Anti-Spastic Splint With Focal Muscle Vibration for Stroke Hand Spasticity

NCT06358976 | Not Yet Recruiting

• 1 other identifier: Spasticity splint and FMV
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Spasticity as Sequela of Stroke

Keywords

Stroke; Spasticity; Vibration; Splint; Upper limb

Outcome Measures

Primary Outcomes (4)

• Modified Ashworth Scale (MAS)

  Spasticity level will be evaluated using the MAS scale. The MAS measures muscle resistance during passive stretching. The test will be applied for spastic joints of affected upper extremities. The score will be recorded as (0, 1, +1, 2, 3, 4), (0= normal tone, 4 = affected part rigid in flexion or extension). The reliability of the modified Ashworth scale is very good (kappa = .84 for interrater and .83 for intra-rater comparisons). Measurement repetition will be performed by the same assessor to avoid affecting reliability. The test will be conducted in the assessment quiet room, with no distractions. The participants will be supine in a treatment bed, and therapist will assess the affected upper limb spasticity once and record the result in the assessment form. The assessor will be a qualified trained occupational therapist who has worked in a clinical role treating stroke patients with hand spasticity and familiar with MAS.

  At day one, and the end of the intervention (after 4 weeks).

• Fugl-Meyer Assessment of Upper Extremity (FMA-UE)

  The FMA-UE looks at reflex activity, volitional movement within synergies, volitional movement mixing synergies, and volitional movement with little or no synergy. The outcome scale's 33 items are divided into four subscales: shoulder and elbow, wrist, hand, and coordination. On a three-point ordinal scale, each of these items is assessed. 2 points are granted if a movement is completely completed, 1 point is awarded if the movement is half completed, and 0 points are awarded if the movement cannot be completed.

  At day one, and the end of the intervention (after 4 weeks).

• Range of Motion Assessment

  The assessment of Range of Motion (ROM) for the affected upper limb in stroke patients will employ the use of a goniometer to precisely measure joint mobility across multiple planes of movement. This comprehensive evaluation entails examining the patient's ability to actively or passively articulate their affected elbow, wrist, and hand joints. The measurement of each movement will be made through the goniometer-based approach.

  At day one, and the end of the intervention (after 4 weeks).

• Numeric pain rating scale (NRS)

  Numeric pain scale (NRS) is an essential tool for the assessment of pain intensity. It is widely used by healthcare providers. It consists of a horizontal line where the left end is labeled "no pain" or "0," indicating the absence of pain, while the right end is labeled as "worst pain imaginable" or "10". The participants are required to mark on the line the point that shows the pain level they are experiencing. The distance from the origin of the line, which is the left end, to the participant's symbol mark is the one that is used to present a numerical value. a representation which shows pain intensity, where the higher the value the more pain there is. The NRS is taken into account as a valid and reliable scale and is usually employed in to analyze pain intensity in clinical practice and to conduct research.

  At day one, and the end of the intervention (after 4 weeks).

Study Arms (3)

Vibration plus anti-spastic hand splint Arm

EXPERIMENTAL

In this clinical trial, vibration stimulation will be applied to the spastic hand antagonistic muscles using a specific device consisting of a volar anti-spastic hand splint and the arm vibrator. The volar anti-spastic hand splint will be custom-made for each participant at the prosthetic and orthotic clinic, following a standardized protocol. The arm vibrator, designed to fit the arm, will deliver the required vibration parameters. The intervention protocol involves a 30-minute vibration session administered three times weekly for four weeks, accompanied by daily utilization of the custom-made splint for 30 minutes each day.

Other: Vibration plus anti-spastic hand splint

Anti-spastic hand splint Arm

ACTIVE COMPARATOR

In the anti-spastic hand splint arm , participants will be provided with an anti-spastic splint without vibration. Both vibration plus anti-spastic hand splint arm and anti-spastic hand splint arm will adhere to the same splint standard regime and recommendations, which outlines the specific positioning for the splint.

Other: Anti-spastic hand splint

Vibration Arm

ACTIVE COMPARATOR

In vibration arm , participants will be provided with arm vibrator held in place by appropriate padded harness. A Standardized study protocol will be used each time with no splint.

Other: Vibration

Interventions

Vibration plus anti-spastic hand splint OTHER

vibration stimulation will be applied to the spastic hand antagonistic muscles using a volar anti-spastic hand splint and the Myovolt Arm vibrator.

Vibration plus anti-spastic hand splint Arm

Anti-spastic hand splint OTHER

the use of anti-spastic hand splint alone.

Anti-spastic hand splint Arm

Vibration OTHER

The use of hand vibrator alone

Vibration Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arab American University (Palestine): lead

Study Sites (1)

Arab American University

Jenin, 240, Palestinian Territories

Location

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MeSH Terms

Conditions

Stroke; Muscle Spasticity

Interventions

Vibration

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mechanical Phenomena; Physical Phenomena

Study Officials

• Hisham Arab Alkabeya, PhD

  Assistant professor

  STUDY CHAIR

Central Study Contacts

Amer Jaroshy, MSc

CONTACT

0597103320; amer.jaroshy@aaup.edu

Hisham Arab Alkabeya, PhD

CONTACT

0595637776; hisham.arabkabeya@aaup.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 6, 2024
• First Posted: April 11, 2024
• Study Start: August 1, 2024
• Primary Completion: November 30, 2024
• Study Completion: December 30, 2024
• Last Updated: April 15, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)