Cold Therapy and Cross-Education of Muscle Strength

Muscle Weakness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04886843
• Other study ID #: IstanbulPMRTRH-ct
• Status: Completed
• Phase: N/A
• Start date: January 23, 2020
• Est. completion date: October 30, 2020

Study information

• Verified date: May 2021
• Source: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 30, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebrovascular Stroke
• Muscle Weakness
• Stroke

Intervention

Other:
• Cold pack
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

Device:
• NMES
NMES was applied to the nonaffected side ankle dorsiflexors

Locations

Country	Name	City	State
Turkey	Istanbul Physical Medicine Rehabilitation Training & Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

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. Review. — View Citation

Howatson G, Zult T, Farthing JP, Zijdewind I, Hortobágyi 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. — View Citation

Lee M, Carroll TJ. Cross education: possible mechanisms for the contralateral effects of unilateral resistance training. Sports Med. 2007;37(1):1-14. Review. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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