Early Rehabilitation After Transfemoral Amputation in Moderately Active Patients
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Study group Patients in inpatient rehabilitation in study center. |
Other: Amputation-specialized rehabilitation
Study center; amputation-specialized unit within rehabilitation facility; fully practicing national guidelines
|
| Experimental: Control group Patients in inpatient rehabilitation facility of collaborating clinics. |
Other: Non-amputation-specialized rehabilitation
Control clinics; treating some amputated patients each year but do not practice national guidelines or partially practicing national guidelines
|
Outcome Measures
Primary Outcome Measures
- Prosthetic Limb User's Survey of Mobility (PLUS-M) [As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation)]
Patient reported outcome measurement with 12 questions assessing mobility; reported as t-score, max. t-score: 65.7
Secondary Outcome Measures
- Reintegration to normal living index (RNLI) [As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation)]
Patient reported outcome measurement with 11 questions asking to patients' reintegration into daily life, reported as percentage
- EQ-5D-5L [As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation)]
Patient reported outcome measurement assessing quality of life, reported as health utility, score, max. score 1
- Falls [As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation)]
Number of falls with prothesis
- Fear of falling [As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation)]
indoor and outdoor fear of falling on a NRS (0-10)
- Locomotor capability index (LCI 5) [As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation)]
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
- Barthel Index [As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation)]
Patient reported outcome measurement assessing patients' self care, 10 questions with maximum score of 100 points
- Timed Up and Go Test [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]
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
- 6 minute walking test [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]
Patient walks back and forth 12 m for 6 minutes, distance in meter is recorded
- AMP-PRO [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]
Functional outcome measurement, amputated-specific, assesses different activities of daily life, max. score 43 points
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | MEDIAN Clinics | Wiesbaden | Germany |
Sponsors and Collaborators
- Median
- Otto Bock Healthcare Products GmbH
- University Medical Center Mainz
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Kenevo2023