FINGER Robot Therapy Study

NCT02048826 | Completed Results

• 1 other identifier: HS#2008-6432
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebrovascular Accident

Keywords

stroke

Outcome Measures

Primary Outcomes (1)

• 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.

  From baseline to 1-month post therapy

Secondary Outcomes (2)

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

  From baseline to 1-month post therapy

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

  From baseline to 1-month post therapy

Study Arms (2)

FINGER I

EXPERIMENTAL

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

Device: FINGER I; Device: FINGER II

FINGER II

EXPERIMENTAL

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

Device: FINGER I; Device: FINGER II

Interventions

FINGER I DEVICE

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

FINGER I; FINGER II

FINGER II DEVICE

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

FINGER I; FINGER II

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California, Irvine

Irvine, California, 92697, United States

Location

Related Publications (1)

• 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.

  PMID: 30728310 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Prof. David Reinkensmeyer
• Organization: University of California at Irvine

dreinken@uci.edu

949-824-5218

Study Officials

• David Reinkensmeyer, PhD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anatomy and Neurobiology

Study Record Dates

• First Submitted: January 27, 2014
• First Posted: January 29, 2014
• Study Start: November 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: February 1, 2016
• Last Updated: March 25, 2021
• Results First Posted: March 25, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)