Amputation of Upper LimbEarly Phase 1NCT02666859
Virtual Reality Prosthetic Training and Rehabilitation
A Early Phase 1 study testing Virtual Reality in people with Amputation of Upper Limb, run by University of South Florida at 1 site in United States.
Trial summary
The proposed project is to develop an effective prosthetic training and rehabilitation regimen, with the use of virtual reality, to return patients to the highest level of independence and functioning possible. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Amputation of Upper Limb
- What is being tested?
- Virtual Reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Jun 2019
- Phase
- Early Phase 1
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients with unilateral transhumeral or transradial amputation
- uses body-powered or myoelectric prosthetic device.
- free of any health aliment that would impair physical function
- must not have any injuries or surgeries on the affected limb within the past 90 days.
- Subjects ,just be able to perform activities of daily living without assistance
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Virtual Reality to Enhance Upper Limb Prosthetic Training and Rehabilitation
The proposed project is to develop an effective prosthetic training and rehabilitation regimen, with the use of virtual reality, to return patients to the highest level of independence and functioning possible. The Computer Assisted Rehabilitation Environment (CAREN) system (Motek Medical, Netherlands) will be used to immerse patients into real life situations while providing real time visual feedback of their motion to improve the training and rehabilitation of upper limb prosthetic users.
Read the detailed description
The subjects will be asked to participate in two 1-2 hour sessions to test the range of motion (ROM), activities of daily living ( ADL) and return to duty tasks (RTD) tasks with and without the use of virtual reality. All amputee subjects will be required to wear their same preferred prosthetic device for all sessions. The ROM tasks include, elbow flexion/extension, forearm pronation/supination, shoulder flexion/extension, shoulder abduction/adduction, shoulder rotation, torso flexion/extension, torso lateral flexion, and torso rotation. The ADL tasks would include a series of tasks to encompass typical actives one would encounter on a daily basis such as, drinking from a cup, bilateral and unilateral lift tasks, and a reach and grasp test. The RTD tasks would include a series of simple tasks service members typically perform in their daily work routine such as donning and doffing a jacket and helmet, packing and unpacking a rucksack, and carrying a weapon.
The subjects will be asked to complete each task three times. Prior to performing a task, when participating in the virtual reality session, the task will be demonstrated on the virtual screen with an animated model. The motion of the animated model will be determined by previously collected data to accurately predict the correct motion for each individual. An avatar of the subject will then be shown on the screen to display the real time motion. The reflective markers that were strategically placed on the subject will be connected to the corresponding joint on the virtual avatar to accurately animate the real time motion of the subject on the virtual screen. The demonstrated model will be shown simultaneously with the real time avatar to show the accuracy of the subject's performance in relation to the individualized predicted optimized motion. This will provide instant visual feedback to the subject.
- Conditions
- Amputation of Upper Limb
- Being tested
- Virtual Reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
During this intervention, the subjects will be immersed in a virtual reality system called the Computer Assisted Rehabilitation Environment (CAREN) system to complete the tasks.
| Study group | Role | What they receive |
|---|---|---|
| Unilateral Transradial Amputation | Experimental | This group includes people with a unilateral transradial amputation. Potential subjects must use a body-powered or myoelectric prosthetic device. This group will be exposed to virtual reality therapy and non-virtual reality therapy. Receives: Device: Virtual Reality |
| Unilateral Transhumeral Amputation | Experimental | This group includes people with a unilateral transhumeral amputation. Potential subjects must use a body-powered or myoelectric prosthetic device. This group will be exposed to virtual reality therapy and non-virtual reality therapy. Receives: Device: Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Joint Angle Range of Motion
Using a motion capture system, joint angle measurements will be taken throughout the sessions while the subject completes the tasks.
Measured: 2 hours
Secondary outcomes (1)
Movement Symmetry
Using a motion capture system and the joint angle measurements, the movement symmetry of the arms will be calculated.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amputation of Upper LimbStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Virtual Reality Prosthetic Training
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command, Telemedicine & Advanced Technology Research Center
- Responsible party
- Principal investigator, Stephanie L. Carey, University of South Florida
- Investigators
- Ashley Knight, M.S. BME, Principal investigator, University of South FloridaStephanie Carey, Ph.D. BME, Study director, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02666859
- Sponsor's protocol ID
- Pro00016934
- Status last verified
- Jul 2019
- First submitted
- 12 Jan 2016
- Last updated
- 12 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Virtual Reality to Enhance Upper Limb Prosthetic Training and Rehabilitation
- ClinicalTrials.gov ID
- NCT02666859
- Acronym / sponsor ID
- Pro00016934
- Conditions
- Amputation of Upper Limb
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command, Telemedicine & Advanced Technology Research Center
- Study start
- Jan 2016 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 28 Jan 2016 (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.
