Sit-to-stand Trainer in Patients After Lower Limb Amputation

NCT ID: NCT04086069

Last Updated: 2021-02-16

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-06

Study Completion Date

2020-08-30

Brief Summary

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The study will include rehabilitation inpatients after unilateral lower limb amputation who are candidates for walking with a prosthesis. Those in the experimental group will receive training using a sit-to-stand trainer device in addition to standard training of standing-up with the help of a physiotherapist. Those in the control group will only receive the standard training. The effects of the rehabilitation programme will be assessed using the 30-Second Chair Stand Test before the start of the training and after 10 days of training. For the first five patients from each group who will be able to stand up with the use of hands, detailed kinesiological analysis of standing-up pattern will be performed.

Detailed Description

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Conditions

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Lower Limb Amputation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard Training+Sit-to-stand trainer

Training using a sit-to-stand trainer device in addition to standard training of standing-up with the help of a physiotherapist

Group Type EXPERIMENTAL

Sit-to-stand trainer

Intervention Type DEVICE

The sit-to-stand trainer device is an exoskeleton that enables standing-up movement resembling the movement of a healthy person. It consists of three sub-systems: a foldable chair, a lever for body orientation and a triggering mechanism. It includes a support for feet with adjustable height. The device offers partial support to the patient while standing up. The patient will exercise with the device for 10 sessions (one per day), standing up for up to 30 times per session.

Standard Training

Standard training of standing-up with the help of a physiotherapist

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Sit-to-stand trainer

The sit-to-stand trainer device is an exoskeleton that enables standing-up movement resembling the movement of a healthy person. It consists of three sub-systems: a foldable chair, a lever for body orientation and a triggering mechanism. It includes a support for feet with adjustable height. The device offers partial support to the patient while standing up. The patient will exercise with the device for 10 sessions (one per day), standing up for up to 30 times per session.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* unilateral lower-limb amputation
* candidate for walking with a prosthesis
* Montreal Cognitive Assessment (MoCA) test score 26 or more

Exclusion Criteria

* associated neurological or orthopaedic disease
* amputation caused by cancer or injury
* BMI below 18.5 or above 30
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Rehabilitation Institute, Republic of Slovenia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Helena Burger, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Rehabilitation Institute, Republic of Slovenia

Locations

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University Rehabilitation Institute, Republic of Slovenia

Ljubljana, , Slovenia

Site Status

Countries

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Slovenia

References

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B Aledi L, Flumignan CD, Trevisani VF, Miranda F Jr. Interventions for motor rehabilitation in people with transtibial amputation due to peripheral arterial disease or diabetes. Cochrane Database Syst Rev. 2023 Jun 5;6(6):CD013711. doi: 10.1002/14651858.CD013711.pub2.

Reference Type DERIVED
PMID: 37276273 (View on PubMed)

Other Identifiers

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URIS201903

Identifier Type: -

Identifier Source: org_study_id

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