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The effect of gait training combined with transcutaneous electrical nerve stimulation in stroke

A randomized, single-center, single-blinded, a researcher clinical trial to evaluate the effect on gait performance of gait training combined with transcutaneous electrical nerve stimulation in chronic stroke

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0008481
Enrollment
24
Registered
2023-05-31
Start date
2023-05-22
Completion date
Unknown
Last updated
2023-06-26

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 (n=24) are randomly assigned to continuous TENS group (n=8), periodic TENS group (n=8) and sham stimulation group (n=8). All groups receive treatment 3 times per week for

Sponsors

Chonnam National University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients aged from 20 to 90 years 2) 6 months after stroke onset 3) hemiplegic patient 4) Functional ambulatory category grade 2~4 5) No difficulty in understanding and communicating with physical therapist 6) Who voluntarily signed an informed consent form for participation in clinical trial

Exclusion criteria

Exclusion criteria: 1) Who has gait and balance disturbance due to disease other than stroke (e.g. Parkinsonism, neuropathy, myopathy, arthropathy) 2) Who has medical and surgical condition at electrode attachment site (e.g. severe arterial circulatory disease of lower extremities) 3) Unstable vital signs 4) Who get ongoing treatment for malignancy 5) Who has severe depression and psychiatric disorders that is difficult to adapt the treatment 6) Who has pacemaker, defibrillator, neurostimulator, drug pump, intracardiac injection line 7) Who has experienced a seizure or get ongoing treatment for epilepsy 8) Who has difficulty in communication due to severe aphasia 9) Who has cognitive decline that is difficult to adapt the treatment (Clinical Dementia Rating 1 or more) 10) Who received medication, procedure or surgery that may affect gait function in last 1 month 11) Who received medication, procedure or surgery that may affect gait function within the study period 12) Pregnant or breast-feeding woman 13) Who are enrolled in other clinical trials 14) Who cannot understand the purpose of the clinical trial or perform treatment protocol 15) Who is thought to be inappropriate to participate in the clinical trial

Design outcomes

Secondary

MeasureTime frame
MMT(Manual muscle test);TUG(Timed up and go test);FAC(Functional Ambulatory Category);BBS(Berg balance test);K-MBI(K-Modified Barthel Index);European Quality of Life Five Dimension (EQ-5D-3L);Gait analysis

Primary

MeasureTime frame
10-meter walking test

Countries

Korea, Republic of

Contacts

Public ContactLee Jin-Seon

Chonnam National University Hospital

ljs2159@naver.com+82-62-220-5186

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026