- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04069793
Functional Importance of a Powered Multifunction Wrist Protocol
Determining the Functional Importance of a Powered Multifunction Wrist
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Suzanne Finucane
- Phone Number: 3122380937
- Email: sfinucane@sralab.org
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Shirley Ryan AbilityLab
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Ages 18-95
- A unilateral upper limb amputation or absence below the elbow
- English speaking
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Home Trial Condition A
Subject will use a pattern recognition controlled prosthesis that includes a powered wrist rotation, passive wrist flexion/extension, and a single DOF powered hand.
|
A commercially available and registered with the FDA prosthesis equipped with a powered single-degree of freedom wrist and powered hand.
|
Experimental: Home Trial Condition B
Subject will use at pattern recognition controlled prosthesis that includes a powered wrist rotation, powered flexion/extension and a single DOF powered hand.
|
An experimental, non FDA registered prosthesis equipped with a multi function wrist and a powered hand.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline and 8 weeks for Condition A; Baseline and 8 weeks for Condition B
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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.
|
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
|
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.
|
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
|
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
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
Baseline and 8 weeks for Condition A; Baseline and 8 weeks for Condition B
|
Virtual Testing: Target Achievement Control Test
Time Frame: 2 days
|
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.
|
2 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Levi Hargrove, Shirley Ryan AbilityLab
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU00206531
- 5R01HD094861-02 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Amputation
-
Liberating Technologies, Inc.Eunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedAmputation | Prosthesis User | Amputation; Traumatic, Hand | Amputation, CongenitalUnited States
-
Boninger, Michael, MDNational Institute of Neurological Disorders and Stroke (NINDS); Ripple Therapeutics...RecruitingAmputation | Amputation; Traumatic, HandUnited States
-
Fondazione Don Carlo Gnocchi OnlusCompletedAmputation | Amputation; Traumatic, Leg, LowerItaly
-
Fondazione Don Carlo Gnocchi OnlusCompletedAmputation | Amputation; Traumatic, Leg, LowerItaly
-
Medipol UniversityRecruitingEvaluation of Functionality of Amputees According to the Medicare Functional K Classification SystemAmputation | Amputation; Traumatic, Leg, LowerTurkey
-
University of MichiganActive, not recruitingAmputation | Amputation; Traumatic, Leg, LowerUnited States
-
Shirley Ryan AbilityLabUnited States Department of DefenseCompletedAmputation | Amputation; Traumatic, Arm, UpperUnited States
-
Hacettepe UniversityCompleted
-
Liberating Technologies, Inc.Vivonics, Inc.CompletedLower Limb Amputation Below Knee (Injury) | Amputation | Prosthesis User | Amputation; Traumatic, Leg, Lower | Limb; Absence, Congenital, Lower | Amputation StumpUnited States
-
Coapt, LLCCongressionally Directed Medical Research ProgramsCompletedProsthesis User | Congenital Amputation of Upper Limb | Amputation; Traumatic, LimbUnited States
Clinical Trials on Commercially available device
-
University of TennesseeKinetic Concepts, Inc.Completed
-
Curaseal Inc.UnknownAnal Fistulas | Rectal FistulasSpain
-
MedtronicNeuroRecruitingPain, Chronic | Pain, IntractableUnited States
-
University of the PacificCompletedCardiovascular DiseasesUnited States
-
Colorado State UniversityInstitute of Cannabis Research (ICR)--Colorado State University, PuebloRecruitingAlcohol Use Disorder | Cannabis UseUnited States
-
Massachusetts General HospitalHarvard School of Public Health (HSPH)Completed
-
Universitair Ziekenhuis BrusselCompletedInfertility, FemaleBelgium
-
Direct Flow Medical, Inc.UnknownAortic Valve StenosisUnited States
-
Milton S. Hershey Medical CenterCompletedBehavioral Responses to Bright Light Therapy in EldersUnited States
-
University of UtahRecruiting