Effects of combined active pedaling exercise with electrical stimulation on gait disturbance in patients with stroke - A single-blind randomized control study, multicenter trial -.

Effects of combined active pedaling exercise with electrical stimulation on gait disturbance in patients with stroke - A single-blind randomized control study, multicenter trial -. - Effects of combined pedaling exercise with electrical stimulation

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007685

Enrollment

Registered

2012-04-15

Start date

2012-04-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Post-stroke patients

Interventions

Combination of pedaling exercise with electrical stimulation 15min/day for 3weeks. Combination of pedaling exercise with sham electrical stimulation 15min/day for 3weeks. Electrical stimulation alone1

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: First episode of unilateral hemiparetic stroke occurring within the six-month period prior to enrolment, age between 30 and 75 years, Functional Ambulation Categories13 score greater than 3 (ambulator-dependent for supervision);, modified Ashworth scale14 score greater than 1 (slight increase in muscle tone) for the affected side ankle dorsiflexors, no severe cognitive impairment (Mini-Mental State Examination: MMSE>21

Exclusion criteria

Exclusion criteria: Unstable medical disorder, implanted electronic pacing or defibrillation devices, unstable vital signs, or potentially fatal cardiac arrhythmias. Marked sensory deficit in the affected lower extremity. Fugl-Meyer lower extremity items >32. Gait velocity <57m/min.

Design outcomes

Primary

Measure	Time frame
10m gait measurement	—

Secondary

Measure	Time frame
2 minute or 6 minute walk test, Time up and Go test (TUG), Functional Ambulation Categories (FAC), modified Ashworth scale (MAS), Brunnstrom-stage, Fugl-Meyer assessment, grip strength, knee extension strength, Functional Independence Measure (FIM), Stroke Impact Scale (SIS)-16	—

Countries

Japan

Contacts

Public ContactKoki Ikuno

Nishiyamato Rehabilitaiton Hospital Department of Rehabilitation Medicine

k.ikuno@gmail.com0745-71-6688

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026