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

JRCT ID: jRCTs032230302

Registered date:22/08/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients with trunk and lower limb impariments who have difficulty standing
• Date of first enrollment: 23/10/2023
• Target sample size: 40
• Study type: Interventional
• Intervention(s): standing and stting training using Qolo

Outcome(s)

• Primary Outcome: 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

Secondary Outcome

Duration 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 maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Hada Yasushi