Robotics For Rehabilitation Therapy: Functional Versus Individual Joint Training

NCT ID: NCT01050231

Last Updated: 2021-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2012-01-31

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.

Conditions

Cerebrovascular Accident

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Robotic group (Type I)

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.

Group Type: EXPERIMENTAL

Functional/ Multi-joints activities

Intervention Type: DEVICE

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

Intervention Type: DEVICE

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.

Robotic group (Type II)

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.

Group Type: ACTIVE_COMPARATOR

Functional/ Multi-joints activities

Intervention Type: DEVICE

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

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 73 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

David Reinkensmeyer

Professor of Mechanical and Aerospace Engineering

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David J Reinkensmeyer, Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

University of California, Irvine

Irvine, California, United States

Countries

United States

References

Milot MH, Spencer SJ, Chan V, Allington JP, Klein J, Chou C, Bobrow JE, Cramer SC, Reinkensmeyer DJ. A crossover pilot study evaluating the functional outcomes of two different types of robotic movement training in chronic stroke survivors using the arm exoskeleton BONES. J Neuroeng Rehabil. 2013 Dec 19;10:112. doi: 10.1186/1743-0003-10-112.

Reference Type: DERIVED

PMID: 24354476 (View on PubMed)

Other Identifiers

HS#2005-4506

Identifier Type: -

Identifier Source: org_study_id