Children With Spinal Cord Disorders and Gait Impairment
Conditions
Interventions
The HAL lower-limb intervention will be conducted once per day for 30 minutes, 1 to 4 times per week (for a total of 12 sessions). A session will be considered valid if at least 15 minutes are complet
sessions lasting less than 15 minutes will not be counted. The intervention program aims to improve walking ability and consists of sit-to-stand training, standing training, and gait training using HA
Sponsors
Marushima Aiki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients whose legal representative can provide written informed consent. 2) Patients aged 5 to 15 years. 3) Patients who are at least 12 months post-onset. 4) Patients classified as Frankel grade C or D, or Sharrard grade 1 - 4. 5) Patients who are able to walk a distance of 10 meters (with walking aids permitted). 6) Patients who can be fitted with HAL size S or 2S. 7) Patients who can remain hospitalized or attend outpatient visits according to the study schedule during the research period.
Exclusion criteria
Exclusion criteria: 1) Patients who have impaired consciousness or severe intellectual disability that makes it difficult to perform voluntary limb movements in response to instructions. 2) Patients with severe skeletal deformities - such as osteoarthritis, spondylosis deformans, or scoliosis - that make joint-movement training or HAL fitting difficult. 3) Patients with comorbidities that may interfere with training, such as bleeding tendencies or osteoporosis. 4) Patients who cannot have HAL bioelectrodes applied due to skin diseases or related conditions. 5) Patients who have participated in another study within 12 weeks prior to the start of this clinical research. 6) Patients judged as unsuitable for participation in this study by the principal investigator or sub-investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-minute walk test | — |
Secondary
| Measure | Time frame |
|---|---|
| 10-Meter Walk Test (self-selected walking speed) Walking Index for Spinal Cord Injury II (WISCI-II) Lower Extremity Motor Score (LEMS) Modified Ashworth Scale (MAS) Trunk Activity Scale for Spinal Cord Injury (TASS) Canadian Occupational Performance Measure (COPM) Japanese Version of the Decision Regret Scale (Japanese DRS) Changes in lower-limb joint angles during gait Changes in lower-limb muscle activity during gait | — |
Contacts
Public ContactKazushi Takahashi
University of Tsukuba
Outcome results
None listed