Cerebrovascular StrokeNCT04886843
Cold Therapy and Cross-Education of Muscle Strength
A study testing Cold pack and NMES in people with Cerebrovascular Stroke and Muscle Weakness, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate whether a cold application to the contralateral (affected side) extremity in addition to unilateral neuromuscular electrical stimulation (NMES) application has a facilitating effect on muscle strength in post-stroke hemiplegia patients. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cerebrovascular Stroke, Muscle Weakness
- What is being tested?
- Cold pack and NMES
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Jan 2020to 30 Oct 2020
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cases with stroke duration ≥1 month
- Brunnstrom stage ≥4 for lower limb
- Unilateral stroke
- Ability to walk at least 10 m (FAC ≥3)
- Cooperating with the examination and tests
Who cannot join
- Cold allergy
- Active inflammatory, rheumatological, or infectious disease
- Presence of lower extremity fracture
- Severe spasticity (MAS> 3) in ankle dorsiflexors
- Peripheral nerve lesions such as polyneuropathy, radiculopathy
- Parent rhythm/conduction block problem in the heart
Show all 10Show fewer
- Uncontrollable hypertension (Maxima >140 mmHg, Minima >90 mmHg)
- Have a contracture on the ankle joint
- The presence of skin lesions in the application area
- Finding or suspected active deep vein thrombosis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Physical Medicine Rehabilitation Training & Research Hospital
Istanbul, 34173
About this study
Official title: The Effects Of Cold Application To The Intact Side In Addition Cross Training With NMES On Dorsiflexor Muscle Strength In Hemiplegia
The aim of this study is to investigate whether a cold application to the contralateral (affected side) extremity in addition to unilateral neuromuscular electrical stimulation (NMES) application has a facilitating effect on muscle strength in post-stroke hemiplegia patients.
Read the detailed description
In this prospective randomized controlled single-blind study, a total of 25 patients, 16 men, and 9 women were included according to inclusion and exclusion criteria. Patients were randomly assigned to the experimental group (n=12) or the control group (n=13). NMES has applied to the non-affected side ankle dorsiflexors five sessions for a week in both groups. In addition to the experimental group, the cold application was applied on the affected side dorsiflexor muscle skin. The cold application was done on a moist towel for five minutes using a cold pack. A five-minute break was given and a further 5-minute cold application was repeated. The cold application was done simultaneously with NMES. A conventional rehabilitation program was applied to all patients by a physiotherapist. Before and after treatment, both ankle dorsiflexor strength was measured with a force sensor. For force measurements, a force transducer (FC2211-0000-0100-L Compression Load Cell, TE Connectivity company, France) was used. Force transducer signals were received with a data acquisition device (POWERLAB® data acquisition system ADInstruments, Oxford, UK) and evaluated offline on the computer. The measurement values were expressed in kilogram.force (kg.f) and this value was normalized according to body weight.
- Conditions
- Cerebrovascular Stroke, Muscle Weakness
- Being tested
- Cold pack, NMES
- Keywords
- Cold therapy, Cross-education, Neuromuscular electrical stimulation, Hemiplegia
- Medical subject headings
- Stroke, Muscle Weakness, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold packOther
Five minutes cold pack was applied on the affected side dorsiflexor muscle skin, a five-minute break was given and a further 5-minute cold application was repeated
NMESDevice
NMES was applied to the nonaffected side ankle dorsiflexors
| Study group | Role | What they receive |
|---|---|---|
| Cold Therapy | Active comparator | The patients have seated the knee joints in full extension and both ankle joints in a neutral position. Neuromuscular electrical stimulation (NMES) was applied to the non-affected side ankle dorsiflexors for five days, five sessions for a week. In addition to this application, a cold pack was applied on the affected side dorsiflexor muscle skin. The cold pack was applied on a moist towel for five minutes. A five-minute break was given and a further 5-minute cold application was repeated. The cold application was done simultaneously with NMES. Receives: Other: Cold pack; Device: NMES |
| Control | Placebo comparator | The patients have seated the knee joints in full extension and both ankle joints in a neutral position. Neuromuscular electrical stimulation (NMES) was applied to the non-affected side ankle dorsiflexors for five days, five sessions for a week. Receives: Device: NMES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of ankle dorsiflexor isometric muscle strength
Force transducer used for measuring maximum voluntary ankle dorsiflexion force. The force unit is kilogram.force
Measured: Change from Baseline ankle dorsiflexor isometric muscle strength at 6 days
Secondary outcomes (4)
Change of Lower Extremity Brunnstrom Score
This test describes the sequences of motor recovery after stroke based on the muscle tone, synergy patterns and isolated movements. Brunnstrom classified stages of recovery into six stages. Stage 1 and 6. Stage 1:Flaccidity; Stage 6: Spasticity disappears and individual joint movements become possible
Measured: Change from Baseline Lower Extremity Brunnstrom Score at 6 days
Change of Modified Ashworth Scale Score
The modified Ashworth scale is the tool used to measure the increase of muscle tone. The modified Ashworth scale is score is graded between 0 and 4. 0: No increase in muscle tone, 4: Affected part(s) rigid in flexion or extension
Measured: Change from Baseline Modified Ashworth Scale Score at 6 days
Change of Functional Ambulation Scale Score
The Functional Ambulation Classification (FAC) is a functional walking test that evaluates ambulation ability. Patients are categorized between 0 (non-functional ambulation) and 6 (independent).
