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Clinical Trials/NCT04818073
NCT04818073
Active, not recruiting
Not Applicable

Determinants of the Effectiveness of Robot-assisted Hand Movement Training

University of California, Irvine1 site in 1 country60 target enrollmentMay 6, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke, Ischemic
Sponsor
University of California, Irvine
Enrollment
60
Locations
1
Primary Endpoint
Box and Blocks Test
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

The investigators would like to investigate the effectiveness of somatosensory training for robot-assisted hand motor rehabilitation after stroke.

Detailed Description

From previous studies, the investigators learned that stroke survivors with impaired finger proprioception did not achieve as large a functional benefit from robotic finger training. For this study, the investigators would like to determine if and the extent of finger proprioception can be improved through targeted robotic proprioceptive training combined with robotic finger movement training. The investigators would also include imagining studies via Electroencephalogram (EEG) and other baseline predictors to provide insight to determine who responds best to proprioceptive training.

Registry
clinicaltrials.gov
Start Date
May 6, 2022
End Date
August 31, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

David Reinkensmeyer

Professor

University of California, Irvine

Eligibility Criteria

Inclusion Criteria

  • Age 18 to 85 years
  • Suffered from a single ischemic stroke (radiologically confirmed) at least 6-months prior to enrollment
  • An ability to score at least 3 blocks on the Box and Block Test

Exclusion Criteria

  • A substantial decrease in alertness, language reception or attention
  • Pregnant or lactating
  • Advanced liver, kidney, cardiac or pulmonary disease
  • Plan to alter any current participation in other rehabilitation therapy in the time period of the study
  • A terminal medical diagnosis consistent with survival \< 1 year
  • Coexistent major neurological disease
  • Coexistent major psychiatric disease
  • A history of significant alcohol or drug abuse in the prior 3 years
  • Current enrollment in another study related to stroke or stroke recovery
  • Any other medical contraindication to participation in this study evaluated by our team physician.

Outcomes

Primary Outcomes

Box and Blocks Test

Time Frame: From baseline to 1-month post intervention

We compare the change of Box and Block Test scores from baseline evaluation to 1-month post intervention. Participants are instructed to move as many blocks as possible, one at a time, from one compartment in a box to a second compartment over a divider for a period of 60 seconds; each block that is moved is counted, and multiple blocks moved at the same time are counted as a single block. The higher scores indicate a better outcome.

Secondary Outcomes

  • Motor Activity Log(From baseline to 1-month post intervention)
  • Changes in finger proprioception measured using the Crisscross Assessment.(From baseline to 1-month post intervention)
  • Fugl-Meyer Motor Assessment of the Upper Extremity(From baseline to 1-month post intervention)

Study Sites (1)

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