Exercise therapy for MADS with HAL lumbar type

Exercise therapy for musculoskeletal ambulation disability symptom complex (MADS) with lumbar type HAL: safety and feasibility study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs032200234

Enrollment

Registered

2020-12-08

Start date

2021-08-09

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Musculoskeletal ambulation disability symptom complex

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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 100 years

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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).	—

Measure

Time frame

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).

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Contacts

Public ContactKousei Miura

University of Tsukuba Hospital

kmiura@tsukuba-seikei.jp+81-29-853-3219

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026