This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Early Rehabilitation After Transfemoral Amputation in Moderately Active Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06045468
Recruitment Status : Recruiting
First Posted : September 21, 2023
Last Update Posted : September 29, 2023
Sponsor:
Collaborators:
Otto Bock Healthcare Products GmbH
University Medical Center Mainz
Information provided by (Responsible Party):
Johannes Schroeter, Median

Tracking Information
First Submitted Date  ICMJE September 13, 2023
First Posted Date  ICMJE September 21, 2023
Last Update Posted Date September 29, 2023
Actual Study Start Date  ICMJE January 5, 2023
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2023)
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) ]
Patient reported outcome measurement with 12 questions assessing mobility; reported as t-score, max. t-score: 65.7
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2023)
  • 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
  • EuroQol questionnaire (EQ-5D-5L) [ Time Frame: 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, score 0-1 with 0 meaning lowest quality of life and 1 highest quality of life
  • Falls [ Time Frame: 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 [ Time Frame: 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 numeric rating scale (0-10) with 0 meaning no fear of falling and 10 meaning maximum fear of falling
  • Locomotor capability index (LCI 5) [ Time Frame: 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 [ Time Frame: 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 [ 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 ]
    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 [ 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 ]
    Patient walks back and forth 12 m for 6 minutes, distance in meter is recorded
  • 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 ]
    Functional outcome measurement, amputated-specific, assesses different activities of daily life, max. score 43 points
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2023)
  • 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
  • EQ-5D-5L [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ 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 ]
    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 [ 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 ]
    Patient walks back and forth 12 m for 6 minutes, distance in meter is recorded
  • 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 ]
    Functional outcome measurement, amputated-specific, assesses different activities of daily life, max. score 43 points
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Early Rehabilitation After Transfemoral Amputation in Moderately Active Patients
Official Title  ICMJE Observational Study on Early Rehabilitation After Transfemoral Amputation in Moderately Active Patients, Provided With Kenevo (Ottobock)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Non-randomized clinical trial
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Transfemoral Amputation
Intervention  ICMJE
  • Other: Amputation-specialized rehabilitation
    Study center; amputation-specialized unit within rehabilitation facility; fully practicing national guidelines
  • Other: Non-amputation-specialized rehabilitation
    Control clinics; treating some amputated patients each year but do not practice national guidelines or partially practicing national guidelines
Study Arms  ICMJE
  • Experimental: Study group
    Patients in inpatient rehabilitation in study center.
    Intervention: Other: Amputation-specialized rehabilitation
  • Experimental: Control group
    Patients in inpatient rehabilitation facility of collaborating clinics.
    Intervention: Other: Non-amputation-specialized rehabilitation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 13, 2023)
125
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2024
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Johannes Schröter, Dr. med. 0049611757811 johannes.schroeter@median-kliniken.de
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06045468
Other Study ID Numbers  ICMJE Kenevo2023
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Johannes Schroeter, Median
Original Responsible Party Johannes Schroeter, Median, Dr. med.
Current Study Sponsor  ICMJE Median
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Otto Bock Healthcare Products GmbH
  • University Medical Center Mainz
Investigators  ICMJE Not Provided
PRS Account Median
Verification Date September 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP