Functional Outcomes in Dysvascular Transfemoral Amputees

NCT01537211 | Completed Results

• 1 other identifier: STU00042823
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

In older adults, poor circulation in the lower extremities leads to serious health complications including limb loss. In addition, individuals with dysvascular disease also suffer from other co-morbidities like diabetes, coronary and cerebrovascular disease. An individual with a transfemoral (TF) amputation is usually fitted with a prosthetic limb to assist with function, including a prosthetic knee and a prosthetic foot. Currently, dysvascular amputees are given a prosthetic knee based on the basic expectation that they will be functionally stable. This consideration does not address higher levels of function like walking at multiple speeds and over uneven ground. Also, dysvascular amputees are not able to counteract their co-morbidities with a more active lifestyle. Walking is less energy efficient; their traditional prostheses may cause early onset of fatigue and induce a fear of falling. Newer microprocessor knees enable patients with transfemoral amputations to walk on different surfaces and at multiple cadences through better control in swing and stance phases of gait. The impact of the functional differences in the prostheses is not clear and requires additional investigation to clarify the choice of the most appropriate functional prosthesis. The purpose of this study is to compare the functional outcomes with the traditional mechanical knee versus the microprocessor knee (C-leg) in transfemoral amputees.

Conditions

Transfemoral Amputation; Unilateral Traumatic Amputation of Leg at or Above Knee

Keywords

Dysvascular; amputation; above knee; ambulation

Outcome Measures

Primary Outcomes (1)

• Change in Community Physical Activity as Measured by GPS

  The difference in social mobility (as seen by GPS) between the 2 devices will be measured.

  baseline, 1 month with mechanical knee, 1 month with microprocessor knee

Secondary Outcomes (9)

• Change in 6 Minute Walk Test From Baseline

  After 3 month acclimation period to device

• Change in 10 Meter Walk Test Gait Speed From Baseline

  After 3 month acclimation period to device

• Change in Amputee Mobility Predictor Score From Baseline

  After 3 month acclimation period to device

• Change in Berg Balance Score From Baseline

  After 3 month acclimation period to device

• Change in Timed Up and Go Test Time From Baseline

  After 3 month acclimation period to device

Study Arms (2)

Microprocessor knee then Mechanical knee

EXPERIMENTAL

Device: C leg compared to subject's mechanical leg (Otto Bock)

Mechanical Knee then Microprocessor knee

EXPERIMENTAL

Device: C leg compared to subject's mechanical leg (Otto Bock)

Interventions

C leg compared to subject's mechanical leg (Otto Bock) DEVICE

comparison of different prosthetic knees

Also known as: Otto Bock

Mechanical Knee then Microprocessor knee

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females with dysvascular transfemoral amputations
• months or more post prosthetic fitting
• Homebound or limited community ambulators post amputation
• Ability to walk \> 50m in a 2 min walk test

You may not qualify if:

• Traumatic, cancer or genetic amputation
• Co-morbidity that completely prevents physical activity
• Significant skin lesions/ulcers on stump that prevent fitting of prosthesis
• Cognitive deficits or visual impairments that would impair their ability to give informed consent or to follow simple instructions during experiment

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• Otto Bock Healthcare: collaborator

Study Sites (1)

Rehabilitation Institute of Chicago, 345 E Superior St

Chicago, Illinois, 60611, United States

Location

Related Publications (2)

• Theeven P, Hemmen B, Rings F, Meys G, Brink P, Smeets R, Seelen H. Functional added value of microprocessor-controlled knee joints in daily life performance of Medicare Functional Classification Level-2 amputees. J Rehabil Med. 2011 Oct;43(10):906-15. doi: 10.2340/16501977-0861.

  PMID: 21947182 BACKGROUND

• Jayaraman C, Mummidisetty CK, Albert MV, Lipschutz R, Hoppe-Ludwig S, Mathur G, Jayaraman A. Using a microprocessor knee (C-Leg) with appropriate foot transitioned individuals with dysvascular transfemoral amputations to higher performance levels: a longitudinal randomized clinical trial. J Neuroeng Rehabil. 2021 May 25;18(1):88. doi: 10.1186/s12984-021-00879-3.

  PMID: 34034753 DERIVED

Results Point of Contact

• Title: Arun Jayaraman, PT, PhD; Director of Max Nader Lab for Rehabilitation Technologies and Outcomes
• Organization: Rehabilitation Institute of Chicago

ajayaraman@ricres.org

3122386875

Study Officials

• Arun Jayaraman, PT PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Rehab Technolgoies and Outcomes Lab

Study Record Dates

• First Submitted: February 7, 2012
• First Posted: February 23, 2012
• Study Start: August 1, 2011
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: September 6, 2019
• Results First Posted: September 6, 2019

Record last verified: 2019-08

Locations

US (1)