Back to resultsRobotics For Rehabilitation Therapy: Functional Versus Individual Joint Training
Primary Purpose
Cerebrovascular Accident
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Functional/ Multi-joints activities
Individual Joint Training
Sponsored by
About this trial
This is an interventional treatment trial for Cerebrovascular Accident focused on measuring stroke, cerebrovascular accident, robot
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
Sites / Locations
- University of California, Irvine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Robotic group (Type I)
Robotic group (Type II)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01050231
First Posted
February 21, 2008
Last Updated
March 23, 2021
Sponsor
University of California, Irvine
1. Study Identification
Unique Protocol Identification Number
NCT01050231
Brief Title
Robotics For Rehabilitation Therapy: Functional Versus Individual Joint Training
Official Title
Robotics For Rehabilitation Therapy: Functional Versus Individual Joint Training
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident
Keywords
stroke, cerebrovascular accident, robot
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Robotic group (Type I)
Arm Type
Experimental
Arm Description
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.
Arm Title
Robotic group (Type II)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Functional/ Multi-joints activities
Intervention Description
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
Intervention Name(s)
Individual Joint Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Box & Blocks Test
Description
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.
Time Frame
Baseline, Post first intervention at 5 weeks, post second intervention at 11 weeks, and 3-month after the completion of the second intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
73 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David J Reinkensmeyer, Ph.D
Organizational Affiliation
University of California, Irvine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24354476
Citation
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.
Results Reference
derived
Learn more about this trial
Robotics For Rehabilitation Therapy: Functional Versus Individual Joint Training
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