Upper Limb Amputation at the HandNCT04069793
Functional Importance of a Powered Multifunction Wrist Protocol
A study testing Commercially available device and Non FDA registered device in people with Upper Limb Amputation at the Hand and Upper Limb Amputation at the Wrist, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
The focus of this study is to conduct a clinical study in individuals with transradial amputations to compare function using a 1-DOF or 2-DOF wrist. All prostheses will be attached to a single DOF Otto Bock hand and controlled using a pattern recognition system equivalent to the Coapt system. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Upper Limb Amputation at the Hand, Upper Limb Amputation at the Wrist, Amputation
- What is being tested?
- Commercially available device and Non FDA registered device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2018to 19 Feb 2024
- 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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18-95
- A unilateral upper limb amputation or absence below the elbow
- English speaking
Who cannot join
- Significant new injury that would prevent use of a prosthesis: The ability to consistently wear a prosthesis and perform activities of daily living and specific performance tasks is necessary to evaluate the relative benefits of the interventions.
- Cognitive impairment sufficient to adversely affect understanding of or compliance with study requirements, ability to communicate experiences, or ability to give informed consent: The ability to understand and comply with requirements of the study is essential in order for the study to generate useable, reliable data. The ability to obtain relevant user feedback through questionnaires and informal discussion adds significant value to this study.
- Significant other comorbidity: Any other medical issues or injuries that would preclude completion of the study, use of the prostheses, or that would otherwise prevent acquisition of useable data by researchers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determining the Functional Importance of a Powered Multifunction Wrist
The focus of this study is to conduct a clinical study in individuals with transradial amputations to compare function using a 1-DOF or 2-DOF wrist. All prostheses will be attached to a single DOF Otto Bock hand and controlled using a pattern recognition system equivalent to the Coapt system. This study will enable the investigator to quantify the relative functional value of powered wrist flexion during both in-laboratory testing and home use. In addition, the investigators will address the effectiveness of different hand-wrist combinations to enhance patient-centered clinical decision making.
Read the detailed description
The primary objective of this project is to evaluate the functional importance of a multi function wrist compared to a single degree of freedom wrist. This will be accomplished through in laboratory testing and an 8-week home trial. The first aim will involve in-laboratory functional performance testing with a 1-DOF or a 2-DOF wrist and a one degree of freedom hand.
Changes in performance will be assessed with multiple outcome measures that include both quantitative and qualitative testing of prosthesis control and functional performance. The second aim will determine how a 2-DOF wrist impacts control and home use of a one degree of freedom hand. Subjects will compete an 8 week home based trial. Participants will be instructed to complete a written home log of activities and electronic logging usage data will also be collected for each experimental condition. The investigators hypothesize that adding a wrist flexion/extension module to a wrist rotation module and a single-DOF terminal device will provide significant improvements in function for transradial amputees.
- Conditions
- Upper Limb Amputation at the Hand, Upper Limb Amputation at the Wrist, Amputation, Amputation; Traumatic, Limb
- Being tested
- Commercially available device, Non FDA registered device
- Keywords
- Transradial Amputee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Commercially available deviceDevice
A commercially available and registered with the FDA prosthesis equipped with a powered single-degree of freedom wrist and powered hand.
Non FDA registered deviceDevice
An experimental, non FDA registered prosthesis equipped with a multi function wrist and a powered hand.
| Study group | Role | What they receive |
|---|---|---|
| Home Trial Condition A | Active comparator | Subject will use a pattern recognition controlled prosthesis that includes a powered wrist rotation, passive wrist flexion/extension, and a single DOF powered hand. Receives: Device: Commercially available device |
| Home Trial Condition B | Experimental | Subject will use at pattern recognition controlled prosthesis that includes a powered wrist rotation, powered flexion/extension and a single DOF powered hand. Receives: Device: Non FDA registered device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Academy of Prosthetics and Orthotics ULPOM committee toolkit of outcome measures to record change of prosthetic performance
Measuring the function of upper limb prostheses is challenging and requires multiple test formats. A toolkit of functional outcome tests recommend by the Academy of Prosthetics and Orthotics ULPOM committee will be used to measure functional effectiveness of prosthetic treatment will be used as the primary outcome measure. The outcome measures to evaluate prosthesis use includes both quantitative and qualitative testing of prosthesis control and functional performance.
Measured: Baseline and 8 weeks for Condition A; Baseline and 8 weeks for Condition B
Secondary outcomes (8)
SHAP: Southampton Hand Assessment Procedure; a clinically validated hand function test to assess the effectiveness of upper limb prostheses.
An objective test of unilateral hand function that can be used to evaluate functionality of passive, mechanical, or myoelectric hands without bias to type [31]. Movement of abstract objects (classified into six prehension patterns) and activities of daily living are timed by the subject. Scores are compared to a normalized, able-bodied control score of 100.
