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NCT Number: NCT04886843

Cold Therapy and Cross-Education of Muscle Strength

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.

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Physical Medicine Rehabilitation Training & Research Hospital

Istanbul, 34173, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

NMES

Device

NMES was applied to the nonaffected side ankle dorsiflexors

Primary outcomes

  1. 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

Secondary outcomes

  1. Change of Lower Extremity Brunnstrom Score

    Time frame: Change from Baseline Lower Extremity Brunnstrom Score at 6 days

    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

  2. Change of Modified Ashworth Scale Score

    Time frame: Change from Baseline Modified Ashworth Scale Score at 6 days

    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

  3. Change of Functional Ambulation Scale Score

    Time frame: Change from Baseline Functional Ambulation Scale Score at 6 days

    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).

  4. Change of Timed Up and Go Test Score

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

    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.

Sponsors and collaborators

Lead sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 14, 2021
Registry last updated
May 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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