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FINGER Robot Therapy Study

Primary Purpose

Cerebrovascular Accident

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

FINGER I

FINGER II

About this trial

This is an interventional treatment trial for Cerebrovascular Accident focused on measuring stroke

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 18 to 80 years of age
Have history of stroke affecting the arm, at least 6 months prior to enrollment
have arm and/or hand weakness as measured on a standard clinical scale
do not have active major psychological problems, or problems affecting the stroke-affected arm or hand besides the stroke
do not have active major brain disease other than the stroke
have absence of pain in the stroke-affected arm and hand

Exclusion Criteria:

severe stiffness of the arm or hand as measured on a standard clinical scale
severe problems speaking or understanding speech as measured on a standard clinical scale
severe reduced level of consciousness
severe loss ability to sense movement of your limbs as measured on a standard clinical scale
currently pregnant
difficulty in understanding or complying with the instructions given by the researcher
inability to perform the experimental task that will be studied
increased pain with movement of the stroke-affected arm or hand

Exclusion criteria that will prevent subjects from participating in the MRI:

Subjects having any implanted metal such as metallic splinters, metallic surgical clips, prosthetic heart valves, pacemakers, neuro-stimulation devices, orthodontic work that contains ferromagnetic materials,
Subjects whose occupation or activities may cause accidental lodging of ferromagnetic materials, or that may have imbedded metal fragments from military activities, unless cleared by a screening head CT scan
Subjects with tattoo(s) presenting metallic or ferromagnetic color ingredients or with facial make-up
Subjects who have claustrophobia
Subjects who are currently pregnant or breastfeeding.

Sites / Locations

University of California, Irvine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

FINGER I

FINGER II

Arm Description

Subjects participate in 3 weeks of exercising with the experimental device: FINGER robot with first setting at a minimum of 3 days per week, 1 hour per day with the exercise program

Subjects participate in 3 weeks of exercising with the experimental device: FINGER robot with a second setting at a minimum of 3 days per week, 1 hour per day with the exercise program

Outcomes

Primary Outcome Measures

Motor and Strength Outcome Measure Using Box and Block Test Measured in Units of Blocks Placed

The primary endpoint was the change in Box and Blocks score, which measures how many blocks a subject can pick up and place in a box in 60 seconds, from baseline to 1-month post-therapy. The higher the scores, the better arm and hand function indicated.

Secondary Outcome Measures

Motor and Strength Measure Using Action Research Arm Test Measured as a Score

We compared the change in Action Research Arm Test (ARAT) scores from the baseline evaluation to 1-month post-therapy evaluation. The ARAT is a 57-point scale, 0 being the minimum scoreand 57 being the maximum score, that measures upper extremity function, coordination, and dexterity. The higher scores indicate a better outcome.

Motor, Strength and Sensory Using Fugl-Meyer Test Measured as a Score

The primary outcome measure was the change in Upper Extremity Fugl-Meyer score on a scale of 0 to 66 at one-month post-therapy. The higher the scores, the better arm and hand function indicated.

Full Information

NCT ID

NCT02048826

First Posted

January 27, 2014

Last Updated

March 23, 2021

Sponsor

University of California, Irvine

1. Study Identification

Unique Protocol Identification Number

NCT02048826

Brief Title

FINGER Robot Therapy Study

Official Title

Study of Influence of Timing on Motor Learning

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

November 2013 (undefined)

Primary Completion Date

May 2015 (Actual)

Study Completion Date

February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, Irvine

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine the effectiveness of training hand movement using FINGER robot after stroke. FINGER is a robot that measures finger movements and allows users to play computer games using those movements.

Detailed Description

Robotic devices can be used to retrain movement after stroke. However, it is unclear how best to assist in movement. Providing physical assistance may improve the flow of proprioceptive information to the nervous system, which may help a person relearn to move a limb. On the other hand, assisting movement with a robot may cause a person to "slack", not trying as hard during therapy. This study will test the effect of different levels of assistance on recovery of finger function during robot-assisted therapy after stroke.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cerebrovascular Accident

Keywords

stroke

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

FINGER I

Arm Type

Experimental

Arm Description

Subjects participate in 3 weeks of exercising with the experimental device: FINGER robot with first setting at a minimum of 3 days per week, 1 hour per day with the exercise program

Arm Title

FINGER II

Arm Type

Experimental

Arm Description

Subjects participate in 3 weeks of exercising with the experimental device: FINGER robot with a second setting at a minimum of 3 days per week, 1 hour per day with the exercise program

Intervention Type

Device

Intervention Name(s)

FINGER I

Intervention Description

FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting I

Intervention Type

Device

Intervention Name(s)

FINGER II

Intervention Description

FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting II

Primary Outcome Measure Information:

Title

Motor and Strength Outcome Measure Using Box and Block Test Measured in Units of Blocks Placed

Description

Time Frame

From baseline to 1-month post therapy

Secondary Outcome Measure Information:

Title

Motor and Strength Measure Using Action Research Arm Test Measured as a Score

Description

Time Frame

From baseline to 1-month post therapy

Title

Motor, Strength and Sensory Using Fugl-Meyer Test Measured as a Score

Description

The primary outcome measure was the change in Upper Extremity Fugl-Meyer score on a scale of 0 to 66 at one-month post-therapy. The higher the scores, the better arm and hand function indicated.

Time Frame

From baseline to 1-month post therapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18 to 80 years of age Have history of stroke affecting the arm, at least 6 months prior to enrollment have arm and/or hand weakness as measured on a standard clinical scale do not have active major psychological problems, or problems affecting the stroke-affected arm or hand besides the stroke do not have active major brain disease other than the stroke have absence of pain in the stroke-affected arm and hand Exclusion Criteria: severe stiffness of the arm or hand as measured on a standard clinical scale severe problems speaking or understanding speech as measured on a standard clinical scale severe reduced level of consciousness severe loss ability to sense movement of your limbs as measured on a standard clinical scale currently pregnant difficulty in understanding or complying with the instructions given by the researcher inability to perform the experimental task that will be studied increased pain with movement of the stroke-affected arm or hand Exclusion criteria that will prevent subjects from participating in the MRI: Subjects having any implanted metal such as metallic splinters, metallic surgical clips, prosthetic heart valves, pacemakers, neuro-stimulation devices, orthodontic work that contains ferromagnetic materials, Subjects whose occupation or activities may cause accidental lodging of ferromagnetic materials, or that may have imbedded metal fragments from military activities, unless cleared by a screening head CT scan Subjects with tattoo(s) presenting metallic or ferromagnetic color ingredients or with facial make-up Subjects who have claustrophobia Subjects who are currently pregnant or breastfeeding.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Reinkensmeyer, PhD

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

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30728310

Citation

Ingemanson ML, Rowe JR, Chan V, Wolbrecht ET, Reinkensmeyer DJ, Cramer SC. Somatosensory system integrity explains differences in treatment response after stroke. Neurology. 2019 Mar 5;92(10):e1098-e1108. doi: 10.1212/WNL.0000000000007041. Epub 2019 Feb 6.

Results Reference

derived

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FINGER Robot Therapy Study

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