FINGER Robot Therapy Study

NCT ID: NCT02048826

Last Updated: 2021-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2016-02-29

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.

Conditions

Cerebrovascular Accident

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

FINGER I

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

Group Type: EXPERIMENTAL

FINGER I

Intervention Type: 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 II

Intervention Type: 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 II

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

Group Type: EXPERIMENTAL

FINGER I

Intervention Type: 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 II

Intervention Type: 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

Interventions

FINGER I

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

FINGER II

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

Intervention Type: DEVICE

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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

David Reinkensmeyer

Professor of Anatomy and Neurobiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Reinkensmeyer, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

University of California, Irvine

Irvine, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30728310 (View on PubMed)

Other Identifiers

HS#2008-6432

Identifier Type: -

Identifier Source: org_study_id