Clinical trial NCT06358976: Anti-Spastic Splint With Focal Muscle Vibration for Stroke Hand Spasticity
Official title: The Effectiveness of Anti-spastic Splint With Added Focal Muscle Vibration (FMV) in Decreasing Hand Spasticity and Improving Hand Functionality Among Individuals With Chronic Stroke: a Pilot Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Spasticity as Sequela of Stroke
Keywords: Stroke
Spasticity
Vibration
Splint
Upper limb
Lead sponsor: Arab American University (Palestine)
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 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.
Primary purpose: OTHER

Brief summary: Title: The Effect of Vibrating Splint on Hand Function After Stroke

Summary:

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.

Detailed description: This pilot randomized controlled trial (RCT) aims to assess the clinical effectiveness and efficacy of adding focal muscle vibration (FMV) to anti-spastic splint therapy for individuals with spasticity following a stroke. The study involves multiple centers in the Jenin area of Palestine, utilizing outpatient rehabilitation centers to recruit participants who have chronic spasticity post-stroke.

Study Objectives and Questions:

Determine whether adding FMV to anti-spastic splint therapy provides additional benefit for individuals with spasticity after a stroke.

Compare the outcomes of anti-spastic splint therapy, FMV therapy, and a combination of both interventions in individuals with post-stroke spasticity.

Explore participant perceptions regarding the effectiveness, acceptability, and adherence to the interventions.

Study Design and Procedures:

The study is a pilot, multi-center RCT with a single evaluator (evaluator-blind) approach to avoid bias.

Forty-eight participants will be randomly assigned to one of three groups: Arm 1 (anti-spastic splint and FMV), Arm 2 (FMV only), or Arm 3 (anti-spastic splint only).

Interventions will be delivered by trained rehabilitation specialists, including occupational and physical therapists.

Standardized intervention protocols will guide the delivery of FMV and anti-spastic splint therapy for a period of four weeks.

Participant Recruitment:

Participants with chronic post-stroke spasticity are recruited from multiple rehabilitation centers and screened based on specific inclusion and exclusion criteria.

Convenience sampling is used to enroll participants from available populations in the participating centers.

Data Collection and Management:

Baseline and post-treatment evaluations include measurements of spasticity, hand functionality, range of motion, and pain level.

Qualitative interviews will explore participants' experiences with the interventions and their perceptions of the treatments' effectiveness.

Data will be securely stored and anonymized to protect participants' privacy.

Statistical Analysis Plan:

Linear Mixed-Effects Models (LMEM) will be used to assess treatment effects, adjusting for correlation over time within participants.

The safety analysis will involve documenting and summarizing adverse events (AEs) across treatment groups.

The study aims to provide preliminary data on treatment effects and inform the design of future larger RCTs.

Eligibility criteria: Inclusion Criteria:

* Individuals affected by chronic (more than one year) spastic ischemic or hemorrhagic stroke
* Aged above 18 years old
* Medically stable (has no cardiovascular event in the last 12 months)
* A score of 1-4 on modified Ashworth scale.

Exclusion Criteria:

* Cardiovascular event in the past 12 months
* Received anti-spastic injections drugs into the affected hand in the last 6 months
* A score of less than 21 on Rowland Universal Dementia Assessment Scale (RUDAS)
* Upper limb and trunk musculoskeletal injuries
* A score of 0 on modified Ashworth scale.

Primary outcomes:
measure: Modified Ashworth Scale (MAS)
timeFrame: At day one, and the end of the intervention (after 4 weeks).
measure: Fugl-Meyer Assessment of Upper Extremity (FMA-UE)
timeFrame: At day one, and the end of the intervention (after 4 weeks).
measure: Range of Motion Assessment
timeFrame: At day one, and the end of the intervention (after 4 weeks).
measure: Numeric pain rating scale (NRS)
timeFrame: At day one, and the end of the intervention (after 4 weeks).
Secondary outcomes:
Other outcomes:
Locations:
city: Jenin
country: Palestinian Territory, occupied
facility: Arab American University
Study officials:
affiliation: Assistant professor
name: Hisham Arab Alkabeya, PhD
role: STUDY_CHAIR
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