Effects of a Soft Wearable Robotic Suit on Gait in Hemiparetic Patients with Stroke: An Exploratory Pilot Randomized Controlled Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0011918

Enrollment

Registered

2026-04-29

Start date

2026-05-11

Completion date

Unknown

Last updated

2026-05-04

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

Conditions

None listed

Interventions

Medical Device : The intervention consists of 20-minute treadmill walking sessions per session. Participants in the intervention-group will perform treadmill walking while wearing a soft-wearable robo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with gait disturbance, who have been diagnosed with hemiplegic stroke within 6 weeks of onset and are currently hospitalized 2. Patients with a gait function score of 3 or higher as assessed by the Functional Ambulation Category (FAC).

Exclusion criteria

Exclusion criteria: 1. Patients with cognitive impairment (MMSE < 24). 2. Patients with cerebellar ataxia causing balance and gait disturbances. 3. Patients with cardiopulmonary conditions that contraindicate exercise. 4. Patients with neuromuscular comorbidities resulting in muscle weakness. 5. Patients with other major neurological disorders in addition to stroke (e.g., spinal cord injury, Parkinson’s disease). 6. Patients with major psychiatric disorders requiring continuous medication, such as major depressive disorder, schizophrenia, bipolar disorder, or dementia. 7. Patients deemed inappropriate for participation by the investigator for any other reason.

Design outcomes

Primary

Measure	Time frame
Functional Ambulatory Category, FAC;Gait speed (10-meter Walk Test, 10MWT);6-Minute Walk Test, 6MWT	—

Secondary

Measure	Time frame
Berg Balance Scale, BBS;Timed Up and Go Test (TUG);modified Rankin Scale, mRS;Korean version of Modified Barthel Index, K-MBI;Fugl-Meyer Assessment, FMA;Korean version of Mini Mental State Examination, K-MMSE;Korean version of Montreal Cognitive Assessment, K-MoCA;Motor Evoked Potential, MEP;Bone mineral density, BMD;Spatio-temporal gait parameters (Range of Motion -ROM- of lower limb joints, Step width, Step length, Stride length, Number of steps, Gait speed, Pelvic tilt, Center of mass);Safety analyses	—

Measure

Time frame

Berg Balance Scale, BBS;Timed Up and Go Test (TUG);modified Rankin Scale, mRS;Korean version of Modified Barthel Index, K-MBI;Fugl-Meyer Assessment, FMA;Korean version of Mini Mental State Examination, K-MMSE;Korean version of Montreal Cognitive Assessment, K-MoCA;Motor Evoked Potential, MEP;Bone mineral density, BMD;Spatio-temporal gait parameters (Range of Motion -ROM- of lower limb joints, Step width, Step length, Stride length, Number of steps, Gait speed, Pelvic tilt, Center of mass);Safety analyses

—

Countries

Korea, Republic of

Contacts

Public ContactHo Seok Lee

Chung-Ang Univerisity Hospital

hoseoklee@cauhs.or.kr+82-2-6299-1871

Outcome results