Spinal Cord InjuryHRINCT01652352
Experimental Evaluation of Wheelchair-Mounted Robotic Arms
An observational study of Spinal Cord Injury and Cerebral Palsy, run by University of South Florida at 1 site in United States.
Trial summary
Researchers from the University of South Florida's Rehabilitation Engineering program are looking for volunteers to participate in a research study for experimental evaluation of wheelchair-mounted robotic arms (WMRAs). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury, Cerebral Palsy, Multiple Sclerosis
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Jul 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Candidates will be recruited from University of South Florida facilities and through channels of normal operation of the Center for Assistive and Rehabilitation Robotic Technologies laboratory, its group members, and students. Included candidate sources are primary and specialist care facilities in the Tampa Bay area, affiliates of USF, CARRT, and the College of Engineering, contacts of said organizations, and the general community.
Who may be able to join
- Be between the ages of 18 and 60
- Have an injury or condition resulting in power wheelchair dependence
- Consent to disclose pertinent medical information for purposes of determining level of mobility
- Possess physical dexterity and capacity to operate the following devices:
- 16 button numeric keypad - dimensions: 3inch by 3inch square
- Touch screen tablet PC - dimensions: 15inch (diagonal)
Show all 15Show fewer
- SpaceNavigator 3D joystick - movements: push, pull, lift, press, twist
- Standard joystick - movements: push, pull
- Chin joystick - movements: push, pull
- Possess capacity to understand the objective of each task, including but not limited to turning on a light switch, opening a cabinet, moving a cup from a table top to the participant's mouth, and opening a door
- Demonstrate the ability to understand, or become familiar with the basic function of both the input device and WMRA
- Spend up to four (4) hours, at one time, in the laboratory located at:
- Rehabilitation Robotics and Prosthetics Testbed (RRT) 13335 Laurel Drive Tampa, FL 33620
- Consent to having a test platform temporarily attached to the participant's wheelchair. The attachment will use soft nylon straps and in no way inflict damage to the participant's property
- Sign an informed consent form
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Rehabilitation Robotics and Prosthetics Testbed
Tampa, Florida, 33620
About this study
Official title: HRI: Maximizing Manipulation of Persons With Disabilities Using a Smart Wheelchair-Mounted Robotic System
Researchers from the University of South Florida's Rehabilitation Engineering program are looking for volunteers to participate in a research study for experimental evaluation of wheelchair-mounted robotic arms (WMRAs).
Participants will operate commercially available and developmental WMRAs in a physical test environment. The study will serve to identify desirable design features of WMRAs and input devices so that future production systems may further increase the quality of life of potential users.
The study will also promote both the justification of prescribing WMRAs to enhance quality of life through the proposed standard testing method, and awareness for the emerging assistive robotics industry.
Read the detailed description
Individuals with injuries or conditions resulting in both upper and lower body disabilities who are power wheelchair-bound are of key interest.
The purpose of this study is to experimentally evaluate up to six wheelchair mounted robotic arms (WMRAs). The goal is to quantitatively compare each device. In order to compare each device, patients will be asked to operate one of up to six wheelchair mounted robotic arms at a time. With each WMRA, patients will be asked to perform a series of up to four activities of daily living. patients will be presented with a survey at the conclusion of each task test. The survey is designed to quantitatively rank each WMRA's performance. The time to complete each task with each arm will also be recorded.
Patients will be asked some questions such as age, occupation, disability and/or physical limitations, and wheelchair use.
Patients will be asked to disclose pertinent medical information to determine their level of mobility. Then the patients and the research team will know whether or not they should be in the study.
If they take part in this study, patients will be asked to use a series of devices to control each of the six WMRAs to complete the following tasks:
- Open cabinets of varying heights
- Open drawers of varying heights
- Operate mock sink fixtures
- Operate mock light switches
- Plug into and out of mock electrical outlets
- Open personnel door
- Move objects on a table top
- Move objects on a book shelf
- Move a cup from a table top to the participant's mouth
- Perform any of the previous tasks under additional cognitive load * Additional cognitive load may include but is not limited to carrying on a conversation while attempting to perform a given task
Patients will be asked to spend about four hours in this study, which will be completed in one session at the Rehabilitation Robotics and Prosthetics Testbed at the University of South Florida. Break and refreshment time will be available during setup and installation time for each of up to six WMRAs. It is anticipated that twenty people will take part in this study at USF.
