Early Rehabilitation After Transfemoral Amputation in Moderately Active Patients

Transfemoral Amputation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06045468
• Other study ID #: Kenevo2023
• Status: Recruiting
• Phase: N/A
• Start date: January 5, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: Median
• Contact: Johannes Schröter, Dr. med.
• Phone: 0049611757811
• Email: johannes.schroeter[@]median-kliniken.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Transfemoral Amputation

Intervention

Other:
• Amputation-specialized rehabilitation
Study center; amputation-specialized unit within rehabilitation facility; fully practicing national guidelines
• Non-amputation-specialized rehabilitation
Control clinics; treating some amputated patients each year but do not practice national guidelines or partially practicing national guidelines

Locations

Country	Name	City	State
Germany	MEDIAN Clinics	Wiesbaden

Sponsors (3)

Lead Sponsor	Collaborator
Median	Otto Bock Healthcare Products GmbH, University Medical Center Mainz

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	Falls	Number of falls with prothesis	As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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