Determinants of the Effectiveness of Robot-assisted Hand Movement Training

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

Study Overview

• Status: Active, not recruiting
• Conditions: Stroke, Ischemic; Cerebrovascular Accident (CVA)
• Intervention / Treatment: Device: New FINGER

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92697
      • University of California Irvine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Participants with undergo new FINGER robotic training with no physical assistance 3 times a week for a period of 3 weeks.	Device: New FINGER; New FINGER exoskeleton is a robotic device that can provide assistance and resistance to thumb and finger movement
Experimental: Group B; Participants will undergo new FINGER robotic training with physical assistance 3 times a week for a period of 3 weeks.	Device: New FINGER; New FINGER exoskeleton is a robotic device that can provide assistance and resistance to thumb and finger movement
Experimental: Group C; Participants will undergo new FINGER robotic training with physical assistance and proprioceptive exercises 3 times a week for a period of 3 weeks.	Device: New FINGER; New FINGER exoskeleton is a robotic device that can provide assistance and resistance to thumb and finger movement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Box and Blocks Test	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.	From baseline to 1-month post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl-Meyer Motor Assessment of the Upper Extremity	We will measure the change of the Fugl-Meyer Motor Assessment scores from the baseline evaluation to 1-month post intervention. Fugl-Meyer is a 66-point scale measuring the movement pattern of upper extremities. The higher scores indicate a better outcome.	From baseline to 1-month post intervention
Motor Activity Log	We will measure the change of the Motor Activity Log (MAL) mean scores from the baseline evaluation to 1-month post intervention. The Motor Activity Log is a 30 questionnaire that collect subjective measure of an individual's real life functional upper limb performance. The higher scores indicate a better outcome.	From baseline to 1-month post intervention
Changes in finger proprioception measured using the Crisscross Assessment.	We will measure the change in finger proprioception scores from the baseline evaluation to 1-month post intervention. Finger proprioception is measured by using the FINGER Crisscross Assessment which we slowly move the index and middle fingers with the FINGER robot past each other without any visual input. We then ask study participants to press a key when they feel the fingers are overlapped. Finger proprioception is measured by the error which will be quantified as the mean magnitude of finger separation error at the metacarpal joint when the key is pressed. The lower scores indicate a better outcome.	From baseline to 1-month post intervention

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); University of Idaho
• Investigators: Principal Investigator: David Reinkensmeyer, Ph.D, University of California, Irvine

Publications and helpful links

General Publications

• Rowe JB, Chan V, Ingemanson ML, Cramer SC, Wolbrecht ET, Reinkensmeyer DJ. Robotic Assistance for Training Finger Movement Using a Hebbian Model: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2017 Aug;31(8):769-780. doi: 10.1177/1545968317721975.
• Ingemanson ML, Rowe JB, Chan V, Wolbrecht ET, Cramer SC, Reinkensmeyer DJ. Use of a robotic device to measure age-related decline in finger proprioception. Exp Brain Res. 2016 Jan;234(1):83-93. doi: 10.1007/s00221-015-4440-4. Epub 2015 Sep 16.

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2022
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: March 23, 2021
• First Submitted That Met QC Criteria: March 23, 2021
• First Posted (Actual): March 26, 2021

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 8, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Rehabilitation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: 476; 2R01HD062744-06 (U.S. NIH Grant/Contract)

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
• product manufactured in and exported from the U.S.: No