CompletedNot Applicable

Wearable Robotic System and Robotic Mirror Therapy in Spastic Hemiplegia Post Botulinum Toxin Injection

Taiwan31 participantsStarted 2019-08-01

Plain-language summary

The purpose of this project is to examine and compare the immediate and long-term effects of combined Botulinum toxin type A(BoNT-A) injection with wearable robotic hand system (RT) and Robotic mirror therapy (RMT) in patients with spastic hemiplegic stroke.

Who can participate

Age range

20 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: * Clinical and imagine diagnosis of a first or recurrent unilateral stroke ≥ 3 months * Finger flexor muscles spasticity (modified Ashworth scale of ≥ 1+) * Initial motor part of UE of FMA score ranging from 10 to 56 indicating moderate to severe movement impairment * No serious cognitive impairment (i.e., Mini Mental State Exam score \> 20) * Age ≥ 20 years Exclusion Criteria: * Pregnant * With bilateral hemispheric or cerebellar lesions * Sever aphasia * Significant visual field deficits or hemineglect * Contraindication for BoNT-A injection * Treatment with BoNT-A within 6 months before recruitment * Any fixed joint contracture of the affected upper limb * A history of orthopedic or other neurological diseases and/or medical conditions that would prevent adherence to the rehabilitation protocol

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

Fugl-Meyer Assessment (FMA)

Timeframe: Change from baseline at 5 months

Medical Research Council Scale (MRC)

Timeframe: Change from baseline at 5 months

Modified Ashworth Scale (MAS)

Timeframe: Change from baseline at 5 months

Box and Block Test (BBT)

Timeframe: Change from baseline at 5 months

Motor Activity Log (MAL) - Amount of Use Scale (AOU)

Timeframe: Change from baseline at 5 months

Motor Activity Log (MAL) - Quality of Movement Scale (QOM)

Timeframe: Change from baseline at 5 months

Trial details

NCT IDNCT04826900

SponsorChang Gung Memorial Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-01-23

Results submitted2022-03-22

View on ClinicalTrials.gov More Hemiplegia, Spastic trials

Who can participate

Age range

20 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.

What they're measuring

Fugl-Meyer Assessment (FMA)

Timeframe: Change from baseline at 5 months

Medical Research Council Scale (MRC)

Timeframe: Change from baseline at 5 months

Modified Ashworth Scale (MAS)

Timeframe: Change from baseline at 5 months

Box and Block Test (BBT)

Timeframe: Change from baseline at 5 months

Motor Activity Log (MAL) - Amount of Use Scale (AOU)

Timeframe: Change from baseline at 5 months

Motor Activity Log (MAL) - Quality of Movement Scale (QOM)

Timeframe: Change from baseline at 5 months