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

JRCT ID: jRCTs042230090

Registered date:17/10/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Spinal cord injury patients who fall into the subacute or maintenance phase
• Date of first enrollment: 17/10/2023
• Target sample size: 30
• Study type: Interventional

Intervention(s)

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. If consent for the study is obtained, a pre-intervention evaluation will be conducted after obtaining written consent, and subjects who meet the selection criteria and who do not meet the exclusion criteria will be enrolled as subjects.
3. Measurements of the lower limbs will be taken, fitting adjustment of the WPAL will be made, and practice will begin.
4. The difficulty level of the WPAL will be increased when the subject meets the specified conditions, in the following order: treadmill practice, walking practice on the parallel bars, walking practice on the treadmill, and walking practice with a walker, in order to gain proficiency in the WPAL. In the same way, the user's stride, cadence, and other gait conditions are also increased according to the user's gait ability to achieve proficiency. The duration of each practice session will be 60 minutes, and outpatients will practice 1 to 4 times a month, and inpatients will practice 1 to 7 times a week until the end of the study period.
5. Evaluation of the effectiveness and safety of the WPAL intervention will be conducted for up to 5 years according to the established schedule, and changes over time and the relationship with each item will be verified.

Outcome(s)

• Primary Outcome: Health-related quality of life

Secondary Outcome

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)

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: < 80age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Otaka Yohei
• Secondary Sponsor: Hirano Satoshi