Robotics For Rehabilitation Therapy: Functional Versus Individual Joint Training

• Sponsor: University of California, Irvine (Other)
• Overall Status: Completed
• CT.gov ID: NCT01050231
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 63
• Patients Per Site Per Month: 0.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebrovascular Accident	Device: Functional/ Multi-joints activities; Device: Individual Joint Training	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Robotics For Rehabilitation Therapy: Functional Versus Individual Joint Training
• Study Start Date: Oct 1, 2006
• Actual Primary Completion Date: Jan 1, 2012
• Actual Study Completion Date: Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.; 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.
Active Comparator: 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.	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.; 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.

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 73 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, Irvine	Irvine	California	United States	92697

Sponsors and Collaborators

• University of California, Irvine

Investigators

• Principal Investigator: David J Reinkensmeyer, Ph.D, University of California, Irvine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: David Reinkensmeyer, Professor of Mechanical and Aerospace Engineering, University of California, Irvine
• ClinicalTrials.gov Identifier: NCT01050231
• Other Study ID Numbers: HS#2005-4506
• First Posted: Jan 15, 2010
• Last Update Posted: Apr 19, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by David Reinkensmeyer, Professor of Mechanical and Aerospace Engineering, University of California, Irvine: stroke; cerebrovascular accident; robot
• Additional relevant MeSH terms: Stroke

Study Results

Participant Flow

Arm/Group Title	Individual Joints and Functional Multi-joints Tasks	Functional Multi-joints Activities and Individual Joints
Arm/Group Description	Robotic group(Type I) Type II Robotic therapy (Individual joints only): Subjects participate in 11 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 as the patient play interactive computer games.	Robotic group (Type II) Type I Robotic Group (Functional activities and individual joints): Subjects participate in 11 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.
Period Title: Overall Study
STARTED	10	10
COMPLETED	10	10
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Type I Robotic Therapy (Functional Activities Then Individual Joint Exercises)	Type II Robotic Therapy (Individual Joints Exercises Then Functional Activities)	Total
Arm/Group Description	Robotic group (Type I) Type I Robotic Group (Functional activities and individual joints): Subjects participate in 11 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 involving multiple joints at the same time for the functional activities such as cleaning the window, driving a steering wheel, grocery shopping, etc; and then individual joint exercises focusing on one joint at a time with the individual joint exercises.	Robotic group (Type II) Type II Robotic therapy (Individual joints exercises then functional activities): Subjects participate in 11 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 as the patient perform individual joint exercises focusing on one joint at a time; and then functional activities like cleaning the window, driving a steering wheel, grocery shopping, etc for the functional activities.	Total of all reporting groups
Overall Participants	10	10	20
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	7 70%	9 90%	16 80%
>=65 years	3 30%	1 10%	4 20%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60 (7)	60 (7)	60 (7)
Sex: Female, Male (Count of Participants)
Female	6 60%	4 40%	10 50%
Male	4 40%	6 60%	10 50%
Region of Enrollment (participants) [Number]
United States	10 100%	10 100%	20 100%

Outcome Measures

1. Primary Outcome

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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Functional Multi-joint Training Then Individual Joint Training	Individual Joint Training Then Functional Multi-joint Training
Arm/Group 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 which focuses on functional multi-joint activities such as cleaning the windows, driving a steering wheel, grocery shopping, etc. Then, subjects performed individual joint exercises focusing on one joint at a time for another 4 weeks with 3 days per week and 1 hour per day with the robot-assisted exercise program.	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 which focuses on individual joint exercises, one joint at a time. Then, subjects performed the multi-joint functional training exercises for another 4 weeks with 3 days per week and 1 hour per day focusing on multi-joint activities such as cleaning the windows, driving a steering wheel, grocery shopping, etc.
Measure Participants	10	10
Baseline evaluation	25 (11)	36 (14)
Post 1st Intervention	29 (18)	42 (14)
Post 2nd Intervention	31 (11)	43 (13)
3-month follow up evaluation	28 (5)	46 (9)

Adverse Events

Arm/Group Title	Individual Joints		Functional Multi-Joint Activities
Arm/Group Description	Robotic group(Type I) Type II Robotic therapy (Individual joints only): Subjects participate 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. Then, after one-week of a rest break, all subjects will return to participate in another 4 weeks of training with BONES again, 3 days per week with 1 hour per day, focusing on multi-joint activities such as cleaning the windows, driving a steering wheel, grocery shopping, etc.		Robotic group (Type II) Type I Robotic Group (Functional Multi-joint activities): Subjects participate 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 multi-joint activities such as cleaning the windows, driving a steering wheel, grocery shopping, etc. Then, after a one-week rest break, all subjects will return to participate in another 4 weeks of training with BONES again, 3 days per week with 1 hour per day, focusing on individual joint exercises with one joint at a time.
All Cause Mortality
	Individual Joints		Functional Multi-Joint Activities
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Serious Adverse Events
	Individual Joints		Functional Multi-Joint Activities
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Individual Joints		Functional Multi-Joint Activities
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.