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Effect of Overground Gait Training using a Torque-Assisted Exoskeletal Wearable Device on Ambulatory Function in Subacute Stroke Patients, Multi-Center, Randomized Single-blinded Controlled Prospective Pilot Study

Effect of Overground Gait Training using a Torque-Assisted Exoskeletal Wearable Device on Ambulatory Function in Subacute Stroke Patients, Multi-Center, Randomized Single-blinded Controlled Prospective Pilot Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0006815
Enrollment
150
Registered
2021-12-07
Start date
2021-12-01
Completion date
Unknown
Last updated
2022-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Others(Torque-Assisted Exoskeletal Wearable Device) : - First of all, patients who meet the inclusion criteria are randomized between the robot-assisted training group and the control group, through b
five sessions a week for four weeks. The robot-assisted training group is given 30 min conventional gait training and another 30 min (excluding robot attachment and detachment time) gait training usin

Sponsors

Yonsei University Health System, Severance Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: ? patients with significant difficulty in communication, such as severe cognitive impairment (MMSE <10) or speech-language impairment ? patients with ataxia ? patients with spasticity of the affected lower extremity of measured by Modified Ashworth scale (Modified Ashworth Scale (MAS) = 2) ? patients with severe musculoskeletal disorder in the lower limbs ? patients with a contracture that limits the lower limb range of motion ? patents with apparent leg length discrepancy of 2 cm or more (Rt: cm / Lt: cm) ? patients with a lower limb fracture or open wound or unhealed ulcer ? patients to whom robot-assisted gait rehabilitation cannot be applied due to a severe cardiovascular or pulmonary disease ? patients with a history of osteoporotic fracture ? patients with a neurological disorder that may affect the ambulatory function (e.g. Parkinson disease, multiple sclerosis, etc.) ? patients determined to be ineligible by the investigator

Exclusion criteria

Exclusion criteria: ? patients who express a desire to drop out of treatment ? patients who do not comply with the guidelines provided by the investigator ? patients who require a treatment outside the scope of the present clinical study ? patients who show a severe injury due to an accident such as a fall ? patients who participate in < 80% of training sessions ? patients who show a new major condition and consequently require absolute rest for recovery (e.g. another incidence of stroke, aggravation of stroke, myocardial infarction, any other neurological, internal, or musculoskeletal condition, etc.)

Design outcomes

Primary

MeasureTime frame
Functional Ambulatory Category (FAC)

Secondary

MeasureTime frame
Fugl Meyer Assessment-Lower Extermity;10 Meter Walking Test (10MWT);6 Minute Walking Test;Physiological cost index;Berg Balance Score (BBS);Trunk Control Test (TCT);Functional Independence Measure (FIM);Modified Ashworth Scale;Motricity index-Lower Extremity;Geriatric depression scale-short form (GDS-SF)

Countries

Korea, Republic of

Contacts

Public ContactDaehyun Kim

Yonsei University Health System, Severance Hospital

hohoho7490@yuhs.ac+82-2-2228-3724

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 8, 2026