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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04775511
Other study ID # DokuzUS
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 22, 2021
Est. completion date April 1, 2023

Study information

Verified date May 2022
Source Dokuz Eylul University
Contact Banu Dilek
Phone +905052248340
Email banu.dilek@deu.edu.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Spasticity is a positive sign of upper motor neuron syndrome. The frequency of spasticity development in patients with stroke is 38%. Spasticity is one of the important factors that negatively affect the rehabilitation potential and functional recovery of the patient. In the treatment of spasticity, oral antispasticide drugs, phenol, ethyl alcohol, botulinum toxin, and chemical nerve and motor point blocks, physical therapy, and rehabilitation, surgical methods are used. In the physical therapy rehabilitation program of spasticity, stretching and strengthening exercises, cold application, warm application, ultrasound therapy, electrical stimulation, biofeedback, extracorporeal shock therapy are used. Stretching exercises are the cornerstone of spasticity treatment. In many clinical and experimental studies, a decrease in spasticity has been noted after stretching exercises. It has been stated that the application of cold or hot applications before stretching may increase the effectiveness of spasticity treatment. The study comparing the effectiveness of hot and cold treatment applied before stretching exercises clinically and ultrasonographically has not been found in the literature. The purpose of this study is the evaluation of clinical and ultrasonographic comparison of the effect of hot and cold treatment on spasticity before stretching exercises in patients with stroke. This study is unique because it is the first study that evaluates the effect of hot and cold applications on spasticity before the stretching.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Other:
Heat Therapy with heating pads
20 minutes of heating pads will be applied to the medial gastrocnemius muscle, followed by gastrocnemius muscle stretching for 20 minutes. While the patient is lying in a prone position the towel, which is located between the skin and heating pads, and heating pads will be placed on the gastrocnemius muscle.
Cold Therapy with ice packs
20 minutes of ice packs will be applied to the medial gastrocnemius muscle, followed by gastrocnemius muscle stretching for 20 minutes. While the patient is lying in a prone position the towel, which is located between the skin and ice packs, and ice packs will be placed on the gastrocnemius muscle.
Stretching Exercises
20 minutes of stretching exercises will be applied. In stretching exercises, stretching will be done for 30 seconds. The stretching exercises, which contain the maximal tension to the ankle, will be performed by the same physiotherapist while the patient is in the supine position, hip and knee extension.

Locations

Country Name City State
Turkey Dokuz Eylul University Izmir

Sponsors (1)

Lead Sponsor Collaborator
Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Medial gastrokinemius muscle via ultrasonographic measurement Change of the medial gastrocinemius pennat angle, medial muscle fascicule length, achilles tendon length All patients will be evaluated for 3 times; before treatment, first day of the treatment and fifth day of the treatment.
Secondary Change of the ankle range of motion Ankle dorsiflexion will be measured by goniometry in knee extension and flexion. All patients will be evaluated for 3 times; before treatment, first day of the treatment and fifth day of the treatment.
Secondary Change of the degree of spastisity Spastisity will be measured by Modified Aschwort Scale. (5 point numerical scale that graded spasticity from 0 to 4, with 0 being no resistance and 4 being a limb rigid in flexion or extension.) All patients will be evaluated for 3 times; before treatment, first day of the treatment and fifth day of the treatment.
See also
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Recruiting NCT06086314 - The Effects of Neurorehabilitation Approaches Involving Different Upper Extremity Reactive Trainings in Stroke Patients N/A
Completed NCT03860662 - The Effect of Oral Baclofen and Botulinum Toxin Treatments in Hemiplegic Spasticity on the Nociceptive Flexor Reflex Phase 4
Withdrawn NCT01329705 - Dynamic Splinting for Plantarflexion in Spastic Hemiplegia N/A
Completed NCT04528966 - Effects of WBV in Children With Hemiparetic CP N/A
Recruiting NCT05449951 - Effect of Dry Needling on Spasticity in Stroke Survivors. N/A
Not yet recruiting NCT05615987 - Comparison of Botulinum Toxin Injection Techniques in Spasticity Phase 4
Recruiting NCT03402854 - tDCS and Bimanual Therapy for Children With Hemiplegic Cerebral Palsy N/A