StrokeNCT03546959
Dynamic Lycra Orthosis as an Adjunct to Botulinum Toxin-A Injection for Post-stroke Spasticity
A study testing Lycra sleeve, Rehabilitation and Botulinum Toxin in people with Stroke and Spasticity as Sequela of Stroke, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Stroke, Spasticity as Sequela of Stroke, Upper Limb Hypertonia
- What is being tested?
- Lycra sleeve, Rehabilitation and Botulinum Toxin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jun 2018to 11 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult stroke (18-80 years)
- Patients with stroke who can sit without support
- Patients with stroke who have spasticity which limit upper limb function
Who cannot join
- Brunnstrom motor recovery stage 1 and 6
- Comorbidities such as hemiplegic shoulder pain, complex regional pain syndrome, central post-stroke pain, brachial plexus injury etc.
- Upper limb spasticity with MAS level 4 or presence of contracture in upper extremity.
- Contraindications for lycra sleeve ( circulatory disorder etc.)
- Contraindications for botulinum toxin (infection at the injection site, hypersensitivity to toxin etc.)
- Severe aphasia or cognitive dysfunction that limit participation in rehabilitation (7) Receiving botulinum toxin injection within the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Lycra sleeve, Rehabilitation, Botulinum Toxin
- Keywords
- stroke, spasticity, lycra, orthosis, splint, treatment, upper extremity
- Medical subject headings
- Stroke, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lycra sleeveOther
Also called Rehabilitation after botulinum toxin injection
custom-fitted lycra sleeve extending from axilla to wrist
RehabilitationOther
Also called botulinum toxin injection for post stroke spasticity
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 ToxinDrug
Also called botulinum toxin injection for post stroke spasticity
Botulinum toxin injection for upper limb spasticity after stroke
| Study group | Role | What they receive |
|---|---|---|
| Lycra sleeve after botulinum toxin | Experimental | 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 Receives: Other: Lycra sleeve; Other: Rehabilitation; Drug: Botulinum Toxin |
| Rehabilitation after botulinum toxin | Active comparator | Rehabilitation (five days a week for three weeks) after botulinum toxin injection for post-stroke spasticity Receives: Other: Rehabilitation; Drug: Botulinum Toxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Upper Extremity Motor Assessment Scale
Fugl-Meyer Upper Extremity Assessment assesses motor impairment in the upper extremities. There is no total score for this measure. Sub-scales include: upper extremity (0-36), wrist (0-10), hand (0-14), coordination/speed (0-6) (which can be combined to form a total motor function score out of 66). Higher scores indicate better performance.
Measured: Day 0
Fugl-Meyer Upper Extremity Motor Assessment Scale
Fugl-Meyer Upper Extremity Assessment assesses motor impairment in the upper extremities. There is no total score for this measure. Sub-scales include: upper extremity (0-36), wrist (0-10), hand (0-14), coordination/speed (0-6) (which can be combined to form a total motor function score out of 66). Higher scores indicate better performance.
Measured: 3 weeks
Fugl-Meyer Upper Extremity Motor Assessment Scale
Fugl-Meyer Upper Extremity Assessment assesses motor impairment in the upper extremities. There is no total score for this measure. Sub-scales include: upper extremity (0-36), wrist (0-10), hand (0-14), coordination/speed (0-6) (which can be combined to form a total motor function score out of 66). Higher scores indicate better performance.
Measured: 3 months
Secondary outcomes (27)
Motricity Index Upper Limb
Upper limb motor function Resistance to pinch, elbow flexion and shoulder abduction are scored to a maximum score of 33. Section scores are summed to a total of 100.
0 = No movement.
9 = Palpable contraction in muscle but no movement.
14 = Movement seen but not full range/ not against gravity.
19 = Full range against gravity, not against resistance.
25 = Movement against resistance but weaker than other side.
33 = Normal power.
Measured: Day 0
Motricity Index Upper Limb
Upper limb motor function Resistance to pinch, elbow flexion and shoulder abduction are scored to a maximum score of 33. Section scores are summed to a total of 100.
0 = No movement.
9 = Palpable contraction in muscle but no movement.
14 = Movement seen but not full range/ not against gravity.
19 = Full range against gravity, not against resistance.
25 = Movement against resistance but weaker than other side.
33 = Normal power.
Measured: 3 weeks
Motricity Index Upper Limb
Upper limb motor function Resistance to pinch, elbow flexion and shoulder abduction are scored to a maximum score of 33. Section scores are summed to a total of 100.
0 = No movement.
9 = Palpable contraction in muscle but no movement.
14 = Movement seen but not full range/ not against gravity.
19 = Full range against gravity, not against resistance.
25 = Movement against resistance but weaker than other side.
33 = Normal power.
Measured: 3 months
Box and Block Test (BBT)
Evaluates gross manuel dexterity. Box and Block Test which consists of a box divided into two compartments by a partition and blocks with standardized dimensions is used to assess unilateral gross manuel dexterity. The object is instructed to transport boxes one by one from one compartment of the box to other in 60 seconds. The object should sit on a chair with a standard height and face the box. He/she should practice for a 15 second trial period before testing. If two blocks are carried at the same time, it is counted as one. And also if the block falls on the floor after it has been carried across, it is still counted. The score is the number of boxes transferred from one compartment to other in 60 seconds.
Measured: Day 0
Box and Block Test (BBT)
Evaluates gross manuel dexterity. Box and Block Test which consists of a box divided into two compartments by a partition and blocks with standardized dimensions is used to assess unilateral gross manuel dexterity. The object is instructed to transport boxes one by one from one compartment of the box to other in 60 seconds. The object should sit on a chair with a standard height and face the box. He/she should practice for a 15 second trial period before testing. If two blocks are carried at the same time, it is counted as one. And also if the block falls on the floor after it has been carried across, it is still counted. The score is the number of boxes transferred from one compartment to other in 60 seconds.
Measured: 3 weeks
Box and Block Test (BBT)
Evaluates gross manuel dexterity. Box and Block Test which consists of a box divided into two compartments by a partition and blocks with standardized dimensions is used to assess unilateral gross manuel dexterity. The object is instructed to transport boxes one by one from one compartment of the box to other in 60 seconds. The object should sit on a chair with a standard height and face the box. He/she should practice for a 15 second trial period before testing. If two blocks are carried at the same time, it is counted as one. And also if the block falls on the floor after it has been carried across, it is still counted. The score is the number of boxes transferred from one compartment to other in 60 seconds.
Measured: 3 months
Semmes-Weinstein monofilaments for sensory functions digit 1
Assess touch detection thresholds of the fingers. 5 filaments from 0.07 gram to 279 grams will be used. Five different positions of the hand are tested: fingertip on digit 1,2,4 and 5.
Measured: Day 0
Semmes-Weinstein monofilaments for sensory functions digit 2
Assess touch detection thresholds of the fingers. 5 filaments from 0.07 gram to 279 grams will be used. Five different positions of the hand are tested: fingertip on digit 1,2,4 and 5.
Measured: Day 0
Semmes-Weinstein monofilaments for sensory functions digit 4
Assess touch detection thresholds of the fingers. 5 filaments from 0.07 gram to 279 grams will be used. Five different positions of the hand are tested: fingertip on digit 1,2,4 and 5.
Measured: Day 0
Semmes-Weinstein monofilaments for sensory functions digit 5
Assess touch detection thresholds of the fingers. 5 filaments from 0.07 gram to 279 grams will be used. Five different positions of the hand are tested: fingertip on digit 1,2,4 and 5.
Measured: Day 0
Semmes-Weinstein monofilaments for sensory functions digit 1
Assess touch detection thresholds of the fingers. 5 filaments from 0.07 gram to 279 grams will be used. Five different positions of the hand are tested: fingertip on digit 1,2,4 and 5.
Measured: 3 weeks
Semmes-Weinstein monofilaments for sensory functions digit 2
Assess touch detection thresholds of the fingers. 5 filaments from 0.07 gram to 279 grams will be used. Five different positions of the hand are tested: fingertip on digit 1,2,4 and 5.
Measured: 3 weeks
Semmes-Weinstein monofilaments for sensory functions digit 4
Assess touch detection thresholds of the fingers. 5 filaments from 0.07 gram to 279 grams will be used. Five different positions of the hand are tested: fingertip on digit 1,2,4 and 5.
Measured: 3 weeks
Semmes-Weinstein monofilaments for sensory functions digit 5
Assess touch detection thresholds of the fingers. 5 filaments from 0.07 gram to 279 grams will be used. Five different positions of the hand are tested: fingertip on digit 1,2,4 and 5.
Measured: 3 weeks
Semmes-Weinstein monofilaments for sensory functions digit 1
Assess touch detection thresholds of the fingers. 5 filaments from 0.07 gram to 279 grams will be used. Five different positions of the hand are tested: fingertip on digit 1,2,4 and 5.
Measured: 3 months
Semmes-Weinstein monofilaments for sensory functions digit 2
Assess touch detection thresholds of the fingers. 5 filaments from 0.07 gram to 279 grams will be used. Five different positions of the hand are tested: fingertip on digit 1,2,4 and 5.
Measured: 3 months
Semmes-Weinstein monofilaments for sensory functions digit 4
Assess touch detection thresholds of the fingers. 5 filaments from 0.07 gram to 279 grams will be used. Five different positions of the hand are tested: fingertip on digit 1,2,4 and 5.
Measured: 3 months
Semmes-Weinstein monofilaments for sensory functions digit 5
Assess touch detection thresholds of the fingers. 5 filaments from 0.07 gram to 279 grams will be used. Five different positions of the hand are tested: fingertip on digit 1,2,4 and 5.
Measured: 3 months
Modified Ashworth Scale (MAS) of elbow flexor
elbow flexor muscle tone 0 (0) - No increase in muscle tone 1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension
1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of motion (ROM) 2 (3) - More marked increase in muscle tone through most of the ROM, but affect part(s) easily moved 3 (4) - Considerable increase in muscle tone passive, movement difficult 4 (5) - Affected part(s) rigid in flexion or extension
Measured: Day 0
Modified Ashworth Scale (MAS) of wrist flexor
wrist flexor muscle tone 0 (0) - No increase in muscle tone 1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension
1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM 2 (3) - More marked increase in muscle tone through most of the ROM, but affect part(s) easily moved 3 (4) - Considerable increase in muscle tone passive, movement difficult 4 (5) - Affected part(s) rigid in flexion or extension
Measured: Day 0
Modified Ashworth Scale (MAS) of elbow flexor
elbow flexor muscle tone 0 (0) - No increase in muscle tone 1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension
1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM 2 (3) - More marked increase in muscle tone through most of the ROM, but affect part(s) easily moved 3 (4) - Considerable increase in muscle tone passive, movement difficult 4 (5) - Affected part(s) rigid in flexion or extension
Measured: 3 weeks
Modified Ashworth Scale (MAS) of wrist flexor
wrist flexor muscle tone 0 (0) - No increase in muscle tone 1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension
1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM 2 (3) - More marked increase in muscle tone through most of the ROM, but affect part(s) easily moved 3 (4) - Considerable increase in muscle tone passive, movement difficult 4 (5) - Affected part(s) rigid in flexion or extension
Measured: 3 weeks
Modified Ashworth Scale (MAS) of elbow flexor
elbow flexor muscle tone 0 (0) - No increase in muscle tone 1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension
1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM 2 (3) - More marked increase in muscle tone through most of the ROM, but affect part(s) easily moved 3 (4) - Considerable increase in muscle tone passive, movement difficult 4 (5) - Affected part(s) rigid in flexion or extension
Measured: 3 months
Modified Ashworth Scale (MAS) of wrist flexor
wrist flexor muscle tone 0 (0) - No increase in muscle tone 1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension
1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM 2 (3) - More marked increase in muscle tone through most of the ROM, but affect part(s) easily moved 3 (4) - Considerable increase in muscle tone passive, movement difficult 4 (5) - Affected part(s) rigid in flexion or extension
Measured: 3 months
Stroke Impact Scale Version 3.0 (SIS 3.0)
The SIS 3.0 is a stroke-specific instrument of health-related quality of life. It contains 59 items measuring 8 domains (i.e., strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion. memory and thinking and participation) with a single item assessing perceived overall recovery from stroke. Items are rated on a 5-point Likert scale with lower scores indicating greater difficulty in task completion during the past week.
Measured: Day 0
Stroke Impact Scale Version 3.0 (SIS 3.0)
The SIS 3.0 is a stroke-specific instrument of health-related quality of life. It contains 59 items measuring 8 domains (i.e., strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion. memory and thinking and participation) with a single item assessing perceived overall recovery from stroke. Items are rated on a 5-point Likert scale with lower scores indicating greater difficulty in task completion during the past week.
Measured: 3 weeks
Stroke Impact Scale Version 3.0 (SIS 3.0)
The SIS 3.0 is a stroke-specific instrument of health-related quality of life. It contains 59 items measuring 8 domains (i.e., strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion. memory and thinking and participation) with a single item assessing perceived overall recovery from stroke. Items are rated on a 5-point Likert scale with lower scores indicating greater difficulty in task completion during the past week.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start6 Jun 2018
- Primary completion11 Feb 2019
- Study completion11 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Paralel group randomized controlled study
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hakan Gunduz, Prof, Study chair, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03546959
- Sponsor's protocol ID
- 09.2017.677
- Status last verified
- Jun 2018
- First submitted
- 12 May 2018
- Last updated
- 18 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 11128888Elliott 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.
PubMed 21131201Elliott 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.
PubMed 21335677Nicholson 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.
PubMed 11409827Gracies 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.
PubMed 9339154Giray 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.
PubMed 31868130
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03546959
- Acronym / sponsor ID
- 09.2017.677
- Keywords
- stroke, spasticity, lycra, orthosis, splint, treatment, upper extremity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 6 Jun 2018 (actual)
- Primary completion
- 11 Feb 2019 (actual)
- Study completion
- 11 Feb 2019 (actual)
- First posted
- 6 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Paralel group randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Lycra sleeve after botulinum toxin | Experimental | Other: Lycra sleeve, Other: Rehabilitation, Drug: Botulinum Toxin8 hours a day lycra sleeve wear plus rehabilitation (for five days a week for three weeks) after botulinum toxin injection for post-stroke spasticity |
| Rehabilitation after botulinum toxin | Active comparator | Other: Rehabilitation, Drug: Botulinum ToxinRehabilitation (five days a week for three weeks) after botulinum toxin injection for post-stroke spasticity |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult stroke (18-80 years)
- Patients with stroke who can sit without support
- Patients with stroke who have spasticity which limit upper limb function
Key exclusion criteria (6 listed)
- Brunnstrom motor recovery stage 1 and 6
- Comorbidities such as hemiplegic shoulder pain, complex regional pain syndrome, central post-stroke pain, brachial plexus injury etc.
- Upper limb spasticity with MAS level 4 or presence of contracture in upper extremity.
- Contraindications for lycra sleeve ( circulatory disorder etc.)
- Contraindications for botulinum toxin (infection at the injection site, hypersensitivity to toxin etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lycra sleeveAlso: Rehabilitation after botulinum toxin injectioncustom-fitted lycra sleeve extending from axilla to wrist | Other | Lycra sleeve after botulinum toxin |
| RehabilitationAlso: botulinum toxin injection for post stroke spasticityPassive, 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 | Other | Lycra sleeve after botulinum toxin, Rehabilitation after botulinum toxin |
| Botulinum ToxinAlso: botulinum toxin injection for post stroke spasticityBotulinum toxin injection for upper limb spasticity after stroke | Drug | Lycra sleeve after botulinum toxin, Rehabilitation after botulinum toxin |
Primary outcome
Fugl-Meyer Upper Extremity Motor Assessment Scale
Time frame: Day 0
Fugl-Meyer Upper Extremity Assessment assesses motor impairment in the upper extremities. There is no total score for this measure. Sub-scales include: upper extremity (0-36), wrist (0-10), hand (0-14), coordination/speed (0-6) (which can be combined to form a total motor function score out of 66). Higher scores indicate better performance.
Fugl-Meyer Upper Extremity Motor Assessment Scale
Time frame: 3 weeks
Fugl-Meyer Upper Extremity Assessment assesses motor impairment in the upper extremities. There is no total score for this measure. Sub-scales include: upper extremity (0-36), wrist (0-10), hand (0-14), coordination/speed (0-6) (which can be combined to form a total motor function score out of 66). Higher scores indicate better performance.
Fugl-Meyer Upper Extremity Motor Assessment Scale
Time frame: 3 months
Fugl-Meyer Upper Extremity Assessment assesses motor impairment in the upper extremities. There is no total score for this measure. Sub-scales include: upper extremity (0-36), wrist (0-10), hand (0-14), coordination/speed (0-6) (which can be combined to form a total motor function score out of 66). Higher scores indicate better performance.
27 secondary outcomes
Motricity Index Upper Limb
Time frame: Day 0
Motricity Index Upper Limb
Time frame: 3 weeks
Motricity Index Upper Limb
Time frame: 3 months
Box and Block Test (BBT)
Time frame: Day 0
Box and Block Test (BBT)
Time frame: 3 weeks
Box and Block Test (BBT)
Time frame: 3 months
Semmes-Weinstein monofilaments for sensory functions digit 1
Time frame: Day 0
Semmes-Weinstein monofilaments for sensory functions digit 2
Time frame: Day 0
Semmes-Weinstein monofilaments for sensory functions digit 4
Time frame: Day 0
Semmes-Weinstein monofilaments for sensory functions digit 5
Time frame: Day 0
Semmes-Weinstein monofilaments for sensory functions digit 1
Time frame: 3 weeks
Semmes-Weinstein monofilaments for sensory functions digit 2
Time frame: 3 weeks
Semmes-Weinstein monofilaments for sensory functions digit 4
Time frame: 3 weeks
Semmes-Weinstein monofilaments for sensory functions digit 5
Time frame: 3 weeks
Semmes-Weinstein monofilaments for sensory functions digit 1
Time frame: 3 months
Semmes-Weinstein monofilaments for sensory functions digit 2
Time frame: 3 months
Semmes-Weinstein monofilaments for sensory functions digit 4
Time frame: 3 months
Semmes-Weinstein monofilaments for sensory functions digit 5
Time frame: 3 months
Modified Ashworth Scale (MAS) of elbow flexor
Time frame: Day 0
Modified Ashworth Scale (MAS) of wrist flexor
Time frame: Day 0
Modified Ashworth Scale (MAS) of elbow flexor
Time frame: 3 weeks
Modified Ashworth Scale (MAS) of wrist flexor
Time frame: 3 weeks
Modified Ashworth Scale (MAS) of elbow flexor
Time frame: 3 months
Modified Ashworth Scale (MAS) of wrist flexor
Time frame: 3 months
Stroke Impact Scale Version 3.0 (SIS 3.0)
Time frame: Day 0
Stroke Impact Scale Version 3.0 (SIS 3.0)
Time frame: 3 weeks
Stroke Impact Scale Version 3.0 (SIS 3.0)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2019.
- Background: PubMed 11128888Gracies 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.
- Background: PubMed 21131201Elliott 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.
- Background: PubMed 21335677Elliott 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.
- Background: PubMed 11409827Nicholson 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.
- Background: PubMed 9339154Gracies 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.
- Derived from this study: PubMed 31868130Giray 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hakan Gunduz, Prof study chair
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lycra sleeve, Rehabilitation and Botulinum Toxin in people with Stroke and Spasticity as Sequela of Stroke, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Upper Extremity Motor Assessment Scale (time frame: Day 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03546959, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2019.