Spastic HemiplegiaNCT04775511
Clinical and Ultrasonographic Comparison of the Effect of Hot and Cold Therapy on Spasticity
A study testing Heat Therapy with heating pads, Cold Therapy with ice packs and Stretching Exercises in people with Spastic Hemiplegia, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spastic Hemiplegia
- What is being tested?
- Heat Therapy with heating pads, Cold Therapy with ice packs and Stretching Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Feb 2021to 1 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Antispasticidal drug use
- Botulinum toxin injection into the gastrocnemius muscle
- Having another nervous system or orthopedic disease that can affect measurements
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Dokuz Eylul University
Izmir
Banu Dilek, banu.dilek@deu.edu.tr
About this study
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.
Read the 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.
- Conditions
- Spastic Hemiplegia
- Being tested
- Heat Therapy with heating pads, Cold Therapy with ice packs, Stretching Exercises
- Keywords
- spastisity, ultrasonography, hot pack, cold pack
- Medical subject headings
- Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heat Therapy with heating padsOther
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 packsOther
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 ExercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Stretching Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medial gastrokinemius muscle via ultrasonographic measurement
Change of the medial gastrocinemius pennat angle, medial muscle fascicule length, achilles tendon length
Measured: 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
Ankle dorsiflexion will be measured by goniometry in knee extension and flexion.
Measured: 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
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.)
Measured: All patients will be evaluated for 3 times; before treatment, first day of the treatment and fifth day of the treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start22 Feb 2021
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spastic HemiplegiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Banu Dilek, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04775511
- Sponsor's protocol ID
- DokuzUS
- Status last verified
- May 2022
- First submitted
- 29 Feb 2020
- Last updated
- 11 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Ultrasonographic Comparison of the Effect of Hot and Cold Therapy on Spasticity
- ClinicalTrials.gov ID
- NCT04775511
- Acronym / sponsor ID
- DokuzUS
- Conditions
- Spastic Hemiplegia
- Keywords
- spastisity, ultrasonography, hot pack, cold pack
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 1 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Heat Therapy with heating pads | Experimental | Other: Heat Therapy with heating pads20 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 | Experimental | Other: Cold Therapy with ice packs20 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 | Other | Other: Stretching Exercises20 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Antispasticidal drug use
- Botulinum toxin injection into the gastrocnemius muscle
- Having another nervous system or orthopedic disease that can affect measurements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heat Therapy with heating pads20 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 packs20 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 Exercises20 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 |
Primary outcome
Medial gastrokinemius muscle via ultrasonographic measurement
Time frame: All patients will be evaluated for 3 times; before treatment, first day of the treatment and fifth day of the treatment.
Change of the medial gastrocinemius pennat angle, medial muscle fascicule length, achilles tendon length
2 secondary outcomes
Change of the ankle range of motion
Time frame: 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
Time frame: All patients will be evaluated for 3 times; before treatment, first day of the treatment and fifth day of the treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
Related trials for Spastic Hemiplegia
Recruiting
rTMS Treatment of Spasticity in Children With Cerebral Palsy/ Hemiplegia Due to ABI - a RCT
CP (Cerebral Palsy)
Recruiting
ESTIM-UL: FES for Upper Limb Recovery After Stroke
Stroke, Post-Stroke Spasticity
RecruitingObservational study
Robot Aided Rehabilitation - Multi-joint Evaluations
Stroke
Recruiting
Clinical and Ultrasonographic Evaluation of the Efficacy of Extracorporeal Shock Wave Therapy (ESWT) in Post-Stroke Spasticity
Stroke, Spastic Hemiplegia
Active, not recruiting
Robot-Assisted Mirror Therapy in the Rehabilitation of Hemiparetic Cerebral Palsy
Cerebral Palsy (CP), Hemiparetic Cerebral Palsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heat Therapy with heating pads, Cold Therapy with ice packs and Stretching Exercises in people with Spastic Hemiplegia, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Banu Dilek (+905052248340, banu.dilek@deu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medial gastrokinemius muscle via ultrasonographic measurement (time frame: All patients will be evaluated for 3 times; before treatment, first day of the treatment and fifth day of the treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2022.