Personalizing MPK Prescription

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-25

Study Completion Date

2023-10-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of a Microprocessor-controlled Prosthetic Knee Joint on K2 Level Ambulators

NCT07103798

Transfemoral Amputation Limb Loss Limb Absence

NOT_YET_RECRUITING NA

Active Knee Prosthesis Study

NCT06700668

Transfemoral Amputation

ACTIVE_NOT_RECRUITING NA

Comparative Effectiveness Between Microprocessor Knees and Non-Microprocessor Knees

NCT02240186

Lower Limb Amputation Above Knee (Injury)

COMPLETED NA

Effects of Microprocessor-controlled Prosthetic Knees on Fall-related Health Outcomes in Limited Community Ambulators

NCT06937242

Amputation Prosthesis User Amputation; Traumatic, Leg: Thigh, Between Hip and Knee +3 more

NOT_YET_RECRUITING NA

Clinical Outcomes With Passive MPKs vs. Powered Prosthetic Knees

NCT05267639

Amputation Amputation; Traumatic, Leg, Lower Limb; Absence, Congenital, Lower +3 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Transfemoral Amputation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Study Microprocessor Prosthetic Knee

Randomization to C-Leg 4.0, Rheo Knee and Power Knee

Group Type EXPERIMENTAL

Microprocessor prosthetic knee

Intervention Type DEVICE

Microprocessor prosthetic knees for use in a transfemoral prosthesis

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Microprocessor prosthetic knee

Microprocessor prosthetic knees for use in a transfemoral prosthesis

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

C-Leg Power Knee Rheo

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No