Clinical trial NCT04886843: Cold Therapy and Cross-Education of Muscle Strength
Official title: The Effects Of Cold Application To The Intact Side In Addition Cross Training With NMES On Dorsiflexor Muscle Strength In Hemiplegia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebrovascular Stroke
Muscle Weakness
Keywords: Cold therapy
Cross-education
Neuromuscular electrical stimulation
Hemiplegia
Lead sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2021-05-14
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of ankle dorsiflexor isometric muscle strength
timeFrame: Change from Baseline ankle dorsiflexor isometric muscle strength at 6 days
Secondary outcomes:
measure: Change of Lower Extremity Brunnstrom Score
timeFrame: Change from Baseline Lower Extremity Brunnstrom Score at 6 days
measure: Change of Modified Ashworth Scale Score
timeFrame: Change from Baseline Modified Ashworth Scale Score at 6 days
measure: Change of Functional Ambulation Scale Score
timeFrame: Change from Baseline Functional Ambulation Scale Score at 6 days
measure: Change of Timed Up and Go Test Score
timeFrame: Change from Baseline Change of Timed Up and Go Test Score at 6 days
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Physical Medicine Rehabilitation Training & Research Hospital
Study officials:
affiliation: Istanbul Physical Medicine Rehabilitation Training & Research Hospital
name: Ilhan Karacan, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Lee 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.
citation: Howatson 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.
citation: Ehrensberger 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.
citation: Tokunaga 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.
citation: Shimose 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.