- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05013762
Fast Arm Motor Skill Training (FAST)
Fast Training Promotes Recovery of Arm Movements Post-stroke Via Cerebellar-mediated Anticipatory Feedforward Control
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
About 65% of stroke survivors experience long-term limitations in upper extremity (UE) functions. In particular, limitations in arm reaching movements are prominent and correlate strongly with patients' impairment levels. Because activities of daily living often involve the UEs, retraining reach and grasp skills is critical for return to a full quality-of-life. Yet, the training parameters required for effective rehabilitation of UE function are not known. Recent evidence suggests that high-speed movements during training are effective at improving arm movements in individuals with chronic stroke. Hence, fast movements generating large errors, would promote the restoration of the feedforward controllers and therefore improves arm movements and UE functions in individuals with chronic stroke. Because the cerebellum is involved in learning feedforward controllers from motor errors, the improvements would be proportional to the integrity of the cerebellar-cortical networks.
A double-blind quasi-randomized controlled study will be carried out in chronic post-stroke survivors. Participants will be assigned to either the speed-bias training group or a dose equivalent accuracy-bias training group (control) and will receive 4 days of training over a 1week period by a trained Occupational or physical therapist. Behavioral, EMG, and MRI data will be acquired within two weeks before, 3 days post, and one month after intervention.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Pomona, California, United States, 91769
- Casa Colina Hospital and Centers for Healthcare
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- At least 6 months following an ischemic supratentorial stroke
- At least 21 years of age
- Exhibit residual capability to move the paretic UE (Upper Extremity Fugl- Meyer motor score >20/66)
- Able to follow a 2-step command (8th item on the MMSE test)
- Able to perform an unassisted arm reach movement of 25 cm ahead of the body within 5 seconds with trunk restraint
- Exhibit no greater than mild/moderate spasticity as assessed with a Modified Ashworth Score < 3
Exclusion Criteria:
- any neurologic diagnoses other than stroke
- peripheral movement restrictions, such as neuropathy
- orthopedic disorders affecting the paretic UE
- severe pain or sensory/proprioceptive impairment in the more affected UE
- visual neglect (more than 4% of lines left uncrossed on Albert's test).
- had a stroke directly affecting the cerebellum
- any contra-indications to MRI scanning
- mostly resolved impairments with an Upper Extremity Fugl- Meyer motor score >58/66
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 |
|---|---|
|
Active Comparator: Speed-biased complex motor skill training
Participants will perform 400 complex movements per day over 4 days over a one-week period.
The task requires participants to navigate their hand through a "track" projected on the surface of a table with a width of 5cm.
Participants receive adaptive score based on their movement time. .
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This intervention is based on recent body of evidence that high-speed movements during training are effective at improving arm movements in individuals with chronic stroke.Participants will be rewarded for movements performed within a short amount of time.
|
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Other: Accuracy-biased complex motor skill training
The accuracy-biased group receives a dose equivalent intervention with a emphasize on accuracy.
The width of the track projected on the table is narrower (less than 2cm) and the adaptive score received are based on their accuracy to say within the boundary of the track.
|
This is an observation-only group.
The training received in this group will be dose equivalent to the active group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in arm reaching movement time.
Time Frame: Change from baseline to 3 days post-intervention
|
Average movement time for 30 planar reaching movements to target arrayed on a planar workspace.
|
Change from baseline to 3 days post-intervention
|
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Change in movement smoothness
Time Frame: Change from baseline to 3 days post-intervention
|
Average movement smoothness for 30 planar reaching movements to target arrayed on a planar workspace.
Smoothness is computed by number of peaks in hand tangential velocity profiles of arm-reaching movements.
|
Change from baseline to 3 days post-intervention
|
|
Change in speed Accuracy Trade-off
Time Frame: Change from baseline to 3 days post-intervention
|
The investigators will compute the "Fitts" slope between "index of difficulty" of reaching movements and movement time, for targets at 3 distances and of 4 diameters.
|
Change from baseline to 3 days post-intervention
|
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Change in arm reaching movement time.
Time Frame: Change from baseline to 1 month post-intervention
|
Average movement time for 30 planar reaching movements to target arrayed on a planar workspace.
|
Change from baseline to 1 month post-intervention
|
|
Change in movement smoothness
Time Frame: Change from baseline to 1 month post-intervention
|
Average movement smoothness for 30 planar reaching movements to target arrayed on a planar workspace.
