StrokePhase 4NCT03549975
Hand Rehabilitation Using Botulinum Toxin and Functional Electrical Stimulation-pilot Study
A Phase 4 study testing Botulinum Toxin Type A 100 unit/Vial (Product) in people with Stroke and Spastic Hemiparesis, run by National Rehabilitation Center, Seoul, Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Stroke, Spastic Hemiparesis, Spasticity as Sequela of Stroke
- What is being tested?
- Botulinum Toxin Type A 100 unit/Vial (Product)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 18 May 2016to 18 Aug 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Hand Rehabilitation Using Botulinum Toxin and Functional Electrical Stimulation Among Stroke Patients With Limitation of Finger Extension Due to Spasticity- Pilot Study
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.
- Conditions
- Stroke, Spastic Hemiparesis, Spasticity as Sequela of Stroke
- Being tested
- Botulinum Toxin Type A 100 unit/Vial (Product)
- Keywords
- stroke, hand, botulinum toxin, functional electrical stimulation
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin Type A 100 unit/Vial (Product)Drug
Also called functional electrical stimulation
Botulinum toxin type A injection followed by functional electrical stimulation
| Study group | Role | What they receive |
|---|---|---|
| Botulinum toxin type A injection | Experimental | Botulinum toxin type A injection followed by functional electrical stimulation Receives: Drug: Botulinum Toxin Type A 100 unit/Vial (Product) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Box and Block test
number of box moved by affected upper extremity
Measured: 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
Measured: baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
Secondary outcomes (10)
Muscle strength of finger extensor
Medical research council grading of muscle strength
Measured: baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
Spasticity of finger extensor
Modified ashworth scale of finger flexor
Measured: baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
active range of motion of wrist joint
active range of motion of wrist joint
Measured: baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
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.
Measured: baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
Distance from middle finger tip to mid-palmar crease
Distance from middle finger tip to mid-palmar crease
Measured: baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
Repeated number of finger extension and flexion
Repeated number of finger extension and flexion
Measured: baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
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).
Measured: baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
Grading of active thumb opposition
Grading of active thumb opposition. It is measured by observing the pattern of thumb opposition.
Measured: baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
Grip strength
measured by Jamar dynamometer
Measured: baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
Active finger extension
Active finger extension. It is graded by observation of voluntary finger extension.
Measured: baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start18 May 2016
- Primary completion18 Aug 2017
- Study completion18 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Rehabilitation Center, Seoul, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Joon-Ho Shin, National Rehabilitation Center, Seoul, Korea
- Investigators
- Joon-Ho Shin, MS, Principal investigator, National Rehabilitation Center of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03549975
- Sponsor's protocol ID
- NRC-2016-02-011
- Status last verified
- May 2018
- First submitted
- 16 May 2018
- Last updated
- 8 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hand Rehabilitation Using Botulinum Toxin and Functional Electrical Stimulation Among Stroke Patients With Limitation of Finger Extension Due to Spasticity- Pilot Study
- ClinicalTrials.gov ID
- NCT03549975
- Acronym / sponsor ID
- NRC-2016-02-011
- Conditions
- Stroke, Spastic Hemiparesis, Spasticity as Sequela of Stroke
- Keywords
- stroke, hand, botulinum toxin, functional electrical stimulation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- National Rehabilitation Center, Seoul, KoreaOther government
- Study start
- 18 May 2016 (actual)
- Primary completion
- 18 Aug 2017 (actual)
- Study completion
- 18 Aug 2017 (actual)
- First posted
- 8 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Botulinum toxin type A injection | Experimental | Drug: Botulinum Toxin Type A 100 unit/Vial (Product)Botulinum toxin type A injection followed by functional electrical stimulation |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum Toxin Type A 100 unit/Vial (Product)Also: functional electrical stimulationBotulinum toxin type A injection followed by functional electrical stimulation | Drug | Botulinum toxin type A injection |
Primary outcome
Change in Box and Block test
Time frame: baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
number of box moved by affected upper extremity
Change of Action Research Arm Test
Time frame: baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
Score of Action Research Arm Test
10 secondary outcomes
Muscle strength of finger extensor
Time frame: baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
Spasticity of finger extensor
Time frame: baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
active range of motion of wrist joint
Time frame: baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
Brunnstrom stage of stroke recovery of distal upper extremity
Time frame: baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
Distance from middle finger tip to mid-palmar crease
Time frame: baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
Repeated number of finger extension and flexion
Time frame: baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
Quick Disabilities of Arm, Shoulder & Hand
Time frame: baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
Grading of active thumb opposition
Time frame: baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
Grip strength
Time frame: baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
Active finger extension
Time frame: baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joon-Ho Shin, MS principal investigator
National Rehabilitation Center of Korea
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Botulinum Toxin Type A 100 unit/Vial (Product) in people with Stroke and Spastic Hemiparesis, run by National Rehabilitation Center, Seoul, Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Box and Block test (time frame: baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2018.