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Effects of a Soft Wearable Robotic Suit on Gait Training in Adults with Cerebral Palsy: An Exploratory Randomized Controlled Trial

Effects of a Soft Wearable Robotic Suit on Gait Training in Adults with Cerebral Palsy: An Exploratory Randomized Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0012284
Enrollment
40
Registered
2026-07-15
Start date
2026-05-12
Completion date
Unknown
Last updated
2026-07-20

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 : Participants who complete the baseline assessment will undergo either 10 sessions of gait rehabilitation training using the hip-extension-assisting soft wearable robotic suit (1–2 tim

Sponsors

Yonsei University Health System, Severance Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: ? Adults aged 19 years or older ? Patients diagnosed with cerebral palsy ? Patients with a gait function score of 1 or higher as assessed by the Functional Ambulation Category (FAC) ? Individuals capable of safely wearing and utilizing the soft wearable robotic suit with minimal assistance ? Height between 140 cm and 190 cm ? Individuals who have obtained approval for study participation from their attending medical staff

Exclusion criteria

Exclusion criteria: ? Cognitive impairment that leads to difficulty understanding the study procedures or an inability to follow the researcher’s instructions ? Presence of fractures, open wounds, or unhealed ulcers in the lower extremities ? Severe medical conditions, such as cardiovascular or pulmonary diseases, that pose difficulties in undergoing gait training ? Presence of other neurological disorders that affect gait ? Any other condition that, in the opinion of the investigator, renders the participant unsuitable for this study ? Pregnant or lactating women (verified through participant interview) ? Refusal to participate in the study

Design outcomes

Primary

MeasureTime frame
Changes in balance ability measured by Berg Balance Scale (BBS)

Secondary

MeasureTime frame
Changes in gait speed measured by the 10-Meter Walk Test (10MWT);Changes in walking endurance (distance) measured by the 6-Minute Walk Test (6MWT);Changes in dynamic balance and mobility (execution time) measured by the Timed Up and Go (TUG) test;Changes in Activities of Daily Living (ADL) performance measured by the Modified Barthel Index (MBI);Changes in functional independence measured by the Functional Independence Measure (FIM);Changes in skeletal muscle mass measured by bioelectrical impedance analysis (InBody);Change in Short Physical Performance Battery (SPPB) score;Changes in psychosocial-emotional indicator scores following robot-assisted gait training;Changes in cadence following robot-assisted gait training;Changes in gait speed following robot-assisted gait training;Changes in stride length following robot-assisted gait training;Changes in swing ratio following robot-assisted gait training

Countries

Korea, Republic of

Contacts

Public ContactYoolim Lee

Yonsei University Health System, Severance Hospital

lul421@naver.com+82-2-2228-3776

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Jul 23, 2026