A study on the feasibility and safety of stand-up trainig using a device that assists sit-to-stand and stand-to-sit postural transfer in patients with trunk and lower limb impairments

Phase 2

Recruiting

• Conditions: Patients with trunk and lower limb impariments who have difficulty standing

• Registration Number: JPRN-jRCTs032230302
• Lead Sponsor: Hada Yasushi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-08-22
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1) Patients with difficulty standing up who have trunk and lower limb impairments.
2) Patients who are able to give written consent. (However, if the patient has difficulty in writing, a substitute will be provided.)
3) Patients who are 16 years of age or older. (If the patient is under 18 years of age, a signature by a person with parental authority or a guardian is required in addition to the signature of the patient himself/herself.)
4) Patients who are capable of sitting and standing exercises with conventional physical therapy.
5) Patients who can wear Qolo.
(Although a height of 150 cm to 190 cm is assumed, the condition of use is not height but patients whose body size, such as thigh length, lower leg length, and waist width, fits the Qolo.)
6) Patients who weigh between 40 kg and 100 kg.

Exclusion Criteria

1) Patients who have difficulty performing voluntary exercise according to instructions due to impaired consciousness or cognitive decline.
2) Patients with instability of vital signs. Specifically, cardiovascular patients such as myocardial infarction or dissecting aneurysm within 2 weeks of onset. Patients with uncontrolled arrhythmias, etc.
3) Patients with uncontrolled infections.
4) Patients who are deemed to have difficulty in standing training due to osteoarticular diseases (spinal or joint diseases) with severe deformity or pain.
5) Patients deemed inappropriate by the principal investigator or subinvestigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility of voluntary sit-to-stand training : the ratio of the patients who can complete more than three times of the intervention program which includes at least one time of standing up and sitting down using Qolo