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

Primary Purpose

Spastic Hemiplegia

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Heat Therapy with heating pads
Cold Therapy with ice packs
Stretching Exercises
Sponsored by
Dokuz Eylul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spastic Hemiplegia focused on measuring spastisity, ultrasonography, hot pack, cold pack

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • Dokuz Eylul UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Heat Therapy with heating pads

Cold Therapy with ice packs

Stretching Exercises

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Medial gastrokinemius muscle via ultrasonographic measurement
Change of the medial gastrocinemius pennat angle, medial muscle fascicule length, achilles tendon length

Secondary Outcome Measures

Change of the ankle range of motion
Ankle dorsiflexion will be measured by goniometry in knee extension and flexion.
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.)

Full Information

First Posted
February 29, 2020
Last Updated
May 9, 2022
Sponsor
Dokuz Eylul University
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1. Study Identification

Unique Protocol Identification Number
NCT04775511
Brief Title
Clinical and Ultrasonographic Comparison of the Effect of Hot and Cold Therapy on Spasticity
Official Title
Clinical and Ultrasonographic Comparison of the Effect of Hot and Cold Therapy on Spasticity
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2021 (Actual)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
April 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
The study is a randomized and controlled study. 30 patients will be included to study who apply to Dokuz Eylül University Faculty of Medicine, Department of Physical Medicine and Rehabilitation Clinic with the complaint of spasticity after stroke, aged between 18-75 years. These patients will be divided in three groups randomly (group1 n:10, group 2 n:10, group 3 n:10). First group: 20 minutes of hot pack application to the medial gastrocnemius muscle. Then the patient will do stretching exercises to the gastrocnemius muscle, which will be done for 20 minutes. In hot pack for hot application; While the patient is lying in a prone position, a warm package, a towel between the skin and the skin will be applied on the gastrocnemius muscle and applied for 20 minutes. Second group: 20 minutes to apply a cold pack to the medial gastrocnemius muscle, followed by stretching the patient for 20 minutes to the gastrocnemius muscle. The cold pack is available for cold application; While the patient is lying in a prone position, a cold pack will be placed on the gastrocnemius muscle, and a towel will be applied for 20 minutes. Third group: 20 minutes of stretching and stretching exercises will be applied. In stretching exercises, stretching will be done for 30 seconds. The stretching exercise will be performed by the same physiotherapist with maximal tension to the ankle in the supine position of the patient in the hip and knee extension. These applications will continue as 5 sessions. Evaluations will be made before treatment, immediately after the first session and at the end of the 5th session. All patients will be evaluated for 3 times, before and after treatment and 5 session after the treatment with ultrasonographic measurements, ankle range of motion and spasticity degree. Primary aim of this study is to evaluate the effect of hotpack and cold pack applicatios on Madial gastrokinemius ultrasonographic changes. For this purpose, medial muscle fascicule length, pennat angle and achilles tendon length with ultrasonographic measurement. Secondary aim is evaluating the effect of hot and cold pack on spastisity and ankle range of motion. Spastisity will be measured by Aschwort scale and range of motion will be measured by goniomertry.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spastic Hemiplegia
Keywords
spastisity, ultrasonography, hot pack, cold pack

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Heat Therapy with heating pads
Arm Type
Experimental
Arm Description
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.
Arm Title
Cold Therapy with ice packs
Arm Type
Experimental
Arm Description
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.
Arm Title
Stretching Exercises
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Heat Therapy with heating pads
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Cold Therapy with ice packs
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Stretching Exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Medial gastrokinemius muscle via ultrasonographic measurement
Description
Change of the medial gastrocinemius pennat angle, medial muscle fascicule length, achilles tendon length
Time Frame
All patients will be evaluated for 3 times; before treatment, first day of the treatment and fifth day of the treatment.
Secondary Outcome Measure Information:
Title
Change of the ankle range of motion
Description
Ankle dorsiflexion will be measured by goniometry in knee extension and flexion.
Time Frame
All patients will be evaluated for 3 times; before treatment, first day of the treatment and fifth day of the treatment.
Title
Change of the degree of spastisity
Description
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.)
Time Frame
All patients will be evaluated for 3 times; before treatment, first day of the treatment and fifth day of the treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Antispasticidal drug use Botulinum toxin injection into the gastrocnemius muscle Having another nervous system or orthopedic disease that can affect measurements
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Banu Dilek
Phone
+905052248340
Email
banu.dilek@deu.edu.tr
Facility Information:
Facility Name
Dokuz Eylul University
City
Izmir
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Banu Dilek
Email
banu.dilek@deu.edu.tr

12. IPD Sharing Statement

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

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