Effect of a Microprocessor-controlled Prosthetic Knee Joint on K2 Level Ambulators
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-85
SponsorVA Office of Research and Development
About this trial
Microprocessor-controlled knees (MPKs) automatically adjust resistance or damping in the joint to improve swing- and/or stance-phase control as appropriate for the prosthesis user during gait. The purpose of this proposed investigation is to determine if there are substantial physical and psychological benefits to fitting lower functioning Veteran ambulators having transfemoral amputations with an MPK compared with a nonmicroprocessor-controlled knee (NMPK). Using a repeated-measures, cross-sectional experimental design, approximately 20 Veterans with unilateral, transfemoral amputations will be evaluated on two separate occasions at the Jesse Brown VA Medical Center or the Edward Hines, Jr. VA Hospital, first with their conventional NMPK and then again after a 2-month accommodation period with the College Park Icon MPK.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Unilateral, transfemoral amputation (any etiology)
Residual limb length classified as standard (i.e., medium) to long
Prosthesis user for at least 1 year prior to enrolling in the study
K2-level classification while using their nonmicroprocessor-controlled knee (NMPK)
Disqualifiers
Bilateral leg amputations
Individuals with a knee disarticulation
Trial design
Design model
Crossover
Treatments tested in this trial
College Park ICON
Other interventionSubjects will be fitted and trained on the College Park ICON MPK. An accommodation period of 2 months will be provided prior to evaluation with the knee joint.
Conventional NMPK
Other interventionSubjects will be tested walking with their conventional, mechanical prosthetic knee prior to being fitted with the MPK.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Microprocessor-controlled knees (MPK)Experimental treatment 1 intervention
Group B: Nonmicroprocessor-controlled knee (NMPK)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Walking speed
Walking speed will be measured as participants walk on level ground at slow, normal and fast speeds.
Time frame
To be measured before and immediately following the 2-month accommodation period of wearing the microprocessor-controlled knee the microprocessor-controlled knee (MPK)2
Falls during walking
The number of falls that occur while the subject is walking will be recorded in a daily diary.
Time frame
To be determined before and during the 2-month accommodation period of wearing the the microprocessor-controlled knee (MPK)3
PLUS-M
The Prosthetic Limb User Survey of Mobility (PLUS-M) will be used to determine the mobility of subjects before and after fitting with the MPK. Scores range from 12-60 points, and a higher score indicates greater mobility.
Time frame
To be measured before and immediately following the 2-month accommodation period of wearing the the microprocessor-controlled knee (MPK)4
Prosthetic Knee Preference
Subjects will be asked which prosthetic knee they prefer at the completion of the study. For those that indicate preference for the the microprocessor-controlled knee (MPK), they will be permitted to keep it in their prosthesis. For those that prefer the nonmicroprocessor-controlled knee (NMPK), their prosthesis will be restored to the configuration prior to beginning the study.
Time frame
To be asked immediately following the 2-month accommodation period of wearing the the microprocessor-controlled knee (MPK)Secondary outcomes
1
ABC Scale
The Activities-specific Balance Confidence (ABC) Scale measures the subject's confidence in not losing their balance or becoming unsteady while performing different activities. Scores range from 0-100%, where zero represents no confidence and 100 represents complete confidence in performing an activity without losing balance or becoming unsteady.
Time frame
To be administered before and immediately following the 2-month accommodation period of wearing the the microprocessor-controlled knee (MPK)2
OPUS
The Orthotics and Prosthetics User's Survey (OPUS) is a self-report questionnaire that can be used for quality assessment, to maintain awareness of improvement in activities, to evaluate changes in patient's functional status and quality of life, and to assess satisfaction with devices and services. Scores range from 0-80 points, with a higher score indicating greater functional mobility.
Time frame
To be administered before and immediately following the 2-month accommodation period of wearing the the microprocessor-controlled knee (MPK)Sponsors and contacts
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Source ClinicalTrials.gov
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