protocolSection identificationModule nctId: NCT06358976, orgStudyIdInfo id: Spasticity splint and FMV, briefTitle: Anti-Spastic Splint With Focal Muscle Vibration for Stroke Hand Spasticity, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-01, primaryCompletionDateStruct date: 2024-11-30, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Arab American University (Palestine), class: OTHER, descriptionModule briefSummary: Title: The Effect of Vibrating Splint on Hand Function After StrokeSummary:This study aims to investigate the effectiveness of a vibrating splint in improving hand function and reducing spasticity among individuals who have experienced a stroke. Stroke is a major global health issue, often resulting in long-term disability and impairments in the upper limbs. Spasticity, a common complication of stroke, causes stiffness and involuntary muscle contractions, leading to difficulties in performing daily activities.Current treatment options for spasticity include medications and physical therapy techniques. However, these approaches may have limitations in terms of effectiveness and duration of benefits. Therefore, non-pharmacological interventions are being explored to enhance rehabilitation outcomes.The hypothesis of this study is that the use of a vibrating splint, which applies mechanical vibrations to the hand muscles, will decrease spasticity and improve hand functionality in individuals with chronic stroke. The vibrations from the splint stimulate the sensory receptors in the skin and muscles, leading to muscle relaxation and improved motor control.The study will be conducted as a pilot randomized controlled trial, involving participants who meet specific eligibility criteria. The participants will be divided into three arms, with each arm receiving a different intervention. Outcome measures, including assessments of spasticity, range of motion, pain levels, and functional abilities, will be collected before and after the intervention period.The findings from this study will contribute to the understanding of non-pharmacological approaches in managing spasticity and improving hand function after stroke. If the vibrating splint proves to be effective, it could offer a safe and accessible option for stroke survivors to enhance their recovery and regain independence in daily activities.This research is essential as it addresses the need for more effective interventions for spasticity management and hand rehabilitation after stroke. By providing valuable insights into the potential benefits of the vibrating splint, this study has the potential to improve the quality of life for individuals who have experienced a stroke and empower them to regain control over their hand movements., conditionsModule conditions: Spasticity as Sequela of Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, interventionModelDescription: The interventional study model for this clinical study is a pilot randomized controlled trial. Participants will be randomly assigned to one of three arms: Group A (vibrating splint intervention), Group B (standard splint intervention), or Group C (control group receiving no splint intervention). This model allows for the comparison of different interventions and the evaluation of their effectiveness in improving hand function and reducing spasticity after stroke. Randomization helps ensure that each group is comparable in terms of baseline characteristics, minimizing bias and increasing the validity of the study results., primaryPurpose: OTHER, maskingInfo masking: SINGLE, maskingDescription: In this clinical trial, due to the nature of the interventions, it may not be possible to mask or blind the participants or therapists to the treatment received. However, efforts will be made to blind the outcome assessors who will be responsible for evaluating the participants' hand function, spasticity, and other outcome measures. Blinding the outcome assessors helps minimize potential bias and ensures the objective assessment of the intervention's effectiveness. By keeping the assessors unaware of the participants' group allocations, the integrity and reliability of the study findings can be enhanced., whoMasked: INVESTIGATOR, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: Vibration plus anti-spastic hand splint, interventions name: Anti-spastic hand splint, interventions name: Vibration, outcomesModule primaryOutcomes measure: Modified Ashworth Scale (MAS), primaryOutcomes measure: Fugl-Meyer Assessment of Upper Extremity (FMA-UE), primaryOutcomes measure: Range of Motion Assessment, primaryOutcomes measure: Numeric pain rating scale (NRS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Arab American University, city: Jenin, zip: 240, country: Palestinian Territory, occupied, contacts name: Hisham Arab Alkabeya, PhD, role: CONTACT, phone: 0595637776, email: hisham.arabkkabeya@aaup.edu, geoPoint lat: 32.45943, lon: 35.30086, hasResults: False