Trunk and lower limb impairment due to spinal cord injury in individuals aged 16 years or older Trunk impairment
Conditions
Interventions
Active standing training using Qolo for spinal cord injury patients with trunk and lower limb impairment
Standing training
Sponsors
Hada Yasushi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Individuals between 2 weeks and less than 1 year after spinal cord injury onset 2) Patients with spinal cord injury-related trunk and lower limb impairments with standing difficulty 3) Patients capable of sitting balance training in conventional physical therapy 4) Patients who meet the physical requirements for wearing Qolo (body weight: 40-100 kg, height: equivalent to 145-190 cm) 5) Patients who have received sufficient explanation about the purpose and methods of the study and have provided written informed consent (proxy signature acceptable) 6) Patients aged 16 years or older (for those under 18 years, consent from a parent or guardian is required)
Exclusion criteria
Exclusion criteria: 1) Cognitive or severe communication impairment preventing instruction compliance 2) Unstable vital signs (e.g., acute cardiovascular disease, stroke, severe arrhythmia, acute infection) 3) Physical conditions unsuitable for Qolo use (e.g., severe contractures, marked skeletal deformities) 4) Deemed unsafe by the principal or sub-investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Trunk Assessment Scale for Spinal Cord Injury (TASS) scores between pre- and post-intervention during the Qolo standing training period | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in TASS scores between baseline and mid-intervention assessment during Qolo standing training period Incidence of adverse events Changes in vital signs (blood pressure, pulse rate, oxygen saturation, etc.) Subjective exercise intensity (Modified Borg Scale) TASS score changes: baseline to mid-intervention, mid-intervention to post-intervention Standing-related parameters (number of standing repetitions, standing duration, Qolo assist level) Sitting tolerance time Neurological assessment: ISNCSCI Motor Score, AIS classification, neurological level of injury Activities of daily living: SCIM-III, FIM Physical function: spasticity (Modified Ashworth Scale), range of motion QOL measures: EQ-5D-5L, Japanese version of Decision Regret Scale Surface electromyography, muscle thickness (ultrasound), questionnaire survey | — |
Contacts
Public ContactYukiyo Shimizu
University of Tsukuba Hospital
Outcome results
None listed