Interface Kinematics of Transhumeral Prosthetic Sockets Using XROMM

NCT01546675 | Completed Results

• 1 other identifier: A9227-P
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this pilot study was to conduct a head-to-head comparison of two designs for transhumeral level upper limb prosthetic sockets: a traditional socket design and a socket design hypothesized to provide greater skeletal stabilization. The investigators comparisons included assessments of patient comfort and satisfaction with fit, as well as dynamic kinematic assessment using X-Ray Reconstruction of Moving Morphology (XROMM) a novel high-speed, high-resolution, bi-plane video radiography system.

Conditions

Traumatic Amputation of Arm

Keywords

Amputation; Prosthesis Design; Biomechanics

Outcome Measures

Primary Outcomes (3)

• Degrees of Shoulder Abduction Within the Prosthetic Socket

  Shoulder abduction was performed to the subject's maximum elevation. Skeletal and socket kinematics were calculated using the markerless auto-registration algorithm and X-Ray Reconstruction of Moving Morphology (XROMM)

  After 4 weeks of home use (2 weeks for each socket style)

• Degrees of Shoulder Internal Rotation Within the Prosthetic Socket

  Isometric internal rotation was performed with the prosthetic elbow flexed to 90 degrees and shoulder in neutral position. Skeletal and socket kinematics were calculated using the markerless auto-registration algorithm and X-Ray Reconstruction of Moving Morphology (XROMM)

  After 4 weeks of home use (2 weeks for each socket style)

• Degrees of Shoulder Displacement Within the Prosthetic Socket

  A shoulder shrug task was achieved by pulling up on a strap attached to the load cell, which was mounted on the vertical face of the concrete pedestal. Skeletal and socket kinematics were calculated using the markerless auto-registration algorithm and X-Ray Reconstruction of Moving Morphology (XROMM)

  After 4 weeks of home use (2 weeks for each socket style)

Secondary Outcomes (3)

• Trinity Amputations and Prosthetics Experience Satisfaction Scale (TAPES)

  After 4 weeks of home use (2 weeks for each socket style)

• Prosthetic Evaluation Questionnaire (PEQ) - Utility Subscale

  after 2 weeks of home use of each socket type

• Prosthetic Evaluation Questionnaire (PEQ) - Residual Limb Health Subscale

  After 4 weeks of home use (2 weeks for each socket style)

Study Arms (2)

Traditional 1, Skeletal Stabilization 2

ACTIVE COMPARATOR

Subjects using the Traditional Socket and socket hypothesized to increase skeletal stabilization in a case cross-over design. The intervention is the socket designed to increase skeletal stabilization.

Other: Skeletal Stabilization

Skeletal Stabilization 1, Traditional 2

EXPERIMENTAL

Subjects using the socket hypothesized to increase skeletal stabilization and Traditional Socket and in a case cross-over design. The intervention is the socket designed to increase skeletal stabilization.

Other: Skeletal Stabilization

Interventions

Skeletal Stabilization OTHER

Upper Limb Prosthetic Socket hypothesized to increase skeletal stabilization

Also known as: Skeletal Stabilization Socket

Skeletal Stabilization 1, Traditional 2; Traditional 1, Skeletal Stabilization 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female transhumeral amputees, 18 years or older of any ethnicity, who are current prosthetic users.

You may not qualify if:

• Subjects with frozen shoulder of the residual side, and/or severely limited active range of motion of the shoulder joint of the residual limb
• Inability to tolerate wearing of a prosthetic socket
• Mental impairment that renders a subject unable to comply with the study
• Skin conditions such as burns or poor skin coverage as well as those with severe contractures that prevent prior prosthetic wear
• Any electrically controlled medical device including pacemaker, implanted defibrillator or drug pumps
• Neuropathy, uncontrolled diabetes, receiving dialysis
• Any other significant comorbidity which would interfere with the study
• Severe circulatory problems including peripheral vascular disease and pitting edema will be excluded
• Cognitive deficits or mental health problems that would limit ability to participate fully in the study protocol
• Women who are pregnant or who plan to become pregnant in the near future

Sponsors & Collaborators

• US Department of Veterans Affairs: lead
• Lifespan: collaborator
• Brown University: collaborator

Study Sites (2)

Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

New York, New York, 10010, United States

Location

Providence VA Medical Center, Providence, RI

Providence, Rhode Island, 02908, United States

Location

Related Publications (1)

• Resnik L, Patel T, Cooney SG, Crisco JJ, Fantini C. Comparison of transhumeral socket designs utilizing patient assessment and in vivo skeletal and socket motion tracking: a case study. Disabil Rehabil Assist Technol. 2016;11(5):423-32. doi: 10.3109/17483107.2014.981876. Epub 2014 Nov 26.

  PMID: 25425411 DERIVED

Limitations and Caveats

These results cannot be generalized outside of this small sample and may have been different if the intervention socket had been optimized. Additional research is needed to expand our understanding of the impact of prosthetic socket designs.

Results Point of Contact

• Title: Linda Resnik, PT, PhD
• Organization: Department of Veterans Affairs

linda.resnik@va.gov

401-273-7100

Study Officials

• Linda J Resnik, PhD MS

  Providence VA Medical Center, Providence, RI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2012
• First Posted: March 7, 2012
• Study Start: January 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: September 1, 2013
• Last Updated: November 24, 2014
• Results First Posted: November 24, 2014

Record last verified: 2014-11

Locations

US (2)