Measured: Change from Baseline Functional Ambulation Scale Score at 6 days
Change of Timed Up and Go Test Score
The Timed Up and Go Test (TUG) assesses mobility, balance, walking ability, and fall risk. It uses the time that a person takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees.
Measured: Change from Baseline Change of Timed Up and Go Test Score at 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start23 Jan 2020
- Primary completion30 Oct 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular StrokeStudies 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
- Model description
- Randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ilhan Karacan, Assoc Prof, Principal investigator, Istanbul Physical Medicine Rehabilitation Training & Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04886843
- Sponsor's protocol ID
- IstanbulPMRTRH-ct
- Status last verified
- May 2021
- First submitted
- 9 May 2021
- Last updated
- 14 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sariyildiz M, Karacan I, Rezvani A, Ergin O, Cidem M. Cross-education of muscle strength: cross-training effects are not confined to untrained contralateral homologous muscle. Scand J Med Sci Sports. 2011 Dec;21(6):e359-64. doi: 10.1111/j.1600-0838.2011.01311.x. Epub 2011 Apr 18.
PubMed 21496110Lee M, Carroll TJ. Cross education: possible mechanisms for the contralateral effects of unilateral resistance training. Sports Med. 2007;37(1):1-14. doi: 10.2165/00007256-200737010-00001.
PubMed 17190532Howatson G, Zult T, Farthing JP, Zijdewind I, Hortobagyi T. Mirror training to augment cross-education during resistance training: a hypothesis. Front Hum Neurosci. 2013 Jul 24;7:396. doi: 10.3389/fnhum.2013.00396. eCollection 2013.
PubMed 23898251Ehrensberger M, Simpson D, Broderick P, Monaghan K. Cross-education of strength has a positive impact on post-stroke rehabilitation: a systematic literature review. Top Stroke Rehabil. 2016 Apr;23(2):126-35. doi: 10.1080/10749357.2015.1112062. Epub 2016 Feb 24.
PubMed 26907193Tokunaga T, Sugawara H, Tadano C, Muro M. Effect of stimulation of cold receptors with menthol on EMG activity of quadriceps muscle during low load contraction. Somatosens Mot Res. 2017 Jun;34(2):85-91. doi: 10.1080/08990220.2017.1299004. Epub 2017 Mar 21.
PubMed 28325123Shimose R, Ushigome N, Tadano C, Sugawara H, Yona M, Matsunaga A, Muro M. Increase in rate of force development with skin cooling during isometric knee extension. J Electromyogr Kinesiol. 2014 Dec;24(6):895-901. doi: 10.1016/j.jelekin.2014.08.002. Epub 2014 Aug 24.
PubMed 25218791
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects Of Cold Application To The Intact Side In Addition Cross Training With NMES On Dorsiflexor Muscle Strength In Hemiplegia
- ClinicalTrials.gov ID
- NCT04886843
- Acronym / sponsor ID
- IstanbulPMRTRH-ct
- Conditions
- Cerebrovascular Stroke, Muscle Weakness
- Keywords
- Cold therapy, Cross-education, Neuromuscular electrical stimulation, Hemiplegia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 23 Jan 2020 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 14 May 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.
The aim of this study is to investigate whether a cold application to the contralateral (affected side) extremity in addition to unilateral neuromuscular electrical stimulation (NMES) application has a facilitating effect on muscle strength in post-stroke hemiplegia patients.
