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

Overview

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.

Full Title of Study: “Effect of Sit-to-stand Trainer in Patients With Unilateral Lower Limb Amputation on the Ability of Independent Standing up”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2020

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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
  • No Intervention: Standard Training
    • Standard training of standing-up with the help of a physiotherapist

Clinical Trial Outcome Measures

Primary Measures

  • Change in 30-Second Chair Stand Test
    • Time Frame: Change from day 0 to day 10
    • 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.

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Rehabilitation Institute, Republic of Slovenia
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Helena Burger, MD, PhD, Principal Investigator, University Rehabilitation Institute, Republic of Slovenia
  • Overall Contact(s)
    • Helena Burger, MD, PhD, +386 1 4758441, helena.burger@ir-rs.si

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