CompletedPhase 4

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

20 participantsStarted 2016-05-18

Plain-language 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.

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Box and Block test

Timeframe: baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline

Change of Action Research Arm Test

Timeframe: baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline

Trial details

NCT IDNCT03549975

SponsorNational Rehabilitation Center, Seoul, Korea

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2017-08-18

View on ClinicalTrials.gov More Stroke trials

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.