Measured: Baseline and 8 weeks for Condition A; Baseline and 8 weeks for Condition B
Modified Box and Blocks Test of Manual Dexterity
A timed test that evaluates gross manual dexterity. Small (1-inch) blocks are moved one at a time from one side of a box to the other over a wooden partition. The final score is the number of blocks transferred in 1 minute, typically averaged over three trials. For this test, only opening and closing of the terminal device is required, although subjects with transradial amputations do typically use compensatory movements. It is possible that a 2-DOF wrist may move inadvertently and impair performance on this task. As a result, we would view either an improvement or no change in this score to be a positive finding.
Measured: Baseline and 8 weeks for Condition A; Baseline and 8 weeks for Condition B
Jebsen-Taylor Hand Function Test
A standardized test of manual dexterity that evaluates hand function during performance of seven hand-related tasks using common items such as cards, cans, paper clips, and coins [32]. Subjects are evaluated by the time required to complete each task
Measured: Baseline and 8 weeks for Condition A; Baseline and 8 weeks for Condition B
Assessment of Capacity for Myoelectric Control (ACMC)
An observational assessment tool that measures the subject's ability to control a myoelectric hand. The ability to control gripping, holding, releasing, and coordinating 30 items is scored on a 4-point capability scale. The prosthetic hand is used in an active assist or passive support role. Rasch analysis is used to convert capability ratings to a single measure of each subject's functional ability. Both Ms Turner and Dr. Miller are trained to complete this assessment.
Measured: Baseline and 8 weeks for Condition A; Baseline and 8 weeks for Condition B
Orthotics and Prosthetics User Survey - Upper Extremity Function Status
A 19- item, self-reported measure of an individual's ability to perform self-care and upper limb-based daily living tasks (e.g. button shirt, tie shoelaces) using a 5-point scale [35]. Rasch analysis of the questionnaire ratings is used to calculate an overall measure of each subject's functional ability.
Measured: Baseline and 8 weeks for Condition A; Baseline and 8 weeks for Condition B
Patient Specific Functional Scale
A questionnaire that asks patients to list up to five tasks they have difficulty with and rate the difficulty on an 11-point numerical scale [36]. Difficulty ratings can be averaged for each participant.
Measured: Baseline and 8 weeks for Condition A; Baseline and 8 weeks for Condition B
Clothespin Relocation Test
A test of prosthetic function that requires the user to move three clothespins from a vertical bar to a horizontal bar (thereby requiring use of the elbow, terminal device, and wrist rotator). This test has been in use by CBM as a measure of prosthesis function for over a decade.
Measured: Baseline and 8 weeks for Condition A; Baseline and 8 weeks for Condition B
Virtual Testing: Target Achievement Control Test
For the TAC Test, participants must move the virtual hand into a target posture and hold it there for a preset period of time. The TAC Test can require movement of from one to all available degrees of freedom (e.g. hand grasp plus wrist motion). Results are measured in terms of classification accuracy, completion rate, completion time, and path efficiency. This test will be used to ensure that subjects have satisfactory PR control over all DOFs prior to starting their home trial.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start18 Jan 2018
- Primary completion19 Feb 2024
- Study completion19 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Limb Amputation at the HandStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Study Design includes using the subjects to complete both aims in a balanced randomized cross-over study. Using blocked randomization, which will be achieve using a simple randomization script written in Matlab. The two study conditions that will be analyzed are: Condition A-a single DOF terminal device with a 1-DOF (rotation) wrist Condition B-a single DOF terminal device with a 2-DOF (rotation + flexion/extension) wrist Condition A is the control condition in this project as it represents the state-of-the-art in clinical care. Condition B is the experimental arm.
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Levi Hargrove, Shirley Ryan AbilityLab
- Investigators
- Levi Hargrove, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04069793
- Sponsor's protocol ID
- STU00206531
- Other IDs
- 5R01HD094861-02
- Status last verified
- Jul 2025
- First submitted
- 9 Aug 2019
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Functional Importance of a Powered Multifunction Wrist
- ClinicalTrials.gov ID
- NCT04069793
- Acronym / sponsor ID
- STU00206531
- Conditions
- Upper Limb Amputation at the Hand, Upper Limb Amputation at the Wrist, Amputation, Amputation; Traumatic, Limb
- Keywords
- Transradial Amputee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 18 Jan 2018 (actual)
- Primary completion
- 19 Feb 2024 (actual)
- Study completion
- 19 Feb 2024 (actual)
- First posted
- 28 Aug 2019 (actual)
- 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 focus of this study is to conduct a clinical study in individuals with transradial amputations to compare function using a 1-DOF or 2-DOF wrist. All prostheses will be attached to a single DOF Otto Bock hand and controlled using a pattern recognition system equivalent to the Coapt system. This study will enable the investigator to quantify the relative functional value of powered wrist flexion during both in-laboratory testing and home use. In addition, the investigators will address the effectiveness of different hand-wrist combinations to enhance patient-centered clinical decision making.
Detailed description
The primary objective of this project is to evaluate the functional importance of a multi function wrist compared to a single degree of freedom wrist. This will be accomplished through in laboratory testing and an 8-week home trial. The first aim will involve in-laboratory functional performance testing with a 1-DOF or a 2-DOF wrist and a one degree of freedom hand.
