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The therapeutic effects of peroneal nerve functional electric stimulation for lower extremity in patients with sub-acute post-stroke hemiplegia: A randomized controlled study(RALLY Study)

The therapeutic effects of peroneal nerve functional electric stimulation for lower extremity in patients with sub-acute post-stroke hemiplegia: A randomized controlled study(RALLY Study) - RALLY study

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000020604
Enrollment
200
Registered
2016-01-17
Start date
2016-08-01
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

Stroke

Interventions

Gait training with functional electrical stimulation (FES) + conventional rehabilitation therapy. Intervention with FES is scheduled 40min/day, five times a week, for 8 weeks. Gait training without f

Sponsors

Kagoshima University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Patinets who agree to participate in this study and provode their informed consent; (2) since after stroke wothin 6 months; (3) stroke type is only intracranial hemorrhage or ischemic stroke; (4) inpatients for the rehabilitation therapy; (5) Functional Ambulation Classification (FAC) is 3 or 4; (6) stable general condition; (7) drop foot in walking

Exclusion criteria

Exclusion criteria: (1) severe heart disease; (2) previous gait disability, such as neurological disease; (3) previous orthopedic disease, such as knee osteoarthritis; (4) severe hepatic or renal dysfunction; (5) severe sensory disturbance or severe ataxia or severe higher brain dysfunction; (6) contraindicated for the electrical stimulation (e.g. patients with a medical implant or implantable medical electrical equipment such as a cardiac pacemaker); (7) severe skin disease; (8) unstable medical condition; (9) patinets whose impairement severlities changed during the study period

Design outcomes

Primary

MeasureTime frame
6-minute walk test at baseline and ater 8-week intervention

Secondary

MeasureTime frame
10-m walk test; Fugl-Meyer assessment (FMA); modified Ashworth scale (MAS); range of motion; Timed up and go test (TUG); Stroke Impact Scale (SIS); subjective gait analysis; Patient reported outcome measure (PRO), adverse event

Countries

Japan

Contacts

Public ContactShuji Matsumoto

Kagoshima University Dept. of Rehabilitation

shushu@m.kufm.kagoshima-u.ac.jp0995-78-2538

Outcome results

None listed

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