity Using Robotics With Individuals After Chronic Stroke

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.

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

August 26, 2016

First Submitted That Met QC Criteria

August 31, 2016

First Posted (Estimate)

September 7, 2016

Study Record Updates

Last Update Posted (Estimate)

September 7, 2016

Last Update Submitted That Met QC Criteria

August 31, 2016

Last Verified

August 1, 2016

More Information

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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