Robotics For Rehabilitation Therapy: Functional Versus Individual Joint Training

Not Applicable

Completed

• Conditions: Cerebrovascular Accident
• Interventions: Device: Functional/ Multi-joints activities; Device: Individual Joint Training

• Registration Number: NCT01050231
• Lead Sponsor: University of California, Irvine

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2008-02-21
• Study First Submitted QC: 2010-01-13
• Study First Posted: 2010-01-15
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Results First Submitted: 2016-10-25
• Results First Submitted QC: 2021-02-24
• Status Verified: 2021-03
• Results First Posted: 2021-03-18
• Last Update Submitted: 2021-03-23
• Last Update Posted: 2021-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Robotic group (Type II)	Individual Joint Training	Type II Robotic Therapy (Individual joints first) Participants in this group will participate in individual joint training with the BONES robot first, followed by functional/task-oriented multi-joint training with the BONES robot. A one-week break was provided between interventions.
Robotic group (Type I)	Individual Joint Training	Type I Robotic Therapy (Functional activities first) Participants in this group will participate in functional/task-oriented multi-joint training with the BONES robot first, followed by individual joint training with the BONES robot. A one-week break was provided between interventions.
Robotic group (Type I)	Functional/ Multi-joints activities	Type I Robotic Therapy (Functional activities first) Participants in this group will participate in functional/task-oriented multi-joint training with the BONES robot first, followed by individual joint training with the BONES robot. A one-week break was provided between interventions.
Robotic group (Type II)	Functional/ Multi-joints activities	Type II Robotic Therapy (Individual joints first) Participants in this group will participate in individual joint training with the BONES robot first, followed by functional/task-oriented multi-joint training with the BONES robot. A one-week break was provided between interventions.

Primary Outcome Measures

Name	Time	Method
Box & Blocks Test	Baseline, Post first intervention at 5 weeks, post second intervention at 11 weeks, and 3-month after the completion of the second intervention.	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.

Trial Locations

Locations (1)

University of California, Irvine; 🇺🇸 Irvine, California, United States