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

Lower Limb Amputation Clinical Trial

— STSTrainer  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04086069
• Other study ID #: URIS201903
• Status: Withdrawn
• Phase: N/A
• Start date: February 6, 2019
• Est. completion date: August 30, 2020

Study information

• Verified date: February 2021
• Source: University Rehabilitation Institute, Republic of Slovenia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 30, 2020
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lower Limb Amputation

Intervention

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.

Locations

Country	Name	City	State
Slovenia	University Rehabilitation Institute, Republic of Slovenia	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University Rehabilitation Institute, Republic of Slovenia

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	Standing-up pattern	Detailed qualitative kinesiological analysis Will be performed to determine the standing-up pattern.	On day 10 after the last training session