Dynamic Lycra Orthosis as an Adjunct to Botulinum Toxin-A Injection for Post-stroke Spasticity
Condition: Stroke; Spasticity as Sequela of Stroke; Upper Limb Hypertonia
MeSH terms: Muscle Spasticity; Stroke
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Lycra sleeve; Rehabilitation; Botulinum Toxin
Intervention type(s): Other; Other; Drug
Intervention description(s): custom-fitted lycra sleeve extending from axilla to wrist; 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 injection for upper limb spasticity after stroke
Other intervention name(s): Rehabilitation after botulinum toxin injection; botulinum toxin injection for post stroke spasticity; botulinum toxin injection for post stroke spasticity
Intervention MeSH terms: Botulinum Toxins
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Paralel group randomized controlled study
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: stroke; spasticity; lycra; orthosis; splint; treatment; upper extremity