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Active, Not Recruiting

NCT Number: NCT04784429

Assessing Outcomes With Microprocessor Knee Utilization in a K2 Population

Two-phased randomized controlled trial comparing the impact of microprocessor controlled knee prostheses (MPK) with the impact of non-microprocessor controlled knee prostheses (NPMK) in patients with a transfemoral/knee disarticulation level amputation categorized as K2 ambulators.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hanger Clinic - 321 Westgate Pkwy, Dothan, Alabama, United States

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About this study

Randomized controlled trial investigating the benefits of microprocessor controlled knee prostheses (MPK) in patients with a transfemoral or knee disarticulation level amputation categorized by Medicare Functional Classification Level (MFCL) as a Limited Community Ambulator (K-Level 2). There are two aims for the study. Aim 1 is to understand the effect of MPK technology for the K2 ambulator on reducing fear and anxiety of falling, improving health-related quality of life, and participation in society and activities. Aim 2 is to understand the long-term effect of MPK technology the aspects from Aim 1 as well as reducing morbidity. The trial will be conducted in two phases. Phase 1 will cover the initial 12-month period to address Aim 1, and phase 2 will monitor from 12 months to 5 years to address Aim 2.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Unilateral transfemoral or knee disarticulation amputation
  • Received prosthesis between 4 - 24 months prior
  • Currently uses prosthesis
  • K2 ambulator status
  • Able to speak English or Spanish language
  • Age ≥ 65 years at Baseline Assessment (one month after enrollment)
  • Minimum Socket Comfort Score (SCS) of 6/10

Exclusion criteria

  • Upper limb involvement
  • Individuals ≥ 275 lbs
  • Unable to provide informed consent
  • History of acute or chronic residual limb breakdown
  • History of 2 or more socket adjustments or replacements in the past 6 months
  • Amputation of the contralateral limb
  • Active malignancy
  • Rapidly declining health status resulting in reduced activity in the past 6 months, as determined by patient's clinician and confirmed by Clinical & Scientific Affairs personnel
  • Patient unable or unwilling to follow study procedures
  • Pregnant women, institutionalized persons, and children

Treatment and study plan

Kenevo or C-Leg 4

Device

Kenevo fitted to subjects walking slower than 0.8 m/s as measured by the 2-minute Walk Test. C-Leg 4 fitted to subjects walking faster than 0.8 m/s.

Non microprocessor controlled knee (NMPK)

Device

NMPK consistent with current standards of care

Primary outcomes

  1. Fear of Falling Avoidance Behavior Questionnaire (FFABQ)

    Time frame: 12 months

    This is a 14 item survey assessment originally developed with community-dwelling older adults which measures the degree to which respondents avoid activities due to their fear of falling. Responses are on a 5-point scale with 0 = completely disagree and 4 = completely agree. The total possible score is 56 points. A higher score indicates a greater activity limitation and participation restriction as a result of the fear of falling.

  2. Fear of Falling Avoidance Behavior Questionnaire (FFABQ)

    Time frame: 5 years

    This is a 14 item survey assessment originally developed with community-dwelling older adults which measures the degree to which respondents avoid activities due to their fear of falling. Responses are on a 5-point scale with 0 = completely disagree and 4 = completely agree. The total possible score is 56 points. A higher score indicates a greater activity limitation and participation restriction as a result of the fear of falling.

Secondary outcomes

  1. Patient-Reported Outcomes Measurement Information System (PROMIS) - 29

    Time frame: 12 months

    The survey assessment comprises from 7 health domains (physical function, anxiety, depression, fatigue, sleep disturbance, satisfaction with social roles, and pain interference). The combined constructs serve to provide a measure of patient's quality of life. Raw scores are converted to T-scores which standardizes the scores with a mean of 50 and standard deviation of 10. Being above or below the standard deviation could be desirable or undesirable based on the domain being measured. Higher scores means more of the concept being measured (e.g. more fatigue).

  2. Patient-Reported Outcomes Measurement Information System (PROMIS) - Ability to Participate in Social Roles and Activities (APSRA)

    Time frame: 12 months

    Within the PROMIS system, this specific set of question is aimed at assessing the person's ability to perform usual social roles and activities, a construct noted to be of great significance to well-being within the World Health Organization International Classification of Function model. Four of the PROMIS-APSRA questions are included on the PROMIS-29 within the domain of 'satisfaction with social roles'. The addition of four more questions helps with the responsiveness within this specific domain. Thus the additional four questions of the PROMIS-APSRA will be administered to assess the domain of participation and activity.

  3. 12-month fall count from bi-weekly fall journal

    Time frame: 12 months

    On a bi-weekly cadence, individuals will be asked to complete the Lower Limb Amputation Fall Survey. This survey was developed for the purpose of documenting number of falls and near-falls over a given period, as well as insight into the causality.

