Robotics For Rehabilitation Therapy: Functional Versus Individual Joint Training

Cerebrovascular Accident Clinical Trial

Official title:

Robotics For Rehabilitation Therapy: Functional Versus Individual Joint Training

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01050231
• Other study ID #: HS#2005-4506
• Status: Completed
• Phase: N/A
• Start date: October 2006
• Est. completion date: January 2012

Study information

• Verified date: March 2021
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to develop an upper extremity robotic training system for use by people with stroke to practice arm and hand movement in the clinic.

Description:

Each year in the U.S. over 400,000 people survive a stroke and approximately 80% of acute stroke survivors lose arm and hand movement skills. Movement impairments are typically treated with intensive, hands-on physical and occupational therapy for several weeks after the initial brain injury. Unfortunately, due to economic pressure on the U.S. health care system, stroke patients are receiving less therapy and going home sooner. Our goal for this study is to develop an upper extremity robotic training system for both acute and chronic stroke population to improve movement ability with intensive and repetitive movement in the clinic without continuous supervision from a therapist.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 73 Years

Eligibility

Inclusion Criteria:

• Age between 18 and 73

• Sustained single stroke at least three months previously

• Minimal to moderate lost motor control of the arm after stroke

Exclusion Criteria:

• Concurrent severe medical problems

• Severe cognitive dysfunction

• Severe neglect or apraxia

• Severe visual deficits

• Significant subluxation of the shoulder

• Presence of severe elbow or wrist contracture

• Any metal implants or surgical clips or mechanical devices

• Metallic hardware on scalp region

• prior diagnosis of seizure and epilepsy

• severe migraine headache

• currently pregnant or lactating

• claustrophobic

• currently taking medication that lower seizure threshold

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Stroke

Intervention

Device:
• Functional/ Multi-joints activities
Subjects participated in 4 weeks of robotic training with the device: BONES (Biomimetic Orthosis Neurorehabilitation for Elbow and Shoulder), 3 days per week, 1 hour per day with the robotic exercise program focusing on functional tasks such as cleaning the windows, driving a steering wheel, grocery shopping, etc.
• Individual Joint Training
Subjects participated in 4 weeks of training with the robotic device BONES, 3 days per week, 1 hour per day with a robot-assisted exercise program. The robotic exoskeleton assists in arm and hand movements focusing on one joint at a time.

Locations

Country	Name	City	State
United States	University of California, Irvine	Irvine	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Box & Blocks Test	We measured the Box and Blocks Test scores at baseline evaluation, after each intervention, and at the 3-month follow up evaluation. 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.	Baseline, Post first intervention at 5 weeks, post second intervention at 11 weeks, and 3-month after the completion of the second intervention.