Smoothness is computed by number of peaks in hand tangential velocity profiles of arm-reaching movements.
|
Change from baseline to 1 month post-intervention
|
|
Change in speed Accuracy Trade-off
Time Frame: Change from baseline to 1 month post-intervention
|
The investigators will compute the "Fitts" slope between "index of difficulty" of reaching movements and movement time, for targets at 3 distances and of 4 diameters.
|
Change from baseline to 1 month post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Action Research Arm Test (ARAT)
Time Frame: Change from baseline to 3 days post-intervention
|
The ARAT assess specific changes in limb function among individuals who sustained a stroke.
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Change from baseline to 3 days post-intervention
|
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Change in Upper Extremity Fugl-Meyer (UEFM)
Time Frame: Change from baseline to 3 days post-intervention
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A test of motor function for the arm that is most affected by the stroke.
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Change from baseline to 3 days post-intervention
|
|
Change in Box and Block test score (BBT)
Time Frame: Change from baseline to 3 days post-intervention
|
The Box and Block Test (BBT) measures unilateral gross manual dexterity.
|
Change from baseline to 3 days post-intervention
|
|
Change in Action Research Arm Test (ARAT)
Time Frame: Change from baseline to 1 month post-intervention
|
The ARAT assess specific changes in limb function among individuals who sustained a stroke.
|
Change from baseline to 1 month post-intervention
|
|
Change in Upper Extremity Fugl-Meyer (UEFM)
Time Frame: Change from baseline to 1 month post-intervention
|
A test of motor function for the arm that is most affected by the stroke.
|
Change from baseline to 1 month post-intervention
|
|
Change in Box and Block test score (BBT)
Time Frame: Change from baseline to 1 month post-intervention
|
The Box and Block Test (BBT) measures unilateral gross manual dexterity.
|
Change from baseline to 1 month post-intervention
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Nicolas Schweighofer, PhD, University of Southern California
Publications and helpful links
General Publications
- Winstein C, Kim B, Kim S, Martinez C, Schweighofer N. Dosage Matters. Stroke. 2019 Jul;50(7):1831-1837. doi: 10.1161/STROKEAHA.118.023603. Epub 2019 Jun 5.
- Lang CE, Strube MJ, Bland MD, Waddell KJ, Cherry-Allen KM, Nudo RJ, Dromerick AW, Birkenmeier RL. Dose response of task-specific upper limb training in people at least 6 months poststroke: A phase II, single-blind, randomized, controlled trial. Ann Neurol. 2016 Sep;80(3):342-54. doi: 10.1002/ana.24734. Epub 2016 Aug 16.
- Park H, Kim S, Winstein CJ, Gordon J, Schweighofer N. Short-Duration and Intensive Training Improves Long-Term Reaching Performance in Individuals With Chronic Stroke. Neurorehabil Neural Repair. 2016 Jul;30(6):551-61. doi: 10.1177/1545968315606990. Epub 2015 Sep 24.
- Kantak S, McGrath R, Zahedi N, Luchmee D. Behavioral and neurophysiological mechanisms underlying motor skill learning in patients with post-stroke hemiparesis. Clin Neurophysiol. 2018 Jan;129(1):1-12. doi: 10.1016/j.clinph.2017.10.010. Epub 2017 Nov 8.
- Pantano P, Baron JC, Samson Y, Bousser MG, Derouesne C, Comar D. Crossed cerebellar diaschisis. Further studies. Brain. 1986 Aug;109 ( Pt 4):677-94. doi: 10.1093/brain/109.4.677.
- Kawato M, Gomi H. A computational model of four regions of the cerebellum based on feedback-error learning. Biol Cybern. 1992;68(2):95-103. doi: 10.1007/BF00201431.
- Gribble PL, Ostry DJ. Compensation for interaction torques during single- and multijoint limb movement. J Neurophysiol. 1999 Nov;82(5):2310-26. doi: 10.1152/jn.1999.82.5.2310.
- Maeda RS, Cluff T, Gribble PL, Pruszynski JA. Feedforward and Feedback Control Share an Internal Model of the Arm's Dynamics. J Neurosci. 2018 Dec 5;38(49):10505-10514. doi: 10.1523/JNEUROSCI.1709-18.2018. Epub 2018 Oct 24.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- MRI
- Stroke
- neuroimaging
- Physical therapy
- neuroplasticity
- occupational therapy
- motor learning
- Hemiparesis
- neurorehabilitation
- motor control
- upper extremity
- motor function
- task-specific training
- motor recovery
- physical rehabilitation
- arm function
- patient focused
- skill acquisition
- skill training
- arm therapy
- arm rehabilitation
- task-oriented training
- TDI
Additional Relevant MeSH Terms
Other Study ID Numbers
- HS-CG-20-00023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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