Clinical trial NCT06549127: Research on Clinical Safety and Effectiveness of Wearable Assistive Devices With Flexible Structure for Daily Life Support of Stroke Patients
Official title: Research on Clinical Safety and Effectiveness of Wearable Assistive Devices With Flexible Structure for Daily Life Support of Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Hemiplegia
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2024-08-12
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Gait independence is a critical goal for stroke patients and significantly impacts their return to society. Due to hemiplegia, stroke patients often face walking difficulties. Compensatory approaches using lower limb assistive devices have shown promise in improving independent walking. Wearable assistive devices, which minimize daily life restrictions, are gaining attention globally. Despite the availability of many imported rehabilitation assistive devices, their high cost and poor fit for East Asian patients highlight the need for domestic alternatives. In light of the global interest in robotics, there is a shortage of domestic research on advanced wearable robots. This study aims to clinically test and verify the effectiveness of a flexible, wearable robotic assistive device developed by Angel Robotics for stroke patients.

Detailed description: The study will enroll 20 participants, providing knee and hip assistance during overground walking adaptation training. Participants will undergo an initial assessment followed by three 30-minute sessions of training with a powered hip assistive device over two weeks. Post-intervention Assessment 1 will follow this training. Then, participants will undergo three 30-minute sessions of training with a powered knee assistive device over the next two weeks, followed by Post-intervention Assessment 2. Each participant will have nine visits in total, including three functional assessments and six adaptation training sessions. The schedule for subsequent visits will be arranged during the first visit. The familiarization process will be conducted two to three times per week, adjusted for participants' convenience, with each set of three visits completed within three weeks. Trained therapists will handle the attachment and adjustment of the powered assistive devices.

Assessments will be conducted at three points: before the first training session, after the third session, and after the sixth session. Measurements will be taken under three conditions: without the assistive device, with the assistive device but without power assistance, and with the assistive device and power assistance, in random order.

This study will evaluate the following: Gait speed using the 10-meter walk test, Walking distance using the 6-minute walk test, 3D gait analysis (Human body model) assessing kinetics and kinematics, Energy consumption, including oxygen rate (VO2/ml/min per kg of body weight) and oxygen cost (oxygen rate per walking speed in m/min), Lower limb strength and motor function, assessed by the Functional Ambulatory Category (gait independence), Berg Balance Test (balance ability), and Rivermead Mobility Index (motor ability), These evaluations will help determine the effectiveness of the wearable robotic assistive device in aiding the gait of stroke patients.

Eligibility criteria: Inclusion Criteria:

* 1. Adult patients aged 19 years and older 2. Diagnosed with stroke confirmed by neurologists or neurosurgeons through imaging techniques such as CT or MRI 3. Chronic hemiplegic stroke patients, 6 months or more post-stroke onset 4. Patients with a Functional Ambulatory Category (FAC) score of 3 or higher 5. Patients with a Mini-Mental State Examination (MMSE) score of 10 or higher, who can understand the study, have a voluntary willingness to participate, and have given consent to participate

Exclusion Criteria:

* 1. Acute/subacute stroke patients within 6 months of stroke onset 2. Quadriplegia 3. Ataxia 4. Severe lower limb joint contractures that make wearing the assistive device difficult 5. Patients with neurological, musculoskeletal, or cardiopulmonary diseases that affect walking 6. Any other conditions deemed inappropriate for participation in the study by the researcher

Primary outcomes:
measure: 10-meter walking test
timeFrame: Initial Assessment
measure: 10-meter walking test
timeFrame: After 2 weeks of hip assistive device adaptation training
measure: 10-meter walking test
timeFrame: After 2 weeks of knee assistive device adaptation training
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine
Study officials:
References: