Personalizing MPK Prescription

Transfemoral Amputation Clinical Trial

Official title:

Personalizing MPK Prescription for Individuals With Transfemoral Amputation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06399471
• Other study ID #: H21008
• Status: Completed
• Phase: N/A
• Start date: October 25, 2021
• Est. completion date: October 2, 2023

Study information

• Verified date: May 2024
• Source: Georgia Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 2, 2023
• Est. primary completion date: October 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Transfemoral Amputation

Intervention

Device:
• Microprocessor prosthetic knee
Microprocessor prosthetic knees for use in a transfemoral prosthesis

Locations

Country	Name	City	State
United States	Georgia Institute of Technology	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Georgia Institute of Technology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-selected walking speed	walking speed overground, on stairs and ramps	2 years
Secondary	Physiological cost index	a clinical measure of energy expenditure	2 years
Secondary	Narrowing beam walking test	a measure of balance via walking down a narrowing beam	2 years
Secondary	Prosthetic Evaluation Questionnaire	a patient reported survey on perceptions of a prosthesis	2 years