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

Study Overview
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Brief Summary
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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.

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

Conditions
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Lower Limb Amputation

Intervention / Treatment
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* Device: Sit-to-stand trainer


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard Training+Sit-to-stand trainer<br>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<br>* 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.<br>|
| No Intervention: Standard Training<br>Standard training of standing-up with the help of a physiotherapist | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unilateral lower-lim amputation, sit-to-stand trainer device, 30-Second Chair Stand Test, kinesiological analysis