N/A
N=10
Functional Outcomes in Dysvascular Transfemoral Amputees
Transfemoral Amputation · Unilateral Traumatic Amputation of Leg at or Above Knee
Bottom Line
View on ClinicalTrials.gov: NCT01537211 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Change in Community Physical Activity as Measured by GPS — 1749; 1625; 1257 Steps per day
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- C leg compared to subject's mechanical leg (Otto Bock) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Shirley Ryan AbilityLab
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Community Physical Activity as Measured by GPS |
1749; 1625; 1257 | — |
| SECONDARY Change in 6 Minute Walk Test From Baseline |
434.0; 472.2; 476.4 | — |
| SECONDARY Change in 10 Meter Walk Test Gait Speed From Baseline |
0.483; 0.645; 0.764 | — |
| SECONDARY Change in Amputee Mobility Predictor Score From Baseline |
30; 34; 36 | — |
| SECONDARY Change in Berg Balance Score From Baseline |
35; 39; 44 | — |
| SECONDARY Change in Timed Up and Go Test Time From Baseline |
29.95; 29.91; 25.32 | — |
| SECONDARY Change in Four Square Step Test Time From Baseline |
17.96; 19.74; 16.79 | — |
| SECONDARY Change in Modified Falls Efficacy Scale From Baseline |
7.58; 8.61; 9.33 | — |
| SECONDARY Change in Community Participation Indicators From Baseline |
49.26; 50.16; 55.83; 61.68; 65.28; 74.69 | — |
| SECONDARY Change in Prosthesis Evaluation Questionnaire (PEQ) From Baseline |
58.64; 58.28; 81.92; 69.80; 68.78; 85.91 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Males or females with dysvascular transfemoral amputations
- 6 months or more post prosthetic fitting
- Homebound or limited community ambulators post amputation
- Ability to walk > 50m in a 2 min walk test
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01537211). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.