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NCT Number: NCT04113369

Upper Limb Cross-education in Subacute Stroke

This study evaluates how cross-education (unilateral training) affects muscle strength of the paretic limb in acute stroke patients. Half of the hemiplegic patients will receive conventional treatment and transcutaneous electrical nerve stimulation (TENS) to non-paretic side, while other half will receive conventional treatment and electro muscular stimulation (EMS) to non-paretic side.

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Key information

Conditions

Hemiplegia Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bezmialem University

Istanbul, 34093, Turkey (Türkiye)

About this study

Cross-education, which means the performance improvement in the untrained homologous muscle after unilateral exercise training, is studied in various orthopedical and neurological conditions affecting the body unilaterally. For those with asymmetrical weakness and immobility after stroke, training the non-paretic side can be utilized to increase the strength of the paretic side and improve functional symmetry. In this study, investigators aim was to examine whether training non-paretic upper extremity wrist