The efficacy of combination of botulinum toxin A and functional electrical stimulation in the treatment of upper limb flexor spasticity after stroke

The efficacy of combination of botulinum toxin A and functional electrical stimulation in the treatment of upper limb flexor spasticity after stroke - The efficacy of combination of botulinum toxin A and functional electrical stimulation in the treatment of upper limb flexor spasticity after stroke

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000015067

Enrollment

Registered

2014-10-01

Start date

2014-10-01

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

The combination group of botulinum toxin A injection and functional electrical stimulation Control group of only botulinum toxin A injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Neurology outpatinents who are treated with botulinum toxin A injection 2)Total injection volume of botulinum toxin A 200-240 units 3)Forearm injection of botulinum toxin A at least 50 units 4)Hemiplegia or monoplegia at least 6 months after stroke 5)Grade 3 as measured by the Modified Ashworth Scale 6)Upper limb flexor spasticity 7)Patients who can follow multi-step instructions 8)Patients who can read control unit 9)Patients who can fit FES instrument 10)Patients who can fit FES instrument by themselves or be fitted by family 11)Patients who can't extend complete fingers in a neutral position 12)Obtained informed consent

Exclusion criteria

Exclusion criteria: 1)Implanted medical electrical equipment including pacemaker 2)Skin lesion at electrode attachment 3)Infection or malignant tumor within upper limb 4)Pregnant woman 5)Patients who have metal implant or arteriovenous shunt for dialysis in the affected forearm and hand 6)Past history of seizure 7)Severe deformity of wrist or fingers 8)Severe limitation of ROM because of past fracture 9)Past history of neurological deficit derived from cervical spine or peripheral nerve 10)No adaptation to botulinum toxin A 11)Not obtained informed consent

Design outcomes

Primary

Measure	Time frame
Fugel-Meyer Assessment Modified Ashworth Scale Range of motion	—

Secondary

Measure	Time frame
Motor Activity Log Activity of daily living Quality of life	—

Countries

Japan

Contacts

Public ContactNori Sato

Tokushima University Hospital Department of Rehabilitation

norih@tokushima-u.ac.jp088-633-9313

Outcome results

None listed

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