The proposed project is to develop an effective prosthetic training and rehabilitation regimen, with the use of virtual reality, to return patients to the highest level of independence and functioning possible. The Computer Assisted Rehabilitation Environment (CAREN) system (Motek Medical, Netherlands) will be used to immerse patients into real life situations while providing real time visual feedback of their motion to improve the training and rehabilitation of upper limb prosthetic users.
Detailed description
The subjects will be asked to participate in two 1-2 hour sessions to test the range of motion (ROM), activities of daily living ( ADL) and return to duty tasks (RTD) tasks with and without the use of virtual reality. All amputee subjects will be required to wear their same preferred prosthetic device for all sessions. The ROM tasks include, elbow flexion/extension, forearm pronation/supination, shoulder flexion/extension, shoulder abduction/adduction, shoulder rotation, torso flexion/extension, torso lateral flexion, and torso rotation. The ADL tasks would include a series of tasks to encompass typical actives one would encounter on a daily basis such as, drinking from a cup, bilateral and unilateral lift tasks, and a reach and grasp test. The RTD tasks would include a series of simple tasks service members typically perform in their daily work routine such as donning and doffing a jacket and helmet, packing and unpacking a rucksack, and carrying a weapon.
The subjects will be asked to complete each task three times. Prior to performing a task, when participating in the virtual reality session, the task will be demonstrated on the virtual screen with an animated model. The motion of the animated model will be determined by previously collected data to accurately predict the correct motion for each individual. An avatar of the subject will then be shown on the screen to display the real time motion. The reflective markers that were strategically placed on the subject will be connected to the corresponding joint on the virtual avatar to accurately animate the real time motion of the subject on the virtual screen. The demonstrated model will be shown simultaneously with the real time avatar to show the accuracy of the subject's performance in relation to the individualized predicted optimized motion. This will provide instant visual feedback to the subject.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Virtual Reality Prosthetic Training
| Arm | Type | Receives |
|---|---|---|
| Unilateral Transradial Amputation | Experimental | Device: Virtual RealityThis group includes people with a unilateral transradial amputation. Potential subjects must use a body-powered or myoelectric prosthetic device. This group will be exposed to virtual reality therapy and non-virtual reality therapy. |
| Unilateral Transhumeral Amputation | Experimental | Device: Virtual RealityThis group includes people with a unilateral transhumeral amputation. Potential subjects must use a body-powered or myoelectric prosthetic device. This group will be exposed to virtual reality therapy and non-virtual reality therapy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients with unilateral transhumeral or transradial amputation
- uses body-powered or myoelectric prosthetic device.
- free of any health aliment that would impair physical function
- must not have any injuries or surgeries on the affected limb within the past 90 days.
- Subjects ,just be able to perform activities of daily living without assistance
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual RealityDuring this intervention, the subjects will be immersed in a virtual reality system called the Computer Assisted Rehabilitation Environment (CAREN) system to complete the tasks. | Device | Unilateral Transhumeral Amputation, Unilateral Transradial Amputation |
Primary outcome
Joint Angle Range of Motion
Time frame: 2 hours
Using a motion capture system, joint angle measurements will be taken throughout the sessions while the subject completes the tasks.
1 secondary outcome
Movement Symmetry
Time frame: 2 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 12 Jul 2019.
Related trials for Amputation of Upper Limb
Recruiting
Hemocoll, Avitene, or Bone Wax for Cancellous Bone Bleeding After Single-Ray Amputation
Hemostasis, Surgical Blood Loss
Recruiting
Bio Leg: Advancing Mobility (BAM)
Amputation of Lower Limb Above Knee, Amputee
Recruiting
Cross-Over Study Evaluating the TASKA GEN2 Myoelectric Hand Prosthesis
Upper Limb Amputation, Transradial Amputation
Not yet recruiting
Determining the Effects of Ischemic Conditioning and Neuromuscular Electrical Stimulation on Overall Function After Lower Limb Amputation
Lower Limb Amputation Above Knee, Below Knee Amputation
Recruiting
Optimize Pattern Recognition Control of Powered Upper Limb Prosthesis
Prosthesis User, Prosthesis
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.
Ashley Knight, M.S. BME principal investigator
University of South Florida
Stephanie Carey, Ph.D. BME study director
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Virtual Reality in people with Amputation of Upper Limb, 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 5 inclusion and 0 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 12 Jul 2019. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Joint Angle Range of Motion (time frame: 2 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 12 Jul 2019.