Clinical trial NCT06045468: Early Rehabilitation After Transfemoral Amputation in Moderately Active Patients
Official title: Observational Study on Early Rehabilitation After Transfemoral Amputation in Moderately Active Patients, Provided With Kenevo (Ottobock)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Transfemoral Amputation
Keywords: Kenevo
MPK
specialized inpatient rehabilitation
Lead sponsor: Median
Sponsor class: OTHER
Collaborators: name: Otto Bock Healthcare Products GmbH
name: University Medical Center Mainz
First posted: 2023-09-21
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-randomized clinical trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Treatment and rehabilitation after transfemoral amputation represents a challenging medical field, involving intersectoral parties. Although treatment guidelines exists, their implementation is difficult. This study is conducted to evaluate the need to practice these guidelines in order to gain best benefits for the patients. Focus is set of early inpatient rehabilitation and the role of a microprocessor-controlled prothesis (Kenevo, Ottobock).

Detailed description: Right after major surgeries, e.g. amputations, inpatient rehabilitation follows in Germany. Costs are covered by different insurances, like public or private health care insurances or German pension insurance. Usually, inpatient rehabilitation lasts for 3 weeks. But after some surgeries, like amputation, patients need more time to recover and fitting of a prosthesis takes additional time. Therefore guidelines state, that rehabilitation should take up to 6-8 weeks after major amputation. To provide evidence to these guidelines, we conducted this study.

Patients' choice on rehabilitation clinic decides on their assignment to the study group or control group. Inpatient rehabilitation is monitored with outcomes measurements. 3 measurements are carried out in the study group within rehabilitational stay of around 6 weeks (admission - middle - discharge) and 2 measurements are carried out in the control group within rehabilitational stay of around 3 weeks (admission - discharge). After discharge from rehabilitation, assessment of patient reported outcome measurements is continued every 6 weeks for both groups. Follow-up phase ends with 24 weeks after admission to rehabilitation.

For subanalysis, different prosthetic devices (non-microprocessor-controlled vs. microprocessor-controlled prosthesis) are compared.

Eligibility criteria: Inclusion Criteria:

* inpatient rehabilitation stay after transfemoral amputation or knee disarticulation
* anticipated K-level 1 or 2
* body weight no more than 125kg (authorized body weight for prosthetic device)
* German speaking
* able to give informed consent

Exclusion Criteria:

* non-German speaking
* not able to give informed consent
* body weight over 125kg

Primary outcomes:
measure: Prosthetic Limb User's Survey of Mobility (PLUS-M)
timeFrame: As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation)
Secondary outcomes:
measure: Reintegration to normal living index (RNLI)
timeFrame: As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation)
measure: EuroQol questionnaire (EQ-5D-5L)
timeFrame: As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation)
measure: Falls
timeFrame: As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation)
measure: Fear of falling
timeFrame: As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation)
measure: Locomotor capability index (LCI 5)
timeFrame: As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation)
measure: Barthel Index
timeFrame: As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation)
measure: Timed Up and Go Test
timeFrame: At admission to rehabilitation facility (if patients are already equipped with a prosthesis), after 3 weeks and after 6 weeks (discharge from rehabilitation) of inpatient rehabilitation stay
measure: 6 minute walking test
timeFrame: At admission to rehabilitation facility (if patients are already equipped with a prosthesis), after 3 weeks and after 6 weeks (discharge from rehabilitation) of inpatient rehabilitation stay
measure: AMP-PRO
timeFrame: At admission to rehabilitation facility (if patients are already equipped with a prosthesis), after 3 weeks and after 6 weeks (discharge from rehabilitation) of inpatient rehabilitation stay
Other outcomes:
Locations:
city: Wiesbaden
country: Germany
facility: MEDIAN Clinics
Study officials:
References: