Early Rehabilitation After Transfemoral Amputation in Moderately Active Patients

NCT06045468 | Unknown

• 1 other identifier: Kenevo2023
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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).

Conditions

Transfemoral Amputation

Keywords

Kenevo; MPK; specialized inpatient rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Reintegration to normal living index (RNLI)

  As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation)

• EuroQol questionnaire (EQ-5D-5L)

  As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation)

• Falls

  As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation)

• Fear of falling

  As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation)

• Locomotor capability index (LCI 5)

  As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation)

Study Arms (2)

Study group

EXPERIMENTAL

Patients in inpatient rehabilitation in study center.

Other: Amputation-specialized rehabilitation

Control group

EXPERIMENTAL

Patients in inpatient rehabilitation facility of collaborating clinics.

Other: Non-amputation-specialized rehabilitation

Interventions

Amputation-specialized rehabilitation OTHER

Study center; amputation-specialized unit within rehabilitation facility; fully practicing national guidelines

Study group

Non-amputation-specialized rehabilitation OTHER

Control clinics; treating some amputated patients each year but do not practice national guidelines or partially practicing national guidelines

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• non-German speaking
• not able to give informed consent
• body weight over 125kg

Sponsors & Collaborators

• Median: lead
• Otto Bock Healthcare Products GmbH: collaborator
• University Medical Center Mainz: collaborator

Study Sites (1)

MEDIAN Clinics

Wiesbaden, Germany

RECRUITING

Central Study Contacts

Johannes Schröter, Dr. med.

CONTACT

0049611757811; johannes.schroeter@median-kliniken.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Orthopaedic clinic

Model Details: Non-randomized clinical trial

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: September 21, 2023
• Study Start: January 5, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 29, 2023

Record last verified: 2023-09

Locations

DE (1)