Early Rehabilitation After Transfemoral Amputation in Moderately Active Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-05

Study Completion Date

2024-12-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Transfemoral Amputation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Non-randomized clinical trial

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Study group

Patients in inpatient rehabilitation in study center.

Group Type EXPERIMENTAL

Amputation-specialized rehabilitation

Intervention Type OTHER

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

Control group

Patients in inpatient rehabilitation facility of collaborating clinics.

Group Type EXPERIMENTAL

Non-amputation-specialized rehabilitation

Intervention Type OTHER

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

Interventions

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Amputation-specialized rehabilitation

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

Intervention Type OTHER

Non-amputation-specialized rehabilitation

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

Intervention Type OTHER

Eligibility Criteria

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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