CompletedNot Applicable

Condensed and Distributed Robotic Therapy in Spastic Stroke Post Botulinum Toxin Injection

Taiwan36 participantsStarted 2017-10-01

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 between condensed and distributed robot-assisted training (RT) programs in patients with spastic hemiplegic stroke. Spasticity, a common impairment after stroke, has a profound impact on activity and participation for patients. According to the result of the investigator's ongoing study, the investigators found BoNT-A injection combined with robot-assisted training is recommended to enhance functional recovery for patients with spastic hemiplegic stroke. However, the optimal program as considering the RT frequency is unknown. The aims of this study are to determine and compare the immediate and longer-term effects between condensed and distributed programs of RT following BoNT-A injection in subjects with spastic hemiplegic stroke . Participants with chronic spastic hemiplegic stroke will be recruited and randomly assigned to either condensed or distributed RT groups post BoNT-A injection. Each training session included 40 minutes RT, followed by 40-minute functional training. The condensed group will receive 4 sessions per week, for 6 weeks, the distributed group 2 sessions per week, for 12 weeks. Body function and structures outcome measures include Fugl-Meyer Assessment, Modified Ashworth Scale. Activity and participation measures include Wolf Motor Function Test, Motor Activity Log, and Canadian Occupational Performance Measure. In addition, to directly reflect a patient's unique needs and goals, Goal Attainment Scaling will be assessed. Evaluators will be blind to group allocation. The outcome will be measured at pre-treatment, post-treatment, and 6-week follow-up. The investigators will also use the movement time of robot without powered assistance and surface EMG to determine the motor learning processes of patients receiving the two practice frequencies of RT. This comparative efficacy study will be the first to examine and compare the motor learning processes and immediate and long-term effects between condensed and distributed RT post BoNT injection. The results may provide clinicians with the appropriate methods to scheduling RT following BoNT-A injection to improve upper limb functions for patients with hemiplegic spasticity stroke.

Who can participate

Age range

18 Years

Sex

ALL

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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
. upper limb spasticity (modified Ashworth scale of ≥ 1+ for elbow flexor and/or forearm pronator and/or finger flexor muscles and/or wrist flexor muscles (Bohannon \& Smith, 1987)
. initial motor part of UE of FMA score ranging from 17 to 56, indicating moderate to severe movement impairment (Duncan, Goldstein, Matchar, Divine, \& Feussner, 1992; Fugl Meyer, Jaasko, \& Leyman, 1975; Park, Wolf, Blanton, Winstein, \& Nichols-Larsen, 2008)
. no serious cognitive impairment (i.e., Mini Mental State Exam score \> 20) (Teng \& Chui, 1987)
. age ≥ 18 years
. willing to provide written informed consent

Exclusion criteria

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?

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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: assessed at 1 week before intervention, 5 weeks after injection (in the middle of intervention), 1 week after intervention (post-intervention), 6 weeks after intervention., change from baseline at 1.5 months reported

Wolf Motor Function Test (WMFT)-Time

Modified Ashworth Scale (Masiero et al.)

Wolf Motor Function Test (WMFT)-Function

Trial details

NCT IDNCT03321097

SponsorChang Gung Memorial Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-05-07

Results submitted2019-06-27

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