NIPH Clinical Trials Search

Effects of Hip-type Hybrid Assistive Limb (HAL)

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	spastic paraplegia, spinocerebellar degeneration, amyotrophic lateral sclerosis (ALS), or muscle dis
Date of first enrollment	24/02/2026
Target sample size	30
Countries of recruitment
Study type	Interventional
Intervention(s)	HAL Group: Short-term intensive intervention using the walking-type HAL lumbar type Implementation period: 5 days (5 consecutive days excluding weekends and holidays) Frequency: 1 session/day, Duration: 45 minutes/session (5-minute warm-up / 15-minute standing-up training / 20-minute walking training / 5-minute cool-down) Attachment sites: Thigh and lumbar region (4 channels: bilateral rectus femoris and gluteal muscles) Implementer: Physical therapist certified in HAL operation Control Group: Standard rehabilitation (physical therapy/occupational therapy) Range of motion training, stretching, activities of daily living training, gait training, balance training, etc., implemented according to the patient's condition

Outcome(s)

Primary Outcome

Comparison of changes in TUG (Timed Up and Go) test between the 5-day immediate HAL intervention group and the standard rehabilitation group, measured before and after implementation

Secondary Outcome

Changes in the 30-second Chair Stand Test (CS-30), 10-meter Walk Test, and Short Physical Performance Battery (SPPB) Disease-specific evaluation scales (Modified Ashworth Scale, Scale for Assessment and Rating of Ataxia SARA, ALS Functional Rating Scale-Revised :ALSFRS-R, IBM Functional Rating Scale :IBM-FRS, GNE Myopathy Functional Activity Scale :GNEM-FAS) Patient-reported outcomes (Barthel Index, SF-36, walking ability, Visual Analog Scale (VAS) for difficulty in standing up) Safety evaluation (frequency and severity of adverse events, changes in vital signs, fatigue level, skin condition)

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	<= 85age old
Gender	Both
Include criteria	1. Individuals who have provided written informed consent for research participation 2. Males and females aged 20 to 85 years at the time of consent 3. Individuals with a confirmed diagnosis of spastic paraplegia, spinocerebellar degeneration, amyotrophic lateral sclerosis (ALS), or muscle disease 4. Individuals who can maintain standing position for at least 10 seconds with assistance or support 5. Individuals who experience difficulty with toilet activities or short-distance walking 6. Individuals who can perform the Timed Up and Go (TUG) test 7. Patients who can be hospitalized for 2 weeks 8. Both patients who have not undergone rehabilitation and those currently undergoing standard rehabilitation
Exclude criteria	1) Individuals with severe skin diseases or pressure ulcers at the lumbar area where HAL is worn or at electrode attachment sites 2) Individuals whose body size is outside the applicable range of HAL (body weight less than 40 kg or exceeding 80 kg, height less than 140 cm or exceeding 180 cm), or individuals whose thigh circumference, abdominal circumference, or waist width required for HAL attachment is outside the applicable range 3) Individuals with severe cardiac diseases (heart failure of NYHA class III or higher, unstable angina, etc.) 4) Individuals with severe respiratory diseases (oxygen saturation less than 90% at rest) 5) Individuals with cognitive impairment who have difficulty understanding instructions 6) Pregnant women, women who may be pregnant, or lactating women 7) Individuals with a history of lower limb fracture within the past 3 months 8) Individuals with dosage changes in antispasticity medications within 4 weeks prior to study initiation 9) Patients with severe osteoporosis 10) Patients with poorly controlled epilepsy 11) Patients with severe joint contractures 12) Patients with a history of deep vein thrombosis or at high risk for deep vein thrombosis 13) Any other individuals deemed inappropriate for enrollment in the study by the principal investigator