Exercise therapy using lumbar type HAL for patients with disuse syndrome

JRCT ID: jRCTs032220541

Registered date:26/12/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: disuse syndrome
• Date of first enrollment: 05/04/2023
• Target sample size: 60
• Study type: Interventional
• Intervention(s): Rehabilitation consisting of (1) forward bending training, (2) pelvic tilt training, (3) standing training, and (4) squat training using HAL waist type for a total of 10 sessions of 15 minutes per session (not including time for dressing and undressing) 5 times a week for 2 weeks.

Outcome(s)

Primary Outcome

Efficacy of Exercise Therapy Using HAL Waist Type
Percentage of responders whose Timed Up and Go test (TUG) was shortened by 3.4 seconds or more at the end of exercise therapy compared to before the start of exercise therapy.

Secondary Outcome

Mobility function (Barthel index (BI), five times stand test (SS-5), Functional Independence Measure (FIM)) was evaluated before the study, at the end of the study, and at follow-up (1 week and 2 weeks after the end of exercise therapy) by exercise therapy intervention using HAL waist type. Mobility function (Barthel index (BI), five-stance test (SS-5), and Functional Independence Measure (FIM)) were assessed before, at the end of, and at follow-up (1 week and 2 weeks after the end of exercise therapy) using TUG and HAL waist type exercise therapy intervention. The patients were evaluated before the start of the study, at the end of the study, and at the follow-up (1 week and 2 weeks after the end of exercise therapy).
Evaluation of treatment effect by underlying disease
Safety of exercise therapy using HAL hip type for disuse syndrome (evaluation of the occurrence of diseases during the exercise therapy as follows)
(1) The occurrence of other illnesses, etc.

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: <= 100age old
• Gender: Both

Include criteria

(1) Persons admitted to the Community Comprehensive Care Unit
(2) Persons who can give written consent of their own free will
(3) Men and women between the ages of 65 and 100
(4) Persons with disuse syndrome at or above the level of sitting assistance (FIM transfer operation 3-5 as a guide)
5) Persons who can wear HAL waist type. (Height about 140 to 180 cm, Weight about 40 to 80 kg, Abdominal circumference 120 cm or less, Mid-thigh circumference 80 cm or less, Pelvic width 39 cm or less)

Exclude criteria

1) Persons using active implanted medical devices such as cardiac pacemakers
2) Patients with serious complications for which exercise therapy is not indicated. For example, heart failure with oxygen administration, respiratory failure, ischemic heart disease with symptoms, non-compensated liver cirrhosis, poorly controlled diabetes, hypertension, etc.
(3) Patients who have difficulty making free-will decisions to participate or not participate in the research due to impaired consciousness, severe dementia, etc., or who have difficulty performing effective exercise therapy.
(4) Persons who are unable to apply HAL bioelectrodes due to skin diseases, etc.
(5) Other patients whom the principal investigator or subinvestigator determines to be inappropriate to participate in this study.

Related Information

• Primary Sponsor: Miura Kousei
• Source(s) of Monetary Support: University of Tsukuba Hospital