Clinical trial NCT04069793: Functional Importance of a Powered Multifunction Wrist Protocol
Official title: Determining the Functional Importance of a Powered Multifunction Wrist
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Upper Limb Amputation at the Hand
Upper Limb Amputation at the Wrist
Amputation
Amputation; Traumatic, Limb
Keywords: Transradial Amputee
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2019-08-28
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: BASIC_SCIENCE

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Academy of Prosthetics and Orthotics ULPOM committee toolkit of outcome measures to record change of prosthetic performance
timeFrame: Baseline and 8 weeks for Condition A; Baseline and 8 weeks for Condition B
Secondary outcomes:
measure: SHAP: Southampton Hand Assessment Procedure; a clinically validated hand function test to assess the effectiveness of upper limb prostheses.
timeFrame: Baseline and 8 weeks for Condition A; Baseline and 8 weeks for Condition B
measure: Modified Box and Blocks Test of Manual Dexterity
timeFrame: Baseline and 8 weeks for Condition A; Baseline and 8 weeks for Condition B
measure: Jebsen-Taylor Hand Function Test
timeFrame: Baseline and 8 weeks for Condition A; Baseline and 8 weeks for Condition B
measure: Assessment of Capacity for Myoelectric Control (ACMC)
timeFrame: Baseline and 8 weeks for Condition A; Baseline and 8 weeks for Condition B
measure: Orthotics and Prosthetics User Survey - Upper Extremity Function Status
timeFrame: Baseline and 8 weeks for Condition A; Baseline and 8 weeks for Condition B
measure: Patient Specific Functional Scale
timeFrame: Baseline and 8 weeks for Condition A; Baseline and 8 weeks for Condition B
measure: Clothespin Relocation Test
timeFrame: Baseline and 8 weeks for Condition A; Baseline and 8 weeks for Condition B
measure: Virtual Testing: Target Achievement Control Test
timeFrame: 2 days
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
Study officials:
affiliation: Shirley Ryan AbilityLab
name: Levi Hargrove
role: PRINCIPAL_INVESTIGATOR
References: