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

NCT03546959 | Completed

• 1 other identifier: 09.2017.677
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Spasticity as Sequela of Stroke; Upper Limb Hypertonia

Keywords

stroke; spasticity; lycra; orthosis; splint; treatment; upper extremity

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  3 months

Secondary Outcomes (27)

• Motricity Index Upper Limb

  Day 0

• Motricity Index Upper Limb

  3 weeks

• Motricity Index Upper Limb

  3 months

• Box and Block Test (BBT)

  Day 0

• Box and Block Test (BBT)

  3 weeks

Study Arms (2)

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

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

Other: Rehabilitation; Drug: Botulinum Toxin

Interventions

Lycra sleeve OTHER

custom-fitted lycra sleeve extending from axilla to wrist

Also known as: Rehabilitation after botulinum toxin injection

Lycra sleeve after botulinum toxin

Rehabilitation 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

Also known as: botulinum toxin injection for post stroke spasticity

Lycra sleeve after botulinum toxin; Rehabilitation after botulinum toxin

Botulinum Toxin DRUG

Botulinum toxin injection for upper limb spasticity after stroke

Also known as: botulinum toxin injection for post stroke spasticity

Lycra sleeve after botulinum toxin; Rehabilitation after botulinum toxin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Esra Giray

Istanbul, 34899, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 11128888 BACKGROUND

• 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.

  PMID: 21131201 BACKGROUND

• 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.

  PMID: 21335677 BACKGROUND

• 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.

  PMID: 11409827 BACKGROUND

• 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.

  PMID: 9339154 BACKGROUND

• 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.

  PMID: 31868130 DERIVED

MeSH Terms

Conditions

Stroke; Muscle Spasticity

Interventions

Rehabilitation; Botulinum Toxins

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)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Hakan Gunduz, Prof

  Marmara University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: outcome assessor blinded to participants' allocated group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Paralel group randomized controlled study

Study Record Dates

• First Submitted: May 12, 2018
• First Posted: June 6, 2018
• Study Start: June 6, 2018
• Primary Completion: February 11, 2019
• Study Completion: February 11, 2019
• Last Updated: June 18, 2019

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)