  4. Average daily step counts

    Time frame: 12 months

    Difference in average daily step activity count from 1 week after initial assessment compared to average daily step activity count for 1 week prior to 12-month assessment. Modern activity monitors provide the ability to translate movement from triaxial inertial measurement units into corresponding step activity with great precision.

  5. Fear of Falling Avoidance Behavior Questionnaire (FFABQ)

    Time frame: 3 years

    This is a 14 item survey assessment originally developed with community-dwelling older adults which measures the degree to which respondents avoid activities due to their fear of falling. Responses are on a 5-point scale with 0 = completely disagree and 4 = completely agree. The total possible score is 56 points. A higher score indicates a greater activity limitation and participation restriction as a result of the fear of falling.

  6. Patient-Reported Outcomes Measurement Information System (PROMIS) - 29

    Time frame: 5 years

    The survey assessment comprises from 7 health domains (physical function, anxiety, depression, fatigue, sleep disturbance, satisfaction with social roles, and pain interference). The combined constructs serve to provide a measure of patient's quality of life. Raw scores are converted to T-scores which standardizes the scores with a mean of 50 and standard deviation of 10. Being above or below the standard deviation could be desirable or undesirable based on the domain being measured. Higher scores means more of the concept being measured (e.g. more fatigue).

  7. Patient-Reported Outcomes Measurement Information System (PROMIS) - Ability to Participate in Social Roles and Activities (APSRA)

    Time frame: 5 years

    Within the PROMIS system, this specific set of question is aimed at assessing the person's ability to perform usual social roles and activities, a construct noted to be of great significance to well-being within the World Health Organization International Classification of Function model. Four of the PROMIS-APSRA questions are included on the PROMIS-29 within the domain of 'satisfaction with social roles'. The addition of four more questions helps with the responsiveness within this specific domain. Thus the additional four questions of the PROMIS-APSRA will be administered to assess the domain of participation and activity.

  8. 10-meter Walk Test (10mWT)

    Time frame: 5 years

    The 10mWT is a standardized test of self-selected walking speed in which patients are timed over the middle 6 meters (19.7 feet) of a 10-meter (32.8 feet) flat walkway. The self-selected walking speed is calculated in meters per second and has been discussed as a potential vital sign given its strong relationship with survival. It will serve as a marker of morbidity.

  9. Timed Up and Go (TUG)

    Time frame: 5 years

    The Timed Up-and-Go test is a standard basic mobility test that includes a sit-to-stand, gait initiation, walking, turning, and stand-to-sit. The test measures, in seconds, the time to stand up from an arm chair, walk a distance of 3 meters (approximately 10 feet), turn, walk back to the chair and sit down. It is a measure of function, has been used to assess the risk of falling, and will serve as a marker of morbidity.

  10. Patient-Reported Outcomes Measurement Information System (PROMIS) - 29

    Time frame: 3 years

    Difference in average daily step activity count from 1 week after initial assessment compared to average daily step activity count for 1 week prior to 5-year assessment. Modern activity monitors provide the ability to translate movement from triaxial inertial measurement units into corresponding step activity with great precision.

  11. Patient-Reported Outcomes Measurement Information System (PROMIS) - Ability to Participate in Social Roles and Activities (APSRA)

    Time frame: 3 years

    Within the PROMIS system, this specific set of question is aimed at assessing the person's ability to perform usual social roles and activities, a construct noted to be of great significance to well-being within the World Health Organization International Classification of Function model. Four of the PROMIS-APSRA questions are included on the PROMIS-29 within the domain of 'satisfaction with social roles'. The addition of four more questions helps with the responsiveness within this specific domain. Thus the additional four questions of the PROMIS-APSRA will be administered to assess the domain of participation and activity.

  12. 10-meter Walk Test (10mWT)

    Time frame: 3 years

    The 10mWT is a standardized test of self-selected walking speed in which patients are timed over the middle 6 meters (19.7 feet) of a 10-meter (32.8 feet) flat walkway. The self-selected walking speed is calculated in meters per second and has been discussed as a potential vital sign given its strong relationship with survival. It will serve as a marker of morbidity.

  13. Timed Up and Go (TUG)

    Time frame: 3 years

    The Timed Up-and-Go test is a standard basic mobility test that includes a sit-to-stand, gait initiation, walking, turning, and stand-to-sit. The test measures, in seconds, the time to stand up from an arm chair, walk a distance of 3 meters (approximately 10 feet), turn, walk back to the chair and sit down. It is a measure of function, has been used to assess the risk of falling, and will serve as a marker of morbidity.

Sponsors and collaborators

Lead sponsor

Otto Bock Healthcare Products GmbH

Industry

Collaborators

  • Hanger Clinic: Prosthetics & Orthotics

Registry information

Acronym: ASCENT K2

Important dates

Study start
2021
Primary completion
2023
Study completion
2026
First posted
Mar 5, 2021
Registry last updated
Feb 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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