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

NCT04086069 | Withdrawn

• 1 other identifier: URIS201903
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lower Limb Amputation

Keywords

unilateral lower-lim amputation; sit-to-stand trainer device; 30-Second Chair Stand Test; kinesiological analysis

Outcome Measures

Primary Outcomes (1)

• Change in 30-Second Chair Stand Test

  The test measures the number of times the participant is able to stand and return to a seated position in a chair in 30 seconds.

  Change from day 0 to day 10

Secondary Outcomes (1)

• Standing-up pattern

  On day 10 after the last training session

Other Outcomes (2)

• Berg Balance Scale

  On day 10 after the last training session

• 6-Minute Walk Test

  On day 10 after the last training session

Study Arms (2)

Standard Training+Sit-to-stand trainer

EXPERIMENTAL

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

Device: Sit-to-stand trainer

Standard Training

NO INTERVENTION

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

Interventions

Sit-to-stand trainer 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+Sit-to-stand trainer

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• associated neurological or orthopaedic disease
• amputation caused by cancer or injury
• BMI below 18.5 or above 30

Sponsors & Collaborators

• University Rehabilitation Institute, Republic of Slovenia: lead

Study Sites (1)

University Rehabilitation Institute, Republic of Slovenia

Ljubljana, 1000, Slovenia

Location

Related Publications (1)

• 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.

  PMID: 37276273 DERIVED

Study Officials

• Helena Burger, MD, PhD

  University Rehabilitation Institute, Republic of Slovenia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: September 11, 2019
• Study Start: February 6, 2019
• Primary Completion: August 30, 2020
• Study Completion: August 30, 2020
• Last Updated: February 16, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)