Home-based robotic gait rehabilitation for stroke patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness and safety of a wearable exoskeletal robot designed for at-home gait rehabilitation in stroke patients. Participants will undergo 10 sessions of robotic-assisted gait training over four weeks, focusing on improving walking speed, body composition, gait patterns, and balance. The study will compare pre- and post-intervention assessments, including various physical function tests and participant satisfaction surveys, to determine the impact of the intervention. No control group will be established, and device malfunctions will be documented and addressed.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. adults aged 19 to 79 years (based on the age on their national ID at the time of consent)
2. individuals diagnosed with cerebral infarction or intracerebral hemorrhage confirmed by MRI or CT.
3. patients who have passed at least one month since stroke diagnosis.
4. individuals exhibiting spastic hemiplegic gait patterns due to stroke.
5. patients with a Functional Ambulatory Category score of less than 4.
6. individuals who can sit on the edge of a bed without assistance and stand for 10 seconds with or without assistance.
7. individuals with sufficient cognitive ability to follow simple instructions and understand the study's content and purpose (Mini-Mental State Examination score \>= 20)

Exclusion Criteria:

1. individuals with severe joint contractures or osteoporosis, or untreated fractures that contraindicate weight-bearing on the lower limbs.
2. individuals with skin conditions or open wounds that prevent device usage.
3. individuals with significant differences in leg length.
4. individuals with severe deformities or joint contractures in the lower limbs.
5. individuals at high risk of fractures due to conditions like osteoporosis.
6. individuals unable to maintain a sitting or standing position independently.
7. individuals with severe lower limb spasticity (Modified Ashworth Scale grade 2 or higher).
8. individuals with severe cognitive impairment (Mini-Mental State Examination score \< 20), delirium, or severe language impairment that hinders cooperation with wearable exoskeletal robot gait training.
9. individuals unable to maintain prolonged standing or walking due to conditions like orthostatic hypotension or cardiopulmonary impairment.
10. individuals with conditions affecting gait, such as peripheral neuropathy, Parkinsonism, or those with alcohol dependence or severe diabetes.
11. pregnant women or those who could become pregnant.
12. individuals participating in other clinical trials.
13. individuals at high risk of falls or bleeding due to conditions like coagulopathies.
14. individuals shorter than 140 cm, taller than 190 cm, or weighing over 80 kg.
15. individuals with other clinical findings deemed inappropriate for the study by the principal investigator or study coordinator.

Where it's running

• Yongin Severance Hospital
  Yongin-si, Gyeonggi-do, South Korea Recruiting

Study contacts

• Principal investigator: Na Young Kim, MD, PhD — Severance Hospital
• Study coordinator: Na Young Kim, MD, PhD
• Email: kny8452@yuhs.ac
• Phone: +82 010 9127 4482

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Remote Ischaemic Conditioning for Fatigue After Stroke 2

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.