Clinical trial NCT06399471: Personalizing MPK Prescription
Official title: Personalizing MPK Prescription for Individuals With Transfemoral Amputation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transfemoral Amputation
Lead sponsor: Georgia Institute of Technology
Sponsor class: OTHER
First posted: 2024-05-03
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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

Primary outcomes:
measure: Ten Meter Walking Test
timeFrame: 1 month
measure: Two Minute Walking Test
timeFrame: 1 month
measure: Prosthetic Evaluation Questionnaire (PEQ)
timeFrame: 1 month
Secondary outcomes:
measure: Stance Time Asymmetry Index
timeFrame: 1 month
measure: Narrowing Beam Walking Test
timeFrame: 1 month
measure: Reported Falls
timeFrame: 1 month
measure: Physiological Cost Index
timeFrame: 1 month
measure: Stair Ascent Speed
timeFrame: 1 month
measure: Stair Descent Speed
timeFrame: 1 month
measure: Ramp Ascent Speed
timeFrame: 1 month
measure: Ramp Descent Speed
timeFrame: 1 month
measure: Steps Per Day
timeFrame: 1 month
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Georgia Institute of Technology
state: Georgia
Study officials:
References: