Unilateral Transradial AmputationNCT02749643
Functional Outcome Measures With Vibrotactile Feedback to Prostheses
A study testing Vibrotactile feedback system in people with Unilateral Transradial Amputation, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Investigators wish to evaluate the effects of adding VTF to upper limb prostheses on functional outcome measures of upper limb prosthetic users. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Unilateral Transradial Amputation
- What is being tested?
- Vibrotactile feedback system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2016to Feb 2018
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral transradial amputee
- Using a transradial myoelectric prosthesis
- Ability to follow simple instructions, understand and sign an informed consent form
- Normal or corrected eyesight
Who cannot join
- Elbow or wrist disarticulation or partial hand amputations
- Neuropathy or skin ulcers on the amputated limb
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Adding Vibrotactile Feedback to Prostheses on Functional Outcome Measures of Transradial Amputation Prosthetic Users
Investigators wish to evaluate the effects of adding VTF to upper limb prostheses on functional outcome measures of upper limb prosthetic users.
Read the detailed description
Investigators will perform three experiments:
- Investigators will add vibrotactile feedback to prosthetic users during the execution of a standardized functional test and performance of simple grasping tasks, with a disruption to the normal visual feedback, and examine whether their performance and arm kinematics are improved with tactile feedback;
- Investigators will examine the effects of adding the feedback to a prosthesis on the performance and visual attention during a dual task assignment in prosthetic users, and
- Investigators will provide prosthetic users with the feedback, to use it at their natural surroundings for a week, and study the reported activity and satisfaction levels.
- Conditions
- Unilateral Transradial Amputation
- Being tested
- Vibrotactile feedback system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibrotactile feedback systemDevice
| Study group | Role | What they receive |
|---|---|---|
| Vibrotactile feedback | Experimental | Vibrotactile system - comprises of force sensors, attached to the fingertips of the prosthetic hand, and a set of 8 vibration actuators attached to a fabric arm cuff. When the subject applies force on the sensors with his prosthetic hand, he receives a vibration on the skin of his arm. The sensors and actuators are connected to an electronic control board, which transforms the resistance from the sensors to an electric signal that activates the vibration actuators. Receives: Device: Vibrotactile feedback system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Orthotics and Prosthetics User Survey-Upper Extremity Functional Status
A subjective questionnaire concerning the ability to perform daily tasks. The score ranges from 23 to 115.
Measured: 2 weeks
Secondary outcomes (3)
Modified Box & Blocks test
This test is aimed to assess unilateral gross manual dexterity. The test comprises of a two-compartment box and 16 cube blocks.The subject is instructed to transport the blocks as possible over the partition into the opposite compartment. The time in seconds is measured.
Measured: 2 weeks
Time to complete dual tasking test
The time needed to complete grasping tasks while playing a simple computer game with the other hand is measured in seconds.
Measured: 2 weeks
Activity
In order to record the actual use of the prosthesis in the natural environment of the subject, a wireless activity monitor that can be easily attached to the prosthesis will be used. The output measure of the activity monitor are "activity counts".
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Unilateral Transradial AmputationStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Collaborators
- Tel Aviv University
- Responsible party
- Principal investigator, Isabella Shvartz, Hadassah Medical Organization
- Investigators
- Sigal Portnoy, PhD, Study director, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02749643
- Sponsor's protocol ID
- VTF- HMO-CTIL
- Status last verified
- Jun 2018
- First submitted
- 13 Apr 2016
- Last updated
- 27 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Clemente F, D'Alonzo M, Controzzi M, Edin BB, Cipriani C. Non-Invasive, Temporally Discrete Feedback of Object Contact and Release Improves Grasp Control of Closed-Loop Myoelectric Transradial Prostheses. IEEE Trans Neural Syst Rehabil Eng. 2016 Dec;24(12):1314-1322. doi: 10.1109/TNSRE.2015.2500586. Epub 2015 Nov 13.
