Study on the effects of standing and walking practice using WPAL (Wearable Power-Assist Locomotor) on the quality of life and the secondary health conditions of people with spinal cord injury

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs042230090

Enrollment

Registered

2023-10-17

Start date

2023-10-17

Completion date

Unknown

Last updated

2025-07-18

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

Conditions

Spinal cord injury patients who fall into the subacute or maintenance phase Tetraplegia, paraplegia

Interventions

1. The principal investigator or a subinvestigator will provide sufficient explanation to the research subjects or their surrogates about the content of this research and the equipment to be used. 2.

D012046

Rehabilitation, Exoskeleton

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Who have obtained written consent to participate in this study from the individual or his/her proxy or surrogate. 2. Whose age is between 16 and 80 years old. 3. Spinal cord injury patients undergoing WPAL in the subacute and maintenance phases. (Includes paraplegics and quadriplegics due to myelitis or spinal cord infarction. Also included are those who have already undergone WPAL.) 4. Who are between 155 cm and 180 cm in height. 5. Weighs less than 80 kg.

Exclusion criteria

Exclusion criteria: 1. People with acute spinal cord injury. 2. Patients with dementia and impaired consciousness who have difficulty communicating. 3. Patients with easily fractured vertebrae and extremities. 4. Patients with significant contractures or heterotopic ossification of the spine or limbs. 5. Patients with pressure ulcers that interfere with robotic application. 6. Patients with cardiovascular or respiratory disease that makes exercise therapy difficult. 7. Patients with uncontrolled hypertension. 8. Pregnant patients or patients who may be pregnant. 9. Who have an infectious disease that requires isolation. 10. Patients with urinary or fecal incontinence to the extent that the WPAL is contaminated. 11. Patients who are deemed inappropriate by the attending physician, principal investigator, or research assistants.

Design outcomes

Primary

Measure	Time frame
Health-related quality of life	—

Secondary

Measure	Time frame
Joint range of motion (hip extension, knee extension, ankle dorsiflexion) Spasticity (Modified Ashworth Scale) Pain (Numerical Rating Scale) Bowel function (Constipation Scoring System) ASIA impairment scale (including neurological level, UEMS, LEMS) Body composition (InBody) and weight Bone density (DEXA or ultrasound) Walking ability (Stride, Cadence, Functional Ambulation Categories, subjective fatigue while walking (modified Borg scale), walking distance and time per walk, maximum continuous walking distance and time per walk)	—

Measure

Time frame

Joint range of motion (hip extension, knee extension, ankle dorsiflexion) Spasticity (Modified Ashworth Scale) Pain (Numerical Rating Scale) Bowel function (Constipation Scoring System) ASIA impairment scale (including neurological level, UEMS, LEMS) Body composition (InBody) and weight Bone density (DEXA or ultrasound) Walking ability (Stride, Cadence, Functional Ambulation Categories, subjective fatigue while walking (modified Borg scale), walking distance and time per walk, maximum continuous walking distance and time per walk)

—

Contacts

Public ContactSatoshi Hirano

Fujita Health University Hospital

sshirano@fujita-hu.ac.jp+81-562-93-2167

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026