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

Not Applicable

Withdrawn

• Conditions: Lower Limb Amputation
• Interventions: Device: Sit-to-stand trainer

• Registration Number: NCT04086069
• Lead Sponsor: University Rehabilitation Institute, Republic of Slovenia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-06
• Study First Submitted: 2019-09-05
• Study First Submitted QC: 2019-09-09
• Study First Posted: 2019-09-11
• Primary Completion: 2020-08-30
• Study Completion: 2020-08-30
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-12
• Last Update Posted: 2021-02-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Training+Sit-to-stand trainer	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

Primary Outcome Measures

Name	Time	Method
Change in 30-Second Chair Stand Test	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 Outcome Measures

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

Trial Locations

Locations (1)

University Rehabilitation Institute, Republic of Slovenia; 🇸🇮 Ljubljana, Slovenia