Dynamic Lycra Orthosis as an Adjunct to Botulinum Toxin-A Injection for Post-stroke Spasticity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-06

Study Completion Date

2019-02-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Upper extremity splints are one of the nonpharmacologic treatments used to treat hypertonicity after stroke. The purpose of splinting is to support, to position, to immobilize, to prevent contracture and deformities, to reduce spasticity and to enhance function. Dynamic lycra splints have been found to improve spasticity, posture, and fluency of upper extremity movements in computerized analysis systems due to the effects of neutral warmth, circumferential pressure and by creating a low intensity prolonged stretch on hypertonic muscles , all of which contribute to increased sensory awareness of the involved limb. These splints are frequently used in the field of neurological rehabilitation, but there is not enough scientific evidence about their efficacy. It was demonstrated that lycra sleeves have positive effects on upper extremity function of children with cerebral palsy. Lycra sleeves for upper extremity function after stroke is a relatively new field of research.

The aim of this study is to investigate effects of dynamic lycra orthosis as an adjunct to botulinum toxin-a injection of the upper limb in adults following stroke.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effect of Ultrasound-Guided Botulinum Toxin Injections on Pain, Functionality, Spasticity, and Range of Motion in Patients With Post-Stroke Upper Extremity Spasticity

NCT05887479

Cerebrovascular Disorders Spasticity, Muscle Botulinum Toxin

WITHDRAWN PHASE4

Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Arm After a Stroke

NCT01392300

Post-stroke Spasticity of the Upper Limb

COMPLETED PHASE3

Dry Needling and Botulinum Toxin in the Management of Poststroke Spasticity

NCT03747900

Spasticity, Muscle

COMPLETED NA

Randomised, Evaluation-blinded, Crossover, Controlled Study Assessing Dynamic Hand Splinting in Adults With Post-stroke Hemiplegia (Orthox)

NCT02888548

Upper Limb Spasticity

TERMINATED NA

Optimal Dose of Extracorporeal Shock Wave Therapy After Botulinum Toxin Type A Injection for Post-stroke Spasticity

NCT02358005

Post-Stroke Elbow Spasticity

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Spasticity is defined as a velocity-dependent increase in muscle tone resulting from hyper-excitability of the tonic stretch reflex in people with upper motor neurone (UMN) syndrome following damage to the brain or spinal cord. If left untreated, a vicious cycle occurs, in which unopposed contraction (spastic dystonia) in the affected muscle groups leads to an abnormal limb posture, resulting in soft tissue shortening and further biomechanical changes in the contracted muscles. This in turn prevents muscle lengthening and further stiffness. Botulinum toxin type A (BoNT-A) has been shown to provide a sustained reduction in post-stroke upper-limb spasticity when combined with rehabilitation. Although the trial-based evidence for enhanced benefit through a combination of BoNT-A and physical intervention is limited, the benefits of a combined approach are well-accepted in clinical practice. A successful treatment package, often incorporating physical and pharmacological treatments, can improve physical function and can also prevent secondary complications. A recent systematic review concluded that there is an urgent need for large-scale, rigorous clinical trials that investigate the relative efficacy of therapy types as independent or combined interventions with BoNT-A injection.

Dynamic lycra splints are proposed to modify hypertonicity due to the effects of neutral warmth, circumferential pressure and by creating a low intensity prolonged stretch on hypertonic muscles, all of which contribute to increased sensory awareness of the involved limb. Lycra arm splints comprise circumferential lycra segments that are orientated to produce a specific 'direction of pull'. Lycra1 arm splints specifically aim to influence hypertonicity, posture and patterns of movement. All of which are expected to result in improved movement performance, particularly fluency or smoothness of movement and to contribute to improved function. It was demonstrated that lycra sleeves have positive effects on upper extremity function of children with cerebral palsy. Lycra sleeves for upper extremity function after stroke is a relatively new field of research. The aim of this study is to investigate effects of dynamic lycra orthosis as an adjunct to botulinum toxin-a injection of the upper limb in adults following stroke.

Patients with stroke for more than three months and who are in need for botulinum toxin injection for post-stroke upper limb spasticity will be randomized to two groups: Lycra sleeve plus rehabilitation and only rehabilitation groups. After botulinum toxin injection, both groups will receive rehabilitation program including passive, active and active assistive range of motion and stretching exercises for shoulder, elbow, wrist, facilitation and inhibition techniques, neuromuscular electrical stimulation for wrist extensors, strengthening exercises for affected upper extremity, occupational therapy for two hours a day, five days a week for three weeks. Intervention group will wear lycra sleeve for eight hours a day, five days a week for three weeks. Effects of lycra sleeves as an adjunct to rehabilitation program after botulinum toxin injection will be assessed by using Fugl Meyer Upper Limb Motor score and Motricity index for motor function, Modified Ashworth scale for spasticity, Box and Block test score for hand dexterity, Semmes-Weinstein monofilaments for sensory functions. Outcome assessment will be undertaken by a blinded assessor at before treatment, after treatment (at 3 weeks) and after three months.

Friedman test will be used to establish within group changes over time in outcome variables. Wilcoxon's signed-rank test will be performed to show differences in the parameters between baseline and follow-up points. Between groups differences will be analyzed by using Mann-Whitney U test. Results will be considered significant when P \< 0.05.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke Spasticity as Sequela of Stroke Upper Limb Hypertonia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Paralel group randomized controlled study

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

outcome assessor blinded to participants' allocated group

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lycra sleeve after botulinum toxin

8 hours a day lycra sleeve wear plus rehabilitation (for five days a week for three weeks) after botulinum toxin injection for post-stroke spasticity

Group Type EXPERIMENTAL

Lycra sleeve

Intervention Type OTHER

custom-fitted lycra sleeve extending from axilla to wrist

Rehabilitation

Intervention Type OTHER

Passive, active and active assistive range of motion and stretching exercises for shoulder, elbow, wrist, facilitation and inhibition techniques, neuromuscular electrical stimulation for wrist extensors, strengthening exercises for affected upper extremity, occupational therapy

Botulinum Toxin

Intervention Type DRUG

Botulinum toxin injection for upper limb spasticity after stroke

Rehabilitation after botulinum toxin

Rehabilitation (five days a week for three weeks) after botulinum toxin injection for post-stroke spasticity

Group Type ACTIVE_COMPARATOR

Rehabilitation

Intervention Type OTHER

Passive, active and active assistive range of motion and stretching exercises for shoulder, elbow, wrist, facilitation and inhibition techniques, neuromuscular electrical stimulation for wrist extensors, strengthening exercises for affected upper extremity, occupational therapy

Botulinum Toxin

Intervention Type DRUG

Botulinum toxin injection for upper limb spasticity after stroke

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lycra sleeve

custom-fitted lycra sleeve extending from axilla to wrist

Intervention Type OTHER

Rehabilitation

Passive, active and active assistive range of motion and stretching exercises for shoulder, elbow, wrist, facilitation and inhibition techniques, neuromuscular electrical stimulation for wrist extensors, strengthening exercises for affected upper extremity, occupational therapy

Intervention Type OTHER

Botulinum Toxin

Botulinum toxin injection for upper limb spasticity after stroke

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Rehabilitation after botulinum toxin injection botulinum toxin injection for post stroke spasticity botulinum toxin injection for post stroke spasticity

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Adult stroke (18-80 years)
2. Patients with stroke who can sit without support
3. Patients with stroke who have spasticity which limit upper limb function

Exclusion Criteria

1. Brunnstrom motor recovery stage 1 and 6
2. Comorbidities such as hemiplegic shoulder pain, complex regional pain syndrome, central post-stroke pain, brachial plexus injury etc.
3. Upper limb spasticity with MAS level 4 or presence of contracture in upper extremity.
4. Contraindications for lycra sleeve ( circulatory disorder etc.)
5. Contraindications for botulinum toxin (infection at the injection site, hypersensitivity to toxin etc.)
6. Severe aphasia or cognitive dysfunction that limit participation in rehabilitation (7) Receiving botulinum toxin injection within the last 6 months

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No