Cold Therapy and Cross-Education of Muscle Strength

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effects Of Cold Application To The Intact Side In Addition Cross Training With NMES On Dorsiflexor Muscle Strength In Hemiplegia

Conditions
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Muscle Weakness, Cerebrovascular Stroke

Intervention / Treatment
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* Other: Cold pack
* Device: NMES


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cold Therapy<br>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. | Other: Cold pack<br>* 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<br>Device: NMES<br>* NMES was applied to the nonaffected side ankle dorsiflexors<br>|
| Placebo Comparator: Control<br>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. | Device: NMES<br>* NMES was applied to the nonaffected side ankle dorsiflexors<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of ankle dorsiflexor isometric muscle strength | Force transducer used for measuring maximum voluntary ankle dorsiflexion force. The force unit is kilogram.force | Change from Baseline ankle dorsiflexor isometric muscle strength at 6 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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). | 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. | Change from Baseline Change of Timed Up and Go Test Score at 6 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cold therapy, Cross-education, Neuromuscular electrical stimulation, Hemiplegia