PubMed 26584497Raveh E, Portnoy S, Friedman J. Myoelectric Prosthesis Users Improve Performance Time and Accuracy Using Vibrotactile Feedback When Visual Feedback Is Disturbed. Arch Phys Med Rehabil. 2018 Nov;99(11):2263-2270. doi: 10.1016/j.apmr.2018.05.019. Epub 2018 Jun 20.
PubMed 29935153
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Adding Vibrotactile Feedback to Prostheses on Functional Outcome Measures of Transradial Amputation Prosthetic Users
- ClinicalTrials.gov ID
- NCT02749643
- Acronym / sponsor ID
- VTF- HMO-CTIL
- Conditions
- Unilateral Transradial Amputation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Collaborators
- Tel Aviv University
- Study start
- Apr 2016
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 25 Apr 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.
Investigators wish to evaluate the effects of adding VTF to upper limb prostheses on functional outcome measures of upper limb prosthetic users.
Detailed description
Investigators will perform three experiments:
- Investigators will add vibrotactile feedback to prosthetic users during the execution of a standardized functional test and performance of simple grasping tasks, with a disruption to the normal visual feedback, and examine whether their performance and arm kinematics are improved with tactile feedback;
- Investigators will examine the effects of adding the feedback to a prosthesis on the performance and visual attention during a dual task assignment in prosthetic users, and
- Investigators will provide prosthetic users with the feedback, to use it at their natural surroundings for a week, and study the reported activity and satisfaction levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vibrotactile feedback | Experimental | Device: Vibrotactile feedback systemVibrotactile system - comprises of force sensors, attached to the fingertips of the prosthetic hand, and a set of 8 vibration actuators attached to a fabric arm cuff. When the subject applies force on the sensors with his prosthetic hand, he receives a vibration on the skin of his arm. The sensors and actuators are connected to an electronic control board, which transforms the resistance from the sensors to an electric signal that activates the vibration actuators. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Unilateral transradial amputee
- Using a transradial myoelectric prosthesis
- Ability to follow simple instructions, understand and sign an informed consent form
- Normal or corrected eyesight
Key exclusion criteria (2 listed)
- Elbow or wrist disarticulation or partial hand amputations
- Neuropathy or skin ulcers on the amputated limb
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 |
|---|---|---|
| Vibrotactile feedback system | Device | Vibrotactile feedback |
Primary outcome
Orthotics and Prosthetics User Survey-Upper Extremity Functional Status
Time frame: 2 weeks
A subjective questionnaire concerning the ability to perform daily tasks. The score ranges from 23 to 115.
3 secondary outcomes
Modified Box & Blocks test
Time frame: 2 weeks
Time to complete dual tasking test
Time frame: 2 weeks
Activity
Time frame: 2 weeks
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 27 Jun 2018.
- Results publication: PubMed 26584497Clemente F, D'Alonzo M, Controzzi M, Edin BB, Cipriani C. Non-Invasive, Temporally Discrete Feedback of Object Contact and Release Improves Grasp Control of Closed-Loop Myoelectric Transradial Prostheses. IEEE Trans Neural Syst Rehabil Eng. 2016 Dec;24(12):1314-1322. doi: 10.1109/TNSRE.2015.2500586. Epub 2015 Nov 13.
- Derived from this study: PubMed 29935153Raveh E, Portnoy S, Friedman J. Myoelectric Prosthesis Users Improve Performance Time and Accuracy Using Vibrotactile Feedback When Visual Feedback Is Disturbed. Arch Phys Med Rehabil. 2018 Nov;99(11):2263-2270. doi: 10.1016/j.apmr.2018.05.019. Epub 2018 Jun 20.
- Individual participant dataSharing planned: Undecided
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.
Sigal Portnoy, PhD study director
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibrotactile feedback system in people with Unilateral Transradial Amputation, run by Hadassah Medical Organization at 1 site in Israel.
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 4 inclusion and 2 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 27 Jun 2018. 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 Israel. 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?
Orthotics and Prosthetics User Survey-Upper Extremity Functional Status (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02749643, which also lists 2 linked publications.
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 27 Jun 2018.