Robotics For Rehabilitation Therapy: Functional Versus Individual Joint Training

NCT01050231 | Completed Results

• 1 other identifier: HS#2005-4506
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebrovascular Accident

Keywords

stroke; cerebrovascular accident; robot

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Robotic group (Type I)

EXPERIMENTAL

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.

Device: Functional/ Multi-joints activities; Device: Individual Joint Training

Robotic group (Type II)

ACTIVE COMPARATOR

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.

Device: Functional/ Multi-joints activities; Device: Individual Joint Training

Interventions

Functional/ Multi-joints activities 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.

Robotic group (Type I); Robotic group (Type II)

Individual Joint Training 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 I); Robotic group (Type II)

Eligibility Criteria

• Age: 18 Years - 73 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 73
• Sustained single stroke at least three months previously
• Minimal to moderate lost motor control of the arm after stroke

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California, Irvine

Irvine, California, 92697, United States

Location

Related Publications (1)

• 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.

  PMID: 24354476 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: Dr David Reinkensmeyer
• Organization: University of California Irvine

dreinken@uci.edu

(949) 824-5218

Study Officials

• David J Reinkensmeyer, Ph.D

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Mechanical and Aerospace Engineering

Study Record Dates

• First Submitted: February 21, 2008
• First Posted: January 15, 2010
• Study Start: October 1, 2006
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: April 19, 2021
• Results First Posted: March 18, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)