Exercise therapy for MADS with HAL lumbar type

JRCT ID: jRCTs032200234

Registered date:08/12/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Musculoskeletal ambulation disability symptom complex
• Date of first enrollment: 09/08/2021
• Target sample size: 60
• Study type: Interventional

Intervention(s)

Exercise training with the lumbar type HAL comprises sit-to-stand training, lumbar
flexion-extension training, and gait training. Repetitive sit-to-stand training with the
lumbar type HAL is performed for 10 min. After that, repetitive lumbar flexion and extension motion was performed for 5 min in a sitting position. Finally, gait training on the ground is performed continuously using the lumbar type HAL at a pace comfortable for the participant for 5 min. Each trainings are performed 2 times per week for 5 weeks.

Outcome(s)

Primary Outcome

Primary outcome: safety and feasibility
change of lumbar pain evaluated by visual analogue scale (>50% or >25 mm increase compared to baseline: adverse event); change of vital sign; newly development of disease related to exercise therapy with HAL lumbar type

Secondary Outcome

Secondary outcomes: efficacy
Completion rate of exercise therapy; Motor ability is assessed with a one-leg standing time (OLST), a 10-m walking test (10MWT), a Timed Up and Go test (TUG), 1-minute sit-to-stand test(1MSTS), mobility scores (locomotion and stair climb) from the Functional Independence Measure (FIM) assessment tool, and the number of affirmative answers on loco-check.; QOL is assessed using the EuroQOL-5d (EQ-5D) and EQ-Visual Analog Scale (EQVAS). ; Pain in locomotive organs is assessed using lumbar and limb visual analog scale scores (lumbar VAS and limb VAS). ; Cognitive function is assessed by MMSE and FAB.; Urinary function is assessed by International Prostate Symptom Score (IPSS).; Sleep function is assessed using Athens Insomnia Scale (AIS).

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

1) diagnosed musculoskeletal ambulation disability symptom complex
2) be able to obtain informed consent
3) suitable body size to fit the lumbar type HAL (maximum waist circumference, 120cm; maximum thigh circumference, 80 cm).
4) aged from 40 to 85 years

Exclude criteria

1) skin disorders prohibiting the attachment of the electrodes
2) inadequately controlled cardiovascular or respiratory disorders interfering with exercise therapy
3) severe dementia that prohibits understanding of the training program using HAL
4) medical history of lumbar spinal surgery
5) inadequate qualification judged by investigators to attend this trial

Related Information

• Primary Sponsor: Miura Kousei
• Source(s) of Monetary Support: Japan Society for the Promotion of Science