NCT03549975

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4 stroke

Timeline
Completed

Started May 2016

Shorter than P25 for phase_4 stroke

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 18, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 8, 2018

Completed
Last Updated

June 8, 2018

Status Verified

May 1, 2018

Enrollment Period

1.3 years

First QC Date

May 16, 2018

Last Update Submit

May 25, 2018

Conditions

StrokeSpastic HemiparesisSpasticity as Sequela of Stroke

Keywords

strokehandbotulinum toxinfunctional electrical stimulation

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (10)

  • Muscle strength of finger extensor

    baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline

  • Spasticity of finger extensor

    baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline

  • active range of motion of wrist joint

    baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline

  • Brunnstrom stage of stroke recovery of distal upper extremity

    baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline

  • Distance from middle finger tip to mid-palmar crease

    baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline

  • +5 more secondary outcomes

Study Arms (1)

Botulinum toxin type A injection

EXPERIMENTAL

Botulinum toxin type A injection followed by functional electrical stimulation

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

Interventions

Botulinum Toxin Type A 100 unit/Vial (Product)DRUG

Botulinum toxin type A injection followed by functional electrical stimulation

Also known as: functional electrical stimulation
Botulinum toxin type A injection

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

StrokeHemiplegia

Interventions

Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Joon-Ho Shin, MS

    National Rehabilitation Center of Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Team manager of Department of Neurorehabilitation

Study Record Dates

First Submitted

May 16, 2018

First Posted

June 8, 2018

Study Start

May 18, 2016

Primary Completion

August 18, 2017

Study Completion

August 18, 2017

Last Updated

June 8, 2018

Record last verified: 2018-05