Clinical and Ultrasonographic Comparison of the Effect of Hot and Cold Therapy on Spasticity

NCT04775511 | Unknown

• 1 other identifier: DokuzUS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spastic Hemiplegia

Keywords

spastisity; ultrasonography; hot pack; cold pack

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change of the ankle range of motion

  All patients will be evaluated for 3 times; before treatment, first day of the treatment and fifth day of the treatment.

• Change of the degree of spastisity

  All patients will be evaluated for 3 times; before treatment, first day of the treatment and fifth day of the treatment.

Study Arms (3)

Heat Therapy with heating pads

EXPERIMENTAL

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.

Other: Heat Therapy with heating pads

Cold Therapy with ice packs

EXPERIMENTAL

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.

Other: Cold Therapy with ice packs

Stretching Exercises

OTHER

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.

Other: Stretching Exercises

Interventions

Heat Therapy with heating pads OTHER

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.

Heat Therapy with heating pads

Cold Therapy with ice packs OTHER

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.

Cold Therapy with ice packs

Stretching Exercises OTHER

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.

Stretching Exercises

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being first stroke attack
• Grade ≥1 Spasticity in the medial gastrocnemius muscle according to modified ashwort scale
• At least 6 weeks have passed since the stroke

You may not qualify if:

• Antispasticidal drug use
• Botulinum toxin injection into the gastrocnemius muscle
• Having another nervous system or orthopedic disease that can affect measurements

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Dokuz Eylul University

Izmir, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Hemiplegia

Interventions

Diathermy; Cryotherapy; Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hyperthermia, Induced; Therapeutics; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Physical Therapy Modalities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Banu Dilek

CONTACT

+905052248340; banu.dilek@deu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof

Study Record Dates

• First Submitted: February 29, 2020
• First Posted: March 1, 2021
• Study Start: February 22, 2021
• Primary Completion: March 1, 2023
• Study Completion: April 1, 2023
• Last Updated: May 11, 2022

Record last verified: 2022-05

Locations

TU (1)