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

Stroke Clinical Trial

Official title:

Hand Rehabilitation Using Botulinum Toxin and Functional Electrical Stimulation Among Stroke Patients With Limitation of Finger Extension Due to Spasticity- Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03549975
• Other study ID #: NRC-2016-02-011
• Status: Completed
• Phase: Phase 4
• Start date: May 18, 2016
• Est. completion date: August 18, 2017

Study information

• Verified date: May 2018
• Source: National Rehabilitation Center, Seoul, Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 18, 2017
• Est. primary completion date: August 18, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Muscle Spasticity
• Paresis
• Spastic Hemiparesis
• Spasticity as Sequela of Stroke
• Stroke

Intervention

Drug:
• Botulinum Toxin Type A 100 unit/Vial (Product)
Botulinum toxin type A injection followed by functional electrical stimulation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Rehabilitation Center, Seoul, Korea

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Box and Block test	number of box moved by affected upper extremity	baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
Primary	Change of Action Research Arm Test	Score of Action Research Arm Test	baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
Secondary	Muscle strength of finger extensor	Medical research council grading of muscle strength	baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
Secondary	Spasticity of finger extensor	Modified ashworth scale of finger flexor	baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
Secondary	active range of motion of wrist joint	active range of motion of wrist joint	baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
Secondary	Brunnstrom stage of stroke recovery of distal upper extremity	Brunnstrom stage of stroke recovery of distal upper extremity. By observing the pattern of participants posture, the stage was scored. The stage ranges from 1 to 6. Higher is better.	baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
Secondary	Distance from middle finger tip to mid-palmar crease	Distance from middle finger tip to mid-palmar crease	baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
Secondary	Repeated number of finger extension and flexion	Repeated number of finger extension and flexion	baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
Secondary	Quick Disabilities of Arm, Shoulder & Hand	Quick Disabilities of Arm, Shoulder & Hand is questionnaire about patients' symptoms as well as ability to perform certain activities in the last week.; Total score is obtained by summing the each question, and ranges from 0 (no disability) to 100 (most severe disability).	baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
Secondary	Grading of active thumb opposition	Grading of active thumb opposition. It is measured by observing the pattern of thumb opposition.	baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
Secondary	Grip strength	measured by Jamar dynamometer	baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
Secondary	Active finger extension	Active finger extension. It is graded by observation of voluntary finger extension.	baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline