Clinical trial NCT03546959: Dynamic Lycra Orthosis as an Adjunct to Botulinum Toxin-A Injection for Post-stroke Spasticity
Official title: Dynamic Lycra Orthosis as an Adjunct to Botulinum Toxin-A Injection of the Upper Limb in Adults Following Stroke: A Single-blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Spasticity as Sequela of Stroke
Upper Limb Hypertonia
Keywords: stroke
spasticity
lycra
orthosis
splint
treatment
upper extremity
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2018-06-06
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Paralel group randomized controlled study
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Fugl-Meyer Upper Extremity Motor Assessment Scale
timeFrame: Day 0
measure: Fugl-Meyer Upper Extremity Motor Assessment Scale
timeFrame: 3 weeks
measure: Fugl-Meyer Upper Extremity Motor Assessment Scale
timeFrame: 3 months
Secondary outcomes:
measure: Motricity Index Upper Limb
timeFrame: Day 0
measure: Motricity Index Upper Limb
timeFrame: 3 weeks
measure: Motricity Index Upper Limb
timeFrame: 3 months
measure: Box and Block Test (BBT)
timeFrame: Day 0
measure: Box and Block Test (BBT)
timeFrame: 3 weeks
measure: Box and Block Test (BBT)
timeFrame: 3 months
measure: Semmes-Weinstein monofilaments for sensory functions digit 1
timeFrame: Day 0
measure: Semmes-Weinstein monofilaments for sensory functions digit 2
timeFrame: Day 0
measure: Semmes-Weinstein monofilaments for sensory functions digit 4
timeFrame: Day 0
measure: Semmes-Weinstein monofilaments for sensory functions digit 5
timeFrame: Day 0
measure: Semmes-Weinstein monofilaments for sensory functions digit 1
timeFrame: 3 weeks
measure: Semmes-Weinstein monofilaments for sensory functions digit 2
timeFrame: 3 weeks
measure: Semmes-Weinstein monofilaments for sensory functions digit 4
timeFrame: 3 weeks
measure: Semmes-Weinstein monofilaments for sensory functions digit 5
timeFrame: 3 weeks
measure: Semmes-Weinstein monofilaments for sensory functions digit 1
timeFrame: 3 months
measure: Semmes-Weinstein monofilaments for sensory functions digit 2
timeFrame: 3 months
measure: Semmes-Weinstein monofilaments for sensory functions digit 4
timeFrame: 3 months
measure: Semmes-Weinstein monofilaments for sensory functions digit 5
timeFrame: 3 months
measure: Modified Ashworth Scale (MAS) of elbow flexor
timeFrame: Day 0
measure: Modified Ashworth Scale (MAS) of wrist flexor
timeFrame: Day 0
measure: Modified Ashworth Scale (MAS) of elbow flexor
timeFrame: 3 weeks
measure: Modified Ashworth Scale (MAS) of wrist flexor
timeFrame: 3 weeks
measure: Modified Ashworth Scale (MAS) of elbow flexor
timeFrame: 3 months
measure: Modified Ashworth Scale (MAS) of wrist flexor
timeFrame: 3 months
measure: Stroke Impact Scale Version 3.0 (SIS 3.0)
timeFrame: Day 0
measure: Stroke Impact Scale Version 3.0 (SIS 3.0)
timeFrame: 3 weeks
measure: Stroke Impact Scale Version 3.0 (SIS 3.0)
timeFrame: 3 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Esra Giray
Study officials:
affiliation: Marmara University
name: Hakan Gunduz, Prof
role: STUDY_CHAIR
References:
citation: Gracies JM, Marosszeky JE, Renton R, Sandanam J, Gandevia SC, Burke D. Short-term effects of dynamic lycra splints on upper limb in hemiplegic patients. Arch Phys Med Rehabil. 2000 Dec;81(12):1547-55. doi: 10.1053/apmr.2000.16346.
citation: Elliott C, Reid S, Hamer P, Alderson J, Elliott B. Lycra((R)) arm splints improve movement fluency in children with cerebral palsy. Gait Posture. 2011 Feb;33(2):214-9. doi: 10.1016/j.gaitpost.2010.11.008. Epub 2010 Dec 4.
citation: Elliott CM, Reid SL, Alderson JA, Elliott BC. Lycra arm splints in conjunction with goal-directed training can improve movement in children with cerebral palsy. NeuroRehabilitation. 2011;28(1):47-54. doi: 10.3233/NRE-2011-0631.
citation: Nicholson JH, Morton RE, Attfield S, Rennie D. Assessment of upper-limb function and movement in children with cerebral palsy wearing lycra garments. Dev Med Child Neurol. 2001 Jun;43(6):384-91. doi: 10.1017/s001216220100072x.
citation: Gracies JM, Fitzpatrick R, Wilson L, Burke D, Gandevia SC. Lycra garments designed for patients with upper limb spasticity: mechanical effects in normal subjects. Arch Phys Med Rehabil. 1997 Oct;78(10):1066-71. doi: 10.1016/s0003-9993(97)90129-5.
citation: Giray E, Gencer Atalay K, Eren N, Gunduz OH, Karadag-Saygi E. Effects of dynamic lycra orthosis as an adjunct to rehabilitation after botulinum toxin-A injection of the upper-limb in adults following stroke: A single-blinded randomized controlled pilot study. Top Stroke Rehabil. 2020 Sep;27(6):473-481. doi: 10.1080/10749357.2019.1704371. Epub 2019 Dec 23.