Participants who take part in this study may find quality of life benefits as a result of becoming familiar with WMRA assistive devices. Participants may find using a WMRA helpful in performing activities of daily living, though participants will not be given any of the WMRAs for personal use. The research study is directed at comparing and contrasting commercially available and developmental WMRAs. The study will also help to increase awareness of WMRAs and possibly help develop an assistive manipulator industry in the United States.
- Conditions
- Spinal Cord Injury, Cerebral Palsy, Multiple Sclerosis
- Keywords
- Disabled, Disability, Power wheelchair, Wheelchair, Wheelchair mounted robotic arm, WMRA, Assistive, Assistive robot, Assistive robotics, Rehabilitation robot, Rehabilitation engineering, Rehabilitation robotics
- Medical subject headings
- Spinal Cord Injuries, Cerebral Palsy, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with Disability | Power wheelchair-bound individuals with conditions which affect upper and lower body mobility, strength, or dexterity. Such conditions may include but are not limited to spinal cord injury, Multiple Sclerosis, Cerebral Palsy, or other conditions which affect overall mobility. | |
| Able-Bodied Individuals | Those who possess no condition or injury resulting in loss of mobility. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy - Ease of Use
In order to quantitatively evaluate the efficacy of each of up to six WMRAs, a survey will be presented to the participant at the conclusion of the final testing trial of each task of interest. The participant will be asked to rate the ease of performing the given task with the given WMRA and input device on a number ranking scale. The survey should be completed at the conclusion of testing trials for each task (the participant will be asked to perform up to four individual tasks).
Measured: Efficacy in performing a given task with a given wheelchair- mounted robotic arm will be recorded after three (3) repetitions of the task have been completed. Testing should take no longer than 4 hours.
Secondary outcomes (1)
Time of Completion
The participant will be asked to perform a given task three (3) times. These will be testing trials where time of performance will be recorded. The time of performance will begin when the participant initializes the task. The time of performance will stop when the task has been completed. At the end of each testing trial, the task must be reset
Measured: Time of completion will be recorded after each testing trial. Testing should take no longer than 4 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2012 (estimated)
- Study startAug 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. National Science Foundation
- Responsible party
- Sponsor
- Investigators
- Rajiv Dubey, Ph.D., Principal investigator, Major Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01652352
- Sponsor's protocol ID
- 105880
- Other IDs
- 0713560
- Acronym
- HRI
- Status last verified
- Jul 2012
- First submitted
- 13 Sep 2010
- Last updated
- 30 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HRI: Maximizing Manipulation of Persons With Disabilities Using a Smart Wheelchair-Mounted Robotic System
- ClinicalTrials.gov ID
- NCT01652352
- Acronym / sponsor ID
- HRI / 105880
- Conditions
- Spinal Cord Injury, Cerebral Palsy, Multiple Sclerosis
- Keywords
- Disabled, Disability, Power wheelchair, Wheelchair, Wheelchair mounted robotic arm, WMRA, Assistive, Assistive robot
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- U.S. National Science Foundation
- Study start
- Aug 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 30 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Researchers from the University of South Florida's Rehabilitation Engineering program are looking for volunteers to participate in a research study for experimental evaluation of wheelchair-mounted robotic arms (WMRAs).
Participants will operate commercially available and developmental WMRAs in a physical test environment. The study will serve to identify desirable design features of WMRAs and input devices so that future production systems may further increase the quality of life of potential users.
The study will also promote both the justification of prescribing WMRAs to enhance quality of life through the proposed standard testing method, and awareness for the emerging assistive robotics industry.
Detailed description
Individuals with injuries or conditions resulting in both upper and lower body disabilities who are power wheelchair-bound are of key interest.
