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Early Rehabilitation After Transfemoral Amputation in Moderately Active Patients

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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

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
Transfemoral Amputation Other: Amputation-specialized rehabilitation Other: Non-amputation-specialized rehabilitation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Non-randomized clinical trial
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Observational Study on Early Rehabilitation After Transfemoral Amputation in Moderately Active Patients, Provided With Kenevo (Ottobock)
Actual Study Start Date : January 5, 2023
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06045468


Contacts
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Contact: Johannes Schröter, Dr. med. 0049611757811 johannes.schroeter@median-kliniken.de

Locations
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Germany
MEDIAN Clinics Recruiting
Wiesbaden, Germany
Contact: Johannes Schroeter, Dr. med.    0049 611 575811    johannes.schroeter@median-kliniken.de   
Sponsors and Collaborators
Median
Otto Bock Healthcare Products GmbH
University Medical Center Mainz
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Responsible Party: Johannes Schroeter, Director of Orthopaedic clinic, Median
ClinicalTrials.gov Identifier: NCT06045468    
Other Study ID Numbers: Kenevo2023
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: September 29, 2023
Last Verified: September 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johannes Schroeter, Median:
Kenevo
MPK
specialized inpatient rehabilitation