Detailed description
In this prospective randomized controlled single-blind study, a total of 25 patients, 16 men, and 9 women were included according to inclusion and exclusion criteria. Patients were randomly assigned to the experimental group (n=12) or the control group (n=13). NMES has applied to the non-affected side ankle dorsiflexors five sessions for a week in both groups. In addition to the experimental group, the cold application was applied on the affected side dorsiflexor muscle skin. The cold application was done on a moist towel for five minutes using a cold pack. A five-minute break was given and a further 5-minute cold application was repeated. The cold application was done simultaneously with NMES. A conventional rehabilitation program was applied to all patients by a physiotherapist. Before and after treatment, both ankle dorsiflexor strength was measured with a force sensor. For force measurements, a force transducer (FC2211-0000-0100-L Compression Load Cell, TE Connectivity company, France) was used. Force transducer signals were received with a data acquisition device (POWERLAB® data acquisition system ADInstruments, Oxford, UK) and evaluated offline on the computer. The measurement values were expressed in kilogram.force (kg.f) and this value was normalized according to body weight.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Cold Therapy | Active comparator | Other: Cold pack, Device: NMESThe patients have seated the knee joints in full extension and both ankle joints in a neutral position. Neuromuscular electrical stimulation (NMES) was applied to the non-affected side ankle dorsiflexors for five days, five sessions for a week. In addition to this application, a cold pack was applied on the affected side dorsiflexor muscle skin. The cold pack was applied on a moist towel for five minutes. A five-minute break was given and a further 5-minute cold application was repeated. The cold application was done simultaneously with NMES. |
| Control | Placebo comparator | Device: NMESThe patients have seated the knee joints in full extension and both ankle joints in a neutral position. Neuromuscular electrical stimulation (NMES) was applied to the non-affected side ankle dorsiflexors for five days, five sessions for a week. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Cases with stroke duration ≥1 month
- Brunnstrom stage ≥4 for lower limb
- Unilateral stroke
- Ability to walk at least 10 m (FAC ≥3)
- Cooperating with the examination and tests
Key exclusion criteria (10 listed)
- Cold allergy
- Active inflammatory, rheumatological, or infectious disease
- Presence of lower extremity fracture
- Severe spasticity (MAS> 3) in ankle dorsiflexors
- Peripheral nerve lesions such as polyneuropathy, radiculopathy
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 |
|---|---|---|
| Cold packFive minutes cold pack was applied on the affected side dorsiflexor muscle skin, a five-minute break was given and a further 5-minute cold application was repeated | Other | Cold Therapy |
| NMESNMES was applied to the nonaffected side ankle dorsiflexors | Device | Cold Therapy, Control |
Primary outcome
Change of ankle dorsiflexor isometric muscle strength
Time frame: Change from Baseline ankle dorsiflexor isometric muscle strength at 6 days
Force transducer used for measuring maximum voluntary ankle dorsiflexion force. The force unit is kilogram.force
4 secondary outcomes
Change of Lower Extremity Brunnstrom Score
Time frame: Change from Baseline Lower Extremity Brunnstrom Score at 6 days
Change of Modified Ashworth Scale Score
Time frame: Change from Baseline Modified Ashworth Scale Score at 6 days
Change of Functional Ambulation Scale Score
Time frame: Change from Baseline Functional Ambulation Scale Score at 6 days
Change of Timed Up and Go Test Score
Time frame: Change from Baseline Change of Timed Up and Go Test Score at 6 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
- Background: PubMed 21496110Sariyildiz M, Karacan I, Rezvani A, Ergin O, Cidem M. Cross-education of muscle strength: cross-training effects are not confined to untrained contralateral homologous muscle. Scand J Med Sci Sports. 2011 Dec;21(6):e359-64. doi: 10.1111/j.1600-0838.2011.01311.x. Epub 2011 Apr 18.
- Background: PubMed 17190532Lee M, Carroll TJ. Cross education: possible mechanisms for the contralateral effects of unilateral resistance training. Sports Med. 2007;37(1):1-14. doi: 10.2165/00007256-200737010-00001.
- Background: PubMed 23898251Howatson G, Zult T, Farthing JP, Zijdewind I, Hortobagyi T. Mirror training to augment cross-education during resistance training: a hypothesis. Front Hum Neurosci. 2013 Jul 24;7:396. doi: 10.3389/fnhum.2013.00396. eCollection 2013.
- Background: PubMed 26907193Ehrensberger M, Simpson D, Broderick P, Monaghan K. Cross-education of strength has a positive impact on post-stroke rehabilitation: a systematic literature review. Top Stroke Rehabil. 2016 Apr;23(2):126-35. doi: 10.1080/10749357.2015.1112062. Epub 2016 Feb 24.
- Background: PubMed 28325123Tokunaga T, Sugawara H, Tadano C, Muro M. Effect of stimulation of cold receptors with menthol on EMG activity of quadriceps muscle during low load contraction. Somatosens Mot Res. 2017 Jun;34(2):85-91. doi: 10.1080/08990220.2017.1299004. Epub 2017 Mar 21.
- Background: PubMed 25218791Shimose R, Ushigome N, Tadano C, Sugawara H, Yona M, Matsunaga A, Muro M. Increase in rate of force development with skin cooling during isometric knee extension. J Electromyogr Kinesiol. 2014 Dec;24(6):895-901. doi: 10.1016/j.jelekin.2014.08.002. Epub 2014 Aug 24.
- Individual participant dataSharing planned: No
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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.
Ilhan Karacan, Assoc Prof principal investigator
Istanbul Physical Medicine Rehabilitation Training & Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold pack and NMES in people with Cerebrovascular Stroke and Muscle Weakness, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital 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 5 inclusion and 10 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: finished, as of the sponsor's last update on 14 May 2021. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of ankle dorsiflexor isometric muscle strength (time frame: Change from Baseline ankle dorsiflexor isometric muscle strength at 6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04886843, which also lists 6 linked publications.
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 14 May 2021.