CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
Botulinum Toxin +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03546959
NCT03546959N/ACompleted

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

Marmara University·interventional·Posted Jun 6, 2018·Updated Jun 18, 2019

In Brief

A clinical study evaluating Lycra sleeve, Rehabilitation, and 1 other intervention for Stroke and 2 related conditions. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesTurkey (Türkiye)
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJun 6, 2018
Enrollment StartJun 6, 2018
Primary CompletionFeb 11, 2019
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 8.1 years ago

Interventions

Lycra sleeveother

custom-fitted lycra sleeve extending from axilla to wrist

Rehabilitationother

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

Botulinum toxin injection for upper limb spasticity after stroke