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Effect of gait training using Welwalk and Botulinum Toxin A Injection on gait ability in chronic stroke patients

Effect of gait training using Welwalk and Botulinum Toxin A Injection on gait ability in chronic stroke patients - Combined effects of gait training using Welwalk and Botulinum Toxin A Injection in chronic stroke patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000048477
Enrollment
20
Registered
2022-07-27
Start date
2022-12-01
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

Chronic stroke patients

Interventions

Gait exercise using Welwalk after botulinum toxin type A therapy (40 min/day, 5 days/week for 4 weeks) Botulinum Toxin A Injection alone

Sponsors

Hyogo medical university
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.>6 months duration after stroke 2.Hemiparesis and spasticity due to ischemic or hemorrhage on the unilateral tent (lower extremity modified Ashworth Scale of more than 1+) 3.Independent in ground ambulation with or without the use of a unilateral assistive device (standard cane, four-pronged cane) and with or without the use of a an ankle foot orthoses. 4.Independent in treadmil gait training 5.Approval for study participation

Exclusion criteria

Exclusion criteria: 1.Cannot obey instructions of a healer (scores < 23 on the Mini Mental Status examination, etc) 2.Significant cardiorespiratory/metabolic disease, or orthopedic injury or other neurological 3.Excessive spasticity (defined as modified Ashworth scale 4 at any lower limb joint) 4.Size limitations for the harness/counterweight system or robotic orthosis 5.Receiving anti-spasticity therapy (Botulinum Toxin A, phenol, baclofen pump, etc.) in the lower extremities within 16 weeks of study entry

Design outcomes

Primary

MeasureTime frame
Gait analysis

Secondary

MeasureTime frame
Range of motion (knee, ankle) Modified Ashworth Scale (MAS) 10m gait velocity 6-minute walk distance Timed up to Go Global rating of change scale MOS Physical Cost Index8-Item Short-Form Health Survey Physical Cost Index Physical activity electromyogram of the lower limb

Countries

Japan

Contacts

Public ContactTomoyuki Ogino

Hyogo medical university School of Rehabilitation

to-ogino@hyo-med.ac.jp078-304-3184

Outcome results

None listed

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