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Determinants of the Effectiveness of Robot-assisted Hand Movement Training

Primary Purpose

Stroke, Ischemic, Cerebrovascular Accident (CVA)

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
New FINGER
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Ischemic focused on measuring Rehabilitation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California IrvineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group A

Group B

Group C

Arm Description

Participants with undergo new FINGER robotic training with no physical assistance 3 times a week for a period of 3 weeks.

Participants will undergo new FINGER robotic training with physical assistance 3 times a week for a period of 3 weeks.

Participants will undergo new FINGER robotic training with physical assistance and proprioceptive exercises 3 times a week for a period of 3 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
March 23, 2021
Last Updated
September 28, 2022
Sponsor
University of California, Irvine
Collaborators
University of Idaho, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT04818073
Brief Title
Determinants of the Effectiveness of Robot-assisted Hand Movement Training
Official Title
Determinants of the Effectiveness of Robot-assisted Hand Movement Training
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 6, 2022 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine
Collaborators
University of Idaho, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic, Cerebrovascular Accident (CVA)
Keywords
Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Randomized single-blinded
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Participants with undergo new FINGER robotic training with no physical assistance 3 times a week for a period of 3 weeks.
Arm Title
Group B
Arm Type
Experimental
Arm Description
Participants will undergo new FINGER robotic training with physical assistance 3 times a week for a period of 3 weeks.
Arm Title
Group C
Arm Type
Experimental
Arm Description
Participants will undergo new FINGER robotic training with physical assistance and proprioceptive exercises 3 times a week for a period of 3 weeks.
Intervention Type
Device
Intervention Name(s)
New FINGER
Intervention Description
New FINGER exoskeleton is a robotic device that can provide assistance and resistance to thumb and finger movement
Primary Outcome Measure Information:
Title
Box and Blocks Test
Description
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.
Time Frame
From baseline to 1-month post intervention
Secondary Outcome Measure Information:
Title
Fugl-Meyer Motor Assessment of the Upper Extremity
Description
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.
Time Frame
From baseline to 1-month post intervention
Title
Motor Activity Log
Description
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.
Time Frame
From baseline to 1-month post intervention
Title
Changes in finger proprioception measured using the Crisscross Assessment.
Description
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.
Time Frame
From baseline to 1-month post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vicky Chan, PT, DPT
Phone
(949) 824-8423
Email
vchan2@uci.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Reinkensmeyer, Ph.D
Organizational Affiliation
University of California, Irvine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vicky Chan, DPT
Phone
949-824-8423
Email
vchan2@uci.edu

12. IPD Sharing Statement

Citations:
PubMed Identifier
28803535
Citation
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.
Results Reference
background
PubMed Identifier
26378004
Citation
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.
Results Reference
background

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Determinants of the Effectiveness of Robot-assisted Hand Movement Training

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