Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06358976
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-15
First Post:
2024-04-06
Brief Title:
Anti-Spastic Splint With Focal Muscle Vibration for Stroke Hand Spasticity
Sponsor:
Arab American University Palestine
Organization:
Arab American University Palestine
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None