- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06045468
Early Rehabilitation After Transfemoral Amputation in Moderately Active Patients
Observational Study on Early Rehabilitation After Transfemoral Amputation in Moderately Active Patients, Provided With Kenevo (Ottobock)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Johannes Schröter, Dr. med.
- Phone Number: 0049611757811
- Email: johannes.schroeter@median-kliniken.de
Study Locations
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Wiesbaden, Germany
- Recruiting
- MEDIAN Clinics
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Contact:
- Johannes Schroeter, Dr. med.
- Phone Number: 0049 611 575811
- Email: johannes.schroeter@median-kliniken.de
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Study group
Patients in inpatient rehabilitation in study center.
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Study center; amputation-specialized unit within rehabilitation facility; fully practicing national guidelines
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Experimental: Control group
Patients in inpatient rehabilitation facility of collaborating clinics.
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Control clinics; treating some amputated patients each year but do not practice national guidelines or partially practicing national guidelines
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prosthetic Limb User's Survey of Mobility (PLUS-M)
Time Frame: As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation)
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Patient reported outcome measurement with 12 questions assessing mobility; reported as t-score, max.
t-score: 65.7
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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)
Time Frame: 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
|
As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation)
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Falls
Time Frame: As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation)
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Number of falls with prothesis
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As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation)
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Locomotor capability index (LCI 5)
Time Frame: As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation)
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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
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As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation)
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Barthel Index
Time Frame: As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation)
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Patient reported outcome measurement assessing patients' self care, 10 questions with maximum score of 100 points
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As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation)
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Timed Up and Go Test
Time Frame: 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
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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
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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
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6 minute walking test
Time Frame: 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
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Patient walks back and forth 12 m for 6 minutes, distance in meter is recorded
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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
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AMP-PRO
Time Frame: 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
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Functional outcome measurement, amputated-specific, assesses different activities of daily life, max.
score 43 points
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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
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EuroQol questionnaire (EQ-5D-5L)
Time Frame: As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation)
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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
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As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation)
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Fear of falling
Time Frame: As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation)
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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
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As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Kenevo2023
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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