NIPH Clinical Trials Search

JRCT ID: jRCTs032230302

Registered date:22/08/2023

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

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedPatients with trunk and lower limb impariments who have difficulty standing
Date of first enrollment23/10/2023
Target sample size40
Countries of recruitment
Study typeInterventional
Intervention(s)standing and stting training using Qolo


Primary OutcomeFeasibility 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
Secondary OutcomeDuration of the intervention program (each session, total) Assist level settings during the intervention program (each session) Number of times of standing up and sitting down during the intervention program (each session, total) Standing time in the intervention program (each time, total) Fatigue level in the intervention program: modified Borg scale (each time) Caregiver fatigue in the intervention program: modified Borg scale (each time) Disease occurrence Failure of test equipment (each time; occurrence of rattling, breakage, etc.) (Each session refers to each session of the intervention program.) *Hearafter, the items apply to only feasible cases: Motor paralysis: Fugl-Mayer Assessment (FMA) of lower limb (affected side only) Lower limb muscle strength: Isometric knee extension strength (both right and left sides) Trunk function: Trunk Impairment Scale (TIS) Berg Balance Scale (BBS) Trunk Assessment Scale for Spinal Cord Injury(TASS) Gait Independence: Functional Ambulation Category (FAC) Gait function: 6-meter gait test Ability to stand up: 30-second chair stand test (CS-30) Walking ability and dynamic balance: Timed Up & Go Test (TUG) ADL: Functional Independence Measure (FIM) Japanese modified Rankin Scale (mRS) Cognitive function: Mini-Mental State Examination (MMSE) Stroke severity: National Institutes of Health Stroke Scale (NIHSS) Movement analysis: movement analysis of standing up and walking, muscle activity measurement, and movement measurement using accelerometers Brain function tests: functional MRI, functional near-infrared spectroscopy, transcranial magnetic stimulation, and muscle activity measurement to examine and evaluate brain activity and brain function.

Key inclusion & exclusion criteria

Age minimum>= 16age old
Age maximumNot applicable
Include criteria1) 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.
Exclude criteria1) 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.

Related Information


Public contact
Name Yasushi Hada
Address 2-1-1 Amakubo,Tsukuba,Ibaraki Ibaraki Japan 305-8576
Telephone +81-29-853-3795
Affiliation University of Tsukuba Hospital
Scientific contact
Name Yasushi Hada
Address 2-1-1 Amakubo,Tsukuba,Ibaraki Ibaraki Japan 305-8576
Telephone +81-29-853-3795
Affiliation University of Tsukuba Hospital