N/A
N=11
Personalizing MPK Prescription
Transfemoral Amputation
Bottom Line
View on ClinicalTrials.gov: NCT06399471 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Ten Meter Walking Test — 0.9963; 1.1051; 1.1111 Meters per second — p=0.126
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Microprocessor prosthetic knee (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Georgia Institute of Technology
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ten Meter Walking Test |
0.9963; 1.1051; 1.1111 | 0.126 |
| PRIMARY Two Minute Walking Test |
1.073; 1.2106; 1.1698 | 0.003 sig |
| PRIMARY Prosthetic Evaluation Questionnaire (PEQ) |
69.4; 83.2; 78.4 | 0.006 sig |
| SECONDARY Stance Time Asymmetry Index |
-10.15; -10.95; -7.03 | 0.687 |
| SECONDARY Narrowing Beam Walking Test |
11.3; 12.6; 13.5 | 0.082 |
| SECONDARY Reported Falls |
0.06429; 0.04286; 0.01429 | 0.943 |
| SECONDARY Physiological Cost Index |
0.29; 0.25; 0.27 | 0.535 |
| SECONDARY Stair Ascent Speed |
50.463; 56.336; 48.336 | 0.229 |
| SECONDARY Stair Descent Speed |
92.65; 93.997; 88.3 | 0.528 |
| SECONDARY Ramp Ascent Speed |
0.8929; 0.969; 0.971 | 0.144 |
| SECONDARY Ramp Descent Speed |
0.7643; 0.869; 0.8584 | 0.051 |
| SECONDARY Steps Per Day |
2620.1; 2762.6; 2462.6 | 0.367 |
Summary
In current clinical prosthetic practice, there is no evidence based method for selecting a microprocessor knee (MPK) joint for a patient with an above the knee amputation. Of individuals with amputation in veteran and service member populations, approximately 35% present with an above the knee amputation. It is well understood in clinical practice that MPKs provide numerous benefits to patients with amputations above the knee including improved gait, safety, comfort, confidence, reduced falls, balance, patient satisfaction and reduced energy expenditure, greater ease in negotiating varying terrains, improvements in multi-tasking and cost effectiveness. Studies that have investigated commercially available MPKs tend to lump all of them together within a single group rather than teasing out individual differences between each knee. Therefore, clinicians are left to rely on their own intuition and past experiences with an MPK when selecting for a patient with an above the knee amputation rather than making their decision based on evidence collected from the specific patient. This may mean that some individuals with an above the knee amputation may not be receiving the best component for them which may delay or inhibit their rehabilitation potential following their amputation.
Eligibility Criteria
Inclusion Criteria
- A unilateral transfemoral amputation of the lower limb at least six months post fitting of definitive lower extremity prosthesis
- Habitual use of a lower extremity prosthesis in daily living activities (based on assessment of a physiatrist and/or prosthetist and patient self-report)
- Aged between 18 to 75 years
- K3 or K4 level ambulators who can perform all locomotor tasks of interest (based on assessment of a physiatrist and/or prosthetist)
Exclusion Criteria
- Individuals with any significant neuromuscular or musculoskeletal disorder or other comorbidity that would interfere with participation (based on assessment of the physiatrist and/or prosthetist and patient self-report)
- Individuals who have open wounds on their residual limb
- Individuals with known visual impairments that would prevent them from safely operating a prosthesis during over ground walking or ascending stairs (based on assessment of the physiatrist and/or prosthetist and patient self-report)
- Individuals with known hearing impairments or who use hearing aids that would prevent them from responding to an auditory instruction (based on assessment of the physiatrist and/or prosthetist and patient self-report)
- Individuals who are currently pregnant (based on patient self-report) due to slight risk of falling during experiments
Data sourced from ClinicalTrials.gov (NCT06399471). 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.