Hand Rehabilitation Using Botulinum Toxin and Functional Electrical Stimulation-pilot Study

National Rehabilitation Center, Seoul, Korea

Status and phase: Completed; Phase 4

Conditions: Stroke; Spasticity as Sequela of Stroke; Spastic Hemiparesis

Treatments: Drug: Botulinum Toxin Type A 100 unit/Vial (Product)

Study type: Interventional

Funder types: Other

Identifiers

NCT03549975

NRC-2016-02-011

Details and patient eligibility

About

The investigator tried to find out possibility of functional improvement using botulinum toxin injection targeting finger flexor spasticity with functional electrical stimulation among chronic stroke patients who did not show any improvement in hand function.

Enrollment: 20 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age over 18 years
• hemiplegic upper limb spasticity secondary to a unilateral ischemic or hemorrhagic stroke
• fingers and wrist flexor spasticity graded at least 1+ on the Modified Ashworth Scale
• at least 6 months since stroke

Exclusion criteria

• fixed contracture
• previous treatment of the upper limb spasticity with neurolytic or surgical procedure
• treatment with botulinum toxin type A in the previous 4 months
• any active device implant
• any neurological disorder, other than stroke causing motor deficits or spasticity
• inability to attend to and/or to cooperate with all outcome measure-related task secondary to cognitive impairment or aphasia
• pregnancy, planned pregnancy, or lactation
• contraindication to botulinum toxin type A

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Botulinum toxin type A injection

Experimental group

Description:

Botulinum toxin type A injection followed by functional electrical stimulation

Treatment:

Drug: Botulinum Toxin Type A 100 unit/Vial (Product)