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Fast Arm Motor Skill Training (FAST)

Primary Purpose

Cerebrovascular Stroke

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fast intervention
Active Monitoring
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebrovascular Stroke focused on measuring Stroke, Physical therapy, neurorehabilitation, motor function, neuroplasticity, neuroimaging, MRI, TDI, Hemiparesis, occupational therapy, patient focused, motor learning, motor control, skill acquisition, skill training, motor recovery, task-oriented training, task-specific training, arm function, upper extremity, arm therapy, physical rehabilitation, arm rehabilitation

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Casa Colina Hospital and Centers for HealthcareRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Speed-biased complex motor skill training

Accuracy-biased complex motor skill training

Arm Description

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. .

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.

Outcomes

Primary Outcome Measures

Change in arm reaching movement time.
Average movement time for 30 planar reaching movements to target arrayed on a planar workspace.
Change in movement smoothness
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 in speed Accuracy Trade-off
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 in arm reaching movement time.
Average movement time for 30 planar reaching movements to target arrayed on a planar workspace.
Change in movement smoothness
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 in speed Accuracy Trade-off
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.

Secondary Outcome Measures

Change in Action Research Arm Test (ARAT)
The ARAT assess specific changes in limb function among individuals who sustained a stroke.
Change in Upper Extremity Fugl-Meyer (UEFM)
A test of motor function for the arm that is most affected by the stroke.
Change in Box and Block test score (BBT)
The Box and Block Test (BBT) measures unilateral gross manual dexterity.
Change in Action Research Arm Test (ARAT)
The ARAT assess specific changes in limb function among individuals who sustained a stroke.
Change in Upper Extremity Fugl-Meyer (UEFM)
A test of motor function for the arm that is most affected by the stroke.
Change in Box and Block test score (BBT)
The Box and Block Test (BBT) measures unilateral gross manual dexterity.

Full Information

First Posted
July 2, 2021
Last Updated
August 20, 2021
Sponsor
University of Southern California
Collaborators
Casa Colina Hospital and Centers for Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT05013762
Brief Title
Fast Arm Motor Skill Training
Acronym
FAST
Official Title
Fast Training Promotes Recovery of Arm Movements Post-stroke Via Cerebellar-mediated Anticipatory Feedforward Control
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 15, 2021 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
Collaborators
Casa Colina Hospital and Centers for Healthcare

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Every year, almost 800,000 people experience a stroke in the United States, which lead to upper-limb impairments, making recovery of motor function a priority in stroke rehabilitation. 1) The primary objective of this study is to determine whether fast arm movement training on a tracking task ("Speed-training"), in chronic stroke survivors with mild to moderate paresis, will generalize to improve arm function better than dose-equivalent accuracy training on the same task. 2) study the effect of intensive arm training on the recovery of anticipatory feedforward control. 3) Determine the involvement of cerebellar-cortical circuits in the recovery of arm movements due to speed training.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Stroke
Keywords
Stroke, Physical therapy, neurorehabilitation, motor function, neuroplasticity, neuroimaging, MRI, TDI, Hemiparesis, occupational therapy, patient focused, motor learning, motor control, skill acquisition, skill training, motor recovery, task-oriented training, task-specific training, arm function, upper extremity, arm therapy, physical rehabilitation, arm rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Assessments will be done by a blinded and standardized clinical researcher
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Speed-biased complex motor skill training
Arm Type
Active Comparator
Arm Description
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. .
Arm Title
Accuracy-biased complex motor skill training
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Fast intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Active Monitoring
Intervention Description
This is an observation-only group. The training received in this group will be dose equivalent to the active group.
Primary Outcome Measure Information:
Title
Change in arm reaching movement time.
Description
Average movement time for 30 planar reaching movements to target arrayed on a planar workspace.
Time Frame
Change from baseline to 3 days post-intervention
Title
Change in movement smoothness
Description
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.
Time Frame
Change from baseline to 3 days post-intervention
Title
Change in speed Accuracy Trade-off
Description
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.
Time Frame
Change from baseline to 3 days post-intervention
Title
Change in arm reaching movement time.
Description
Average movement time for 30 planar reaching movements to target arrayed on a planar workspace.
Time Frame
Change from baseline to 1 month post-intervention
Title
Change in movement smoothness
Description
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.
Time Frame
Change from baseline to 1 month post-intervention
Title
Change in speed Accuracy Trade-off
Description
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.
Time Frame
Change from baseline to 1 month post-intervention
Secondary Outcome Measure Information:
Title
Change in Action Research Arm Test (ARAT)
Description
The ARAT assess specific changes in limb function among individuals who sustained a stroke.
Time Frame
Change from baseline to 3 days post-intervention
Title
Change in Upper Extremity Fugl-Meyer (UEFM)
Description
A test of motor function for the arm that is most affected by the stroke.
Time Frame
Change from baseline to 3 days post-intervention
Title
Change in Box and Block test score (BBT)
Description
The Box and Block Test (BBT) measures unilateral gross manual dexterity.
Time Frame
Change from baseline to 3 days post-intervention
Title
Change in Action Research Arm Test (ARAT)
Description
The ARAT assess specific changes in limb function among individuals who sustained a stroke.
Time Frame
Change from baseline to 1 month post-intervention
Title
Change in Upper Extremity Fugl-Meyer (UEFM)
Description
A test of motor function for the arm that is most affected by the stroke.
Time Frame
Change from baseline to 1 month post-intervention
Title
Change in Box and Block test score (BBT)
Description
The Box and Block Test (BBT) measures unilateral gross manual dexterity.
Time Frame
Change from baseline to 1 month post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yannick Darmon
Phone
6195818500
Email
darmon@usc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Carolee Winstein
Email
winstein@pt.usc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas Schweighofer, PhD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
Casa Colina Hospital and Centers for Healthcare
City
Pomona
State/Province
California
ZIP/Postal Code
91769
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Rosario
Phone
909-596-7733
Ext
2220
Email
erosario@casacolina.org
First Name & Middle Initial & Last Name & Degree
Niko Fullmer
Email
NFullmer@casacolina.org

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27447365
Citation
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.
Results Reference
background
PubMed Identifier
31164067
Citation
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.
Results Reference
background
PubMed Identifier
26405046
Citation
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.
Results Reference
background
PubMed Identifier
29127826
Citation
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.
Results Reference
background
PubMed Identifier
3488093
Citation
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.
Results Reference
background
PubMed Identifier
1486143
Citation
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.
Results Reference
background
PubMed Identifier
10561408
Citation
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.
Results Reference
background
PubMed Identifier
30355628
Citation
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.
Results Reference
background

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Fast Arm Motor Skill Training

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