NCT05013762

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2021

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

July 2, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 19, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2023

Completed
Last Updated

May 21, 2024

Status Verified

May 1, 2024

Enrollment Period

2.2 years

First QC Date

July 2, 2021

Last Update Submit

May 19, 2024

Conditions

Keywords

StrokePhysical therapyneurorehabilitationmotor functionneuroplasticityneuroimagingMRITDIHemiparesisoccupational therapypatient focusedmotor learningmotor controlskill acquisitionskill trainingmotor recoverytask-oriented trainingtask-specific trainingarm functionupper extremityarm therapyphysical rehabilitationarm rehabilitation

Outcome Measures

Primary Outcomes (6)

  • Change in arm reaching movement time.

    Average movement time for 30 planar reaching movements to target arrayed on a planar workspace.

    Change from baseline to 3 days post-intervention

  • 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 from baseline to 3 days post-intervention

  • 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 from baseline to 3 days post-intervention

  • Change in arm reaching movement time.

    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

    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

    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 Outcomes (6)

  • Change in Action Research Arm Test (ARAT)

    Change from baseline to 3 days post-intervention

  • Change in Upper Extremity Fugl-Meyer (UEFM)

    Change from baseline to 3 days post-intervention

  • Change in Box and Block test score (BBT)

    Change from baseline to 3 days post-intervention

  • Change in Action Research Arm Test (ARAT)

    Change from baseline to 1 month post-intervention

  • Change in Upper Extremity Fugl-Meyer (UEFM)

    Change from baseline to 1 month post-intervention

  • +1 more secondary outcomes

Study Arms (2)

Speed-biased complex motor skill training

ACTIVE COMPARATOR

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. .

Behavioral: Fast intervention

Accuracy-biased complex motor skill training

OTHER

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.

Behavioral: Active Monitoring

Interventions

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.

Speed-biased complex motor skill training

This is an observation-only group. The training received in this group will be dose equivalent to the active group.

Accuracy-biased complex motor skill training

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Casa Colina Hospital and Centers for Healthcare

Pomona, California, 91769, United States

Location

Related Publications (9)

  • 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.

    PMID: 27447365BACKGROUND
  • 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.

    PMID: 31164067BACKGROUND
  • 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.

    PMID: 26405046BACKGROUND
  • 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.

    PMID: 29127826BACKGROUND
  • 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.

    PMID: 3488093BACKGROUND
  • 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.

    PMID: 1486143BACKGROUND
  • 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.

    PMID: 10561408BACKGROUND
  • 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.

    PMID: 30355628BACKGROUND
  • Darmon Y, Kantak S, Cone H, Fullmer N, Ouellette D, Winstein C, Rosario ER, Schweighofer N. Speed-Biased Training Temporarily Improves Motor Performance of the Paretic Arm Compared to Accuracy-Biased Training in Chronic Stroke Survivors: The Phase 1 FAST Randomized Clinical Trial. Neurorehabil Neural Repair. 2025 Jul;39(7):542-554. doi: 10.1177/15459683251331582. Epub 2025 May 10.

MeSH Terms

Conditions

StrokeParesis

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nicolas Schweighofer, PhD

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Assessments will be done by a blinded and standardized clinical researcher
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Biokinesiology and Physical Therapy

Study Record Dates

First Submitted

July 2, 2021

First Posted

August 19, 2021

Study Start

June 15, 2021

Primary Completion

September 1, 2023

Study Completion

November 27, 2023

Last Updated

May 21, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations