CompletedNot Applicable

Exercise to Improve Sleep and Quality of Life in Stroke Patients Receiving Botulinum Toxin Treatment

Turkey (Türkiye)56 participantsStarted 2021-09-15

Plain-language summary

This study aimed to investigate the contribution of aerobic exercise programmes to improving sleep quality, quality of life, and functional status, alongside conventional rehabilitation, in stroke patients who had received botulinum toxin treatment for upper extremity spasticity.

Who can participate

Age range

18 Weeks – 75 Weeks

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: * 62 patients aged 18-75 years who were planned for botulinum toxin treatment due to upper extremity spasticity following a stroke Exclusion Criteria: * Stroke patients who had BTX-A injections for lower extremity spasticity or had a Modified Ashworth Scale (MASH) score ≥ 2 for lower extremity spasticity, * Uncontrolled diabetes, hypertension, cardiovascular diseases, * Cognitive dysfunction, * Flaccid stroke, * Upper extremity disorders (fractures, frozen shoulder, arthritis, surgery), * Pre-existing sleep disorders (obstructive sleep apnea, insomnia, parasomnia, narcolepsy, restless leg syndrome, or psychiatric disorders), * Cancer diagnosis, * Those who had received antispastic or antiepileptic treatment with dose changes in the last month

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

Functional Recovery, Sleep, and Quality of Life Outcomes

Timeframe: From baseline to 12 weeks after starting the exercise program

Effects of Aerobic Exercise on Sleep Quality, Quality of Life, and Functional Status in Stroke Patients Treated with BTX-A for Upper Extremity Spasticity

Timeframe: From baseline to 12 weeks after starting the exercise program

Trial details

NCT IDNCT07369453

SponsorBursa Yuksek Ihtisas Training and Research Hospital

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2024-01-15

View on ClinicalTrials.gov More Hemiplegia and/or Hemiparesis Following Stroke trials

Who can participate

Age range

18 Weeks – 75 Weeks

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

Functional Recovery, Sleep, and Quality of Life Outcomes

Timeframe: From baseline to 12 weeks after starting the exercise program

Effects of Aerobic Exercise on Sleep Quality, Quality of Life, and Functional Status in Stroke Patients Treated with BTX-A for Upper Extremity Spasticity

Timeframe: From baseline to 12 weeks after starting the exercise program