CompletedNot Applicable

Lower Extremity Pressure Splints in HP

Lebanon30 participantsStarted 2025-05-13

Plain-language summary

Hemiplegia (weakness or paralysis on one side of the body) often impacts the lower extremities, making it challenging for patients to walk or move their legs effectively. This study aims to explore the effects of pressure splints on the lower extremity movement and function in individuals who have experienced a stroke and suffer from hemiplegia. Pressure splints are specialized devices designed to support and enhance muscle function by applying gentle pressure to the affected limbs. Participants in this study will be randomly assigned to one of two groups: the Splint Group (SG) or the Control Group (CG). The duration of the intervention will be six weeks. During this period, all the participants will receive neurodevelopmental therapy. In the SG exercises will be done with the help of the lower extremity pressure splints while participants in the CG will join the exercises without any splint. This study is significant as it may lead to the development of new methods to enhance recovery for stroke patients and offer better rehabilitation options.

Who can participate

Age range

50 Years – 80 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: * Having hemiplegia because of stroke * Time since stroke: 1 month to 1 year * Ability to Participate (a score of \>24 on the Mini-Mental State Examination). * Being voluntary * Age between 40-80 Exclusion Criteria: Severe Cognitive Impairment Other Neurological Disorders Severe Comorbidities or Spasticity on Lower Extremity Contraindications to Exercise Recurrent Stroke

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

Lower Extremity Motor Function

Timeframe: Through study completion, an average of 8 months

Balance

Timeframe: Through study completion, an average of 8 months

Lower Extremity Strength

Timeframe: Through study completion, an average of 8 months

Mobility

Timeframe: Through study completion, an average of 8 months

Trial details

NCT IDNCT06965894

SponsorIstinye University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-01

View on ClinicalTrials.gov More Hemiplegia trials

Plain-language summary

Who can participate

Age range

50 Years – 80 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

Lower Extremity Motor Function

Timeframe: Through study completion, an average of 8 months

Balance

Timeframe: Through study completion, an average of 8 months

Lower Extremity Strength

Timeframe: Through study completion, an average of 8 months

Mobility

Timeframe: Through study completion, an average of 8 months