NCT00417352

Brief Summary

Current improvements of the design of the upper limb prosthesis include advanced technology in control systems and electronic circuitry that mimic human motion and improve function of the prosthesis. Often times these improvements require large amounts of power, circuitry and excess mass distally along the prosthesis that may require greater effort from the user. Poor function of an upper limb prosthesis may cause awkward compensatory motion. Aberrant movements, such as these compensatory movements are known to cause greater stress to remaining joints. Amputees are forced to decide if the extra function provided by the advanced electronics is worth carrying the extra mass which may cause fatigue, socket issues and greater stress on the remaining joints. An example is the wrist rotator component of an upper limb prosthesis which may allow greater function and reduce compensatory motion, but adds mass distally, potentially causing greater torques on remaining joints. GOALS OF THE STUDY: There are two main goals of this study:

  1. 1.to determine the impact of an upper limb prosthesis without a wrist rotator on the compensatory motion and torques in the remaining joints during common tasks
  2. 2.to determine the impact of the location (distally or proximally) of a wrist rotator on a upper limb prosthesis on the compensatory motion during common tasks
  3. 3.There will be a statistically significant difference in range of motion of the upper limb joints between healthy subjects, braced subjects and upper limb amputees during four common tasks.
  4. 4.There will be a statistically significant difference in joint upper limb joint torques between healthy subjects, braced subjects and upper limb amputees during three common tasks.
  5. 5.There will be a statistically significant difference in upper limb angles and joint torques between mass added distally and mass added proximally during common tasks.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

December 28, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 1, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

August 6, 2010

Status Verified

December 1, 2006

Enrollment Period

1 year

First QC Date

December 28, 2006

Last Update Submit

August 5, 2010

Conditions

Keywords

no interventionbracing restricted forearm and wrist movementbracing with added mass near elbowbracing with added mass near wrist

Outcome Measures

Primary Outcomes (7)

  • shoulder abduction

  • shoulder flexion

  • elbow flexion

  • shoulder joint force

  • should joint torque

  • elbow joint force

  • elbow joint torque

Interventions

BraceDEVICE

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ages 18-60 years old
  • Control group: normal, healthy volunteers
  • Amputee group: unilateral, transradial myoelectric prosthesis users

You may not qualify if:

  • elderly \> 60
  • children \< 18
  • pregnant women
  • persons with shoulder impairments, injuries, or problems
  • bilateral upper limb amputees

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Florida

Tampa, Florida, 33620, United States

Location

MeSH Terms

Interventions

Braces

Intervention Hierarchy (Ancestors)

Orthotic DevicesOrthopedic EquipmentSurgical EquipmentEquipment and Supplies

Study Officials

  • Stephanie L Carey, PhD

    University of South Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 28, 2006

First Posted

January 1, 2007

Study Start

December 1, 2006

Primary Completion

December 1, 2007

Study Completion

May 1, 2008

Last Updated

August 6, 2010

Record last verified: 2006-12

Locations