Sit-to-stand Trainer in Patients After Lower Limb Amputation (STSTrainer)

Effect of Sit-to-stand Trainer in Patients With Unilateral Lower Limb Amputation on the Ability of Independent Standing up

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.

Study Overview

• Status: Withdrawn
• Conditions: Lower Limb Amputation
• Intervention / Treatment: Device: Sit-to-stand trainer

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • University Rehabilitation Institute, Republic of Slovenia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	Device: 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.
NO_INTERVENTION: Standard Training; Standard training of standing-up with the help of a physiotherapist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Standing-up pattern	Detailed qualitative kinesiological analysis Will be performed to determine the standing-up pattern.	On day 10 after the last training session

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Berg Balance Scale	The scale measures functional balance. The participants are asked to perform 14 tasks frequently used in daily life activities. The highest possible score is 56 points. A higher score indicates better balance.	On day 10 after the last training session
6-Minute Walk Test	The test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. Longer distance indicates better functional capacity.	On day 10 after the last training session

Collaborators and Investigators

• Sponsor: University Rehabilitation Institute, Republic of Slovenia

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 6, 2019
• Primary Completion (ACTUAL): August 30, 2020
• Study Completion (ACTUAL): August 30, 2020

Study Registration Dates

• First Submitted: September 5, 2019
• First Submitted That Met QC Criteria: September 9, 2019
• First Posted (ACTUAL): September 11, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 16, 2021
• Last Update Submitted That Met QC Criteria: February 12, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: unilateral lower-lim amputation; sit-to-stand trainer device; 30-Second Chair Stand Test; kinesiological analysis
• Other Study ID Numbers: URIS201903

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No