StrokeNCT02890446
The Effects of Attentional Focus on Arm Training in Stroke
A study testing upper arm training on the InMotion 2 shoulder robot in people with Stroke, run by New York Presbyterian Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- upper arm training on the InMotion 2 shoulder robot
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- May 2014to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke
- Being tested
- upper arm training on the InMotion 2 shoulder robot
- Keywords
- attentional focus, upper extremity, hemiparesis, stroke
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
upper arm training on the InMotion 2 shoulder robotBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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" Receives: 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" Receives: Behavioral: upper arm training on the InMotion 2 shoulder robot |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: baseline, 4 weeks, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startMay 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York Presbyterian Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- New York University
- Responsible party
- Principal investigator, Grace Kim, New York Presbyterian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02890446
- Sponsor's protocol ID
- #1311014488
- Status last verified
- Aug 2016
- First submitted
- 26 Aug 2016
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24054892Wulf 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.
PubMed 20078758Fasoli 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.
PubMed 12125827Durham 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.
PubMed 23796803Wulf 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.
PubMed 11765737Kim 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.
PubMed 28652064
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial on the Effects of Attentional Focus on Motor Training of the Upper Extremity Using Robotics With Individuals After Chronic Stroke
- ClinicalTrials.gov ID
- NCT02890446
- Acronym / sponsor ID
- #1311014488
- Conditions
- Stroke
- Keywords
- attentional focus, upper extremity, hemiparesis, stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- New York Presbyterian HospitalUniversity, hospital or other
- Collaborators
- New York University
- Study start
- May 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 7 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| External Focus (EF) | Experimental | Behavioral: upper arm training on the InMotion 2 shoulder robotParticipants 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" |
| Internal Focus (IF) | Experimental | Behavioral: upper arm training on the InMotion 2 shoulder robotParticipants 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" |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| upper arm training on the InMotion 2 shoulder robotBoth 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 | Behavioural | External Focus (EF), Internal Focus (IF) |
Primary outcome
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2016.
- Background: PubMed 24054892Kal 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.
- Background: PubMed 20078758Wulf 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.
- Background: PubMed 12125827Fasoli 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.
- Background: PubMed 23796803Durham 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.
- Background: PubMed 11765737Wulf 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.
- Derived from this study: PubMed 28652064Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing upper arm training on the InMotion 2 shoulder robot in people with Stroke, run by New York Presbyterian Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02890446, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2016.