Fast Arm Motor Skill Training (FAST)

May 19, 2024 updated by: Carolee Winstein, University of Southern California

Fast Training Promotes Recovery of Arm Movements Post-stroke Via Cerebellar-mediated Anticipatory Feedforward Control

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.

Study Overview

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

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Pomona, California, United States, 91769
        • Casa Colina Hospital and Centers for Healthcare

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

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

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
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. .
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.
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.

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
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
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.
Change from baseline to 3 days post-intervention
Change in Upper Extremity Fugl-Meyer (UEFM)
Time Frame: Change from baseline to 3 days post-intervention
A test of motor function for the arm that is most affected by the stroke.
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

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

Investigators

  • Principal Investigator: Nicolas Schweighofer, PhD, University of Southern California

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.

General Publications

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 (Actual)

June 15, 2021

Primary Completion (Actual)

September 1, 2023

Study Completion (Actual)

November 27, 2023

Study Registration Dates

First Submitted

July 2, 2021

First Submitted That Met QC Criteria

August 17, 2021

First Posted (Actual)

August 19, 2021

Study Record Updates

Last Update Posted (Actual)

May 21, 2024

Last Update Submitted That Met QC Criteria

May 19, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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