The purpose of this study is to experimentally evaluate up to six wheelchair mounted robotic arms (WMRAs). The goal is to quantitatively compare each device. In order to compare each device, patients will be asked to operate one of up to six wheelchair mounted robotic arms at a time. With each WMRA, patients will be asked to perform a series of up to four activities of daily living. patients will be presented with a survey at the conclusion of each task test. The survey is designed to quantitatively rank each WMRA's performance. The time to complete each task with each arm will also be recorded.
Patients will be asked some questions such as age, occupation, disability and/or physical limitations, and wheelchair use.
Patients will be asked to disclose pertinent medical information to determine their level of mobility. Then the patients and the research team will know whether or not they should be in the study.
If they take part in this study, patients will be asked to use a series of devices to control each of the six WMRAs to complete the following tasks:
- Open cabinets of varying heights
- Open drawers of varying heights
- Operate mock sink fixtures
- Operate mock light switches
- Plug into and out of mock electrical outlets
- Open personnel door
- Move objects on a table top
- Move objects on a book shelf
- Move a cup from a table top to the participant's mouth
- Perform any of the previous tasks under additional cognitive load * Additional cognitive load may include but is not limited to carrying on a conversation while attempting to perform a given task
Patients will be asked to spend about four hours in this study, which will be completed in one session at the Rehabilitation Robotics and Prosthetics Testbed at the University of South Florida. Break and refreshment time will be available during setup and installation time for each of up to six WMRAs. It is anticipated that twenty people will take part in this study at USF.
Participants who take part in this study may find quality of life benefits as a result of becoming familiar with WMRA assistive devices. Participants may find using a WMRA helpful in performing activities of daily living, though participants will not be given any of the WMRAs for personal use. The research study is directed at comparing and contrasting commercially available and developmental WMRAs. The study will also help to increase awareness of WMRAs and possibly help develop an assistive manipulator industry in the United States.
Study design
- Observational model
- Case-control
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individuals with Disability | – | –Power wheelchair-bound individuals with conditions which affect upper and lower body mobility, strength, or dexterity. Such conditions may include but are not limited to spinal cord injury, Multiple Sclerosis, Cerebral Palsy, or other conditions which affect overall mobility. |
| Able-Bodied Individuals | – | –Those who possess no condition or injury resulting in loss of mobility. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Candidates will be recruited from University of South Florida facilities and through channels of normal operation of the Center for Assistive and Rehabilitation Robotic Technologies laboratory, its group members, and students. Included candidate sources are primary and specialist care facilities in the Tampa Bay area, affiliates of USF, CARRT, and the College of Engineering, contacts of said organizations, and the general community.
Key inclusion criteria (15 listed)
- Be between the ages of 18 and 60
- Have an injury or condition resulting in power wheelchair dependence
- Consent to disclose pertinent medical information for purposes of determining level of mobility
- Possess physical dexterity and capacity to operate the following devices:
- Possess capacity to understand the objective of each task, including but not limited to turning on a light switch, opening a cabinet, moving a cup from a table top to the participant's mouth, and opening a door
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Efficacy - Ease of Use
Time frame: Efficacy in performing a given task with a given wheelchair- mounted robotic arm will be recorded after three (3) repetitions of the task have been completed. Testing should take no longer than 4 hours.
In order to quantitatively evaluate the efficacy of each of up to six WMRAs, a survey will be presented to the participant at the conclusion of the final testing trial of each task of interest. The participant will be asked to rate the ease of performing the given task with the given WMRA and input device on a number ranking scale. The survey should be completed at the conclusion of testing trials for each task (the participant will be asked to perform up to four individual tasks).
1 secondary outcome
Time of Completion
Time frame: Time of completion will be recorded after each testing trial. Testing should take no longer than 4 hours.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2012.
- Center for Assistive and Rehabilitation Robotics TechnologiesLink provided by the sponsor.
- USF College of EngineeringLink provided by the sponsor.
- USF Department of Mechanical EngineeringLink provided by the sponsor.
- Study Facebook GroupLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rajiv Dubey, Ph.D. principal investigator
Major Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injury and Cerebral Palsy, run by University of South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy - Ease of Use (time frame: Efficacy in performing a given task with a given wheelchair- mounted robotic arm will be recorded after three (3) repetitions of the task have been completed. Testing should take no longer than 4 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2012; AzTrials last refreshed its copy on 6 Nov 2026.