Early Rehabilitation After Transfemoral Amputation in Moderately Active Patients

Study Overview
=================
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.

Official Title
-----------------
Observational Study on Early Rehabilitation After Transfemoral Amputation in Moderately Active Patients, Provided With Kenevo (Ottobock)

Conditions
-----------------
Transfemoral Amputation

Intervention / Treatment
-----------------
* Other: Amputation-specialized rehabilitation
* Other: Non-amputation-specialized rehabilitation


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Non-randomized clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>Patients in inpatient rehabilitation in study center. | Other: Amputation-specialized rehabilitation<br>* Study center; amputation-specialized unit within rehabilitation facility; fully practicing national guidelines<br>|
| Experimental: Control group<br>Patients in inpatient rehabilitation facility of collaborating clinics. | Other: Non-amputation-specialized rehabilitation<br>* Control clinics; treating some amputated patients each year but do not practice national guidelines or partially practicing national guidelines<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prosthetic Limb User's Survey of Mobility (PLUS-M) | Patient reported outcome measurement with 12 questions assessing mobility; reported as t-score, max. t-score: 65.7 | As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reintegration to normal living index (RNLI) | Patient reported outcome measurement with 11 questions asking to patients' reintegration into daily life, reported as percentage | As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation) | 
| EuroQol questionnaire (EQ-5D-5L) | Patient reported outcome measurement assessing quality of life, reported as health utility, score, score 0-1 with 0 meaning lowest quality of life and 1 highest quality of life | As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation) | 
| Falls | Number of falls with prothesis | As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation) | 
| Fear of falling | indoor and outdoor fear of falling on a numeric rating scale (0-10) with 0 meaning no fear of falling and 10 meaning maximum fear of falling | As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation) | 
| Locomotor capability index (LCI 5) | Patient reported outcome measurement assessing patients' locomotor capability, 14 questions, results are categorized in 2 dimension: basic or advanced activities, maximum score is 28 points for each dimension | As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation) | 
| Barthel Index | Patient reported outcome measurement assessing patients' self care, 10 questions with maximum score of 100 points | As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation) | 
| Timed Up and Go Test | Functional outcome measurement, assessing patients' capability to walk, time needed to get up from a chair, walk 3 m, turn and walk 3 m back until sitting down again | 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 | 
| 6 minute walking test | Patient walks back and forth 12 m for 6 minutes, distance in meter is recorded | 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 | 
| AMP-PRO | Functional outcome measurement, amputated-specific, assesses different activities of daily life, max. score 43 points | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kenevo, MPK, specialized inpatient rehabilitation