Changes in performance will be assessed with multiple outcome measures that include both quantitative and qualitative testing of prosthesis control and functional performance. The second aim will determine how a 2-DOF wrist impacts control and home use of a one degree of freedom hand. Subjects will compete an 8 week home based trial. Participants will be instructed to complete a written home log of activities and electronic logging usage data will also be collected for each experimental condition. The investigators hypothesize that adding a wrist flexion/extension module to a wrist rotation module and a single-DOF terminal device will provide significant improvements in function for transradial amputees.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Study Design includes using the subjects to complete both aims in a balanced randomized cross-over study. Using blocked randomization, which will be achieve using a simple randomization script written in Matlab. The two study conditions that will be analyzed are: Condition A-a single DOF terminal device with a 1-DOF (rotation) wrist Condition B-a single DOF terminal device with a 2-DOF (rotation + flexion/extension) wrist Condition A is the control condition in this project as it represents the state-of-the-art in clinical care. Condition B is the experimental arm.
| Arm | Type | Receives |
|---|---|---|
| Home Trial Condition A | Active comparator | Device: Commercially available deviceSubject will use a pattern recognition controlled prosthesis that includes a powered wrist rotation, passive wrist flexion/extension, and a single DOF powered hand. |
| Home Trial Condition B | Experimental | Device: Non FDA registered deviceSubject will use at pattern recognition controlled prosthesis that includes a powered wrist rotation, powered flexion/extension and a single DOF powered hand. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ages 18-95
- A unilateral upper limb amputation or absence below the elbow
- English speaking
Key exclusion criteria (3 listed)
- Significant new injury that would prevent use of a prosthesis: The ability to consistently wear a prosthesis and perform activities of daily living and specific performance tasks is necessary to evaluate the relative benefits of the interventions.
- Cognitive impairment sufficient to adversely affect understanding of or compliance with study requirements, ability to communicate experiences, or ability to give informed consent: The ability to understand and comply with requirements of the study is essential in order for the study to generate useable, reliable data. The ability to obtain relevant user feedback through questionnaires and informal discussion adds significant value to this study.
- Significant other comorbidity: Any other medical issues or injuries that would preclude completion of the study, use of the prostheses, or that would otherwise prevent acquisition of useable data by researchers
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 |
|---|---|---|
| Commercially available deviceA commercially available and registered with the FDA prosthesis equipped with a powered single-degree of freedom wrist and powered hand. | Device | Home Trial Condition A |
| Non FDA registered deviceAn experimental, non FDA registered prosthesis equipped with a multi function wrist and a powered hand. | Device | Home Trial Condition B |
Primary outcome
Academy of Prosthetics and Orthotics ULPOM committee toolkit of outcome measures to record change of prosthetic performance
Time frame: Baseline and 8 weeks for Condition A; Baseline and 8 weeks for Condition B
Measuring the function of upper limb prostheses is challenging and requires multiple test formats. A toolkit of functional outcome tests recommend by the Academy of Prosthetics and Orthotics ULPOM committee will be used to measure functional effectiveness of prosthetic treatment will be used as the primary outcome measure. The outcome measures to evaluate prosthesis use includes both quantitative and qualitative testing of prosthesis control and functional performance.
8 secondary outcomes
SHAP: Southampton Hand Assessment Procedure; a clinically validated hand function test to assess the effectiveness of upper limb prostheses.
Time frame: Baseline and 8 weeks for Condition A; Baseline and 8 weeks for Condition B
Modified Box and Blocks Test of Manual Dexterity
Time frame: Baseline and 8 weeks for Condition A; Baseline and 8 weeks for Condition B
Jebsen-Taylor Hand Function Test
Time frame: Baseline and 8 weeks for Condition A; Baseline and 8 weeks for Condition B
Assessment of Capacity for Myoelectric Control (ACMC)
Time frame: Baseline and 8 weeks for Condition A; Baseline and 8 weeks for Condition B
Orthotics and Prosthetics User Survey - Upper Extremity Function Status
Time frame: Baseline and 8 weeks for Condition A; Baseline and 8 weeks for Condition B
Patient Specific Functional Scale
Time frame: Baseline and 8 weeks for Condition A; Baseline and 8 weeks for Condition B
Clothespin Relocation Test
Time frame: Baseline and 8 weeks for Condition A; Baseline and 8 weeks for Condition B
Virtual Testing: Target Achievement Control Test
Time frame: 2 days
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 4 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Levi Hargrove principal investigator
Shirley Ryan AbilityLab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Commercially available device and Non FDA registered device in people with Upper Limb Amputation at the Hand and Upper Limb Amputation at the Wrist, run by Shirley Ryan AbilityLab 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 3 inclusion and 3 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 4 Jul 2025. 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?
Academy of Prosthetics and Orthotics ULPOM committee toolkit of outcome measures to record change of prosthetic performance (time frame: Baseline and 8 weeks for Condition A; Baseline and 8 weeks for Condition B). 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 4 Jul 2025.