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

NCT03546959 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-06-18

No results posted yet for this study

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

Interventions

OTHER

Lycra sleeve

custom-fitted lycra sleeve extending from axilla to wrist

OTHER

Rehabilitation

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

DRUG

Botulinum Toxin

Botulinum toxin injection for upper limb spasticity after stroke

Sponsors & Collaborators

  • Marmara University

    lead OTHER

Principal Investigators

  • Hakan Gunduz, Prof · Marmara University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-06
Primary Completion
2019-02-11
Completion
2019-02-11

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03546959 on ClinicalTrials.gov