Cold Therapy and Cross-Education of Muscle Strength

NCT04886843 | Completed

• 1 other identifier: IstanbulPMRTRH-ct
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebrovascular Stroke; Muscle Weakness

Keywords

Cold therapy; Cross-education; Neuromuscular electrical stimulation; Hemiplegia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change of Lower Extremity Brunnstrom Score

  Change from Baseline Lower Extremity Brunnstrom Score at 6 days

• Change of Modified Ashworth Scale Score

  Change from Baseline Modified Ashworth Scale Score at 6 days

• Change of Functional Ambulation Scale Score

  Change from Baseline Functional Ambulation Scale Score at 6 days

• Change of Timed Up and Go Test Score

  Change from Baseline Change of Timed Up and Go Test Score at 6 days

Study Arms (2)

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.

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.

Device: NMES

Interventions

Cold pack OTHER

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

Cold Therapy

NMES DEVICE

NMES was applied to the nonaffected side ankle dorsiflexors

Cold Therapy; Control

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Physical Medicine Rehabilitation Training and Research Hospital: lead

Study Sites (1)

Istanbul Physical Medicine Rehabilitation Training & Research Hospital

Istanbul, 34173, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 21496110 BACKGROUND

• 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.

  PMID: 17190532 BACKGROUND

• 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.

  PMID: 23898251 BACKGROUND

• 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.

  PMID: 26907193 BACKGROUND

• 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.

  PMID: 28325123 BACKGROUND

• 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.

  PMID: 25218791 BACKGROUND

MeSH Terms

Conditions

Stroke; Muscle Weakness; Hemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Paralysis

Study Officials

• Ilhan Karacan, Assoc Prof

  Istanbul Physical Medicine Rehabilitation Training & Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: May 9, 2021
• First Posted: May 14, 2021
• Study Start: January 23, 2020
• Primary Completion: October 30, 2020
• Study Completion: October 30, 2020
• Last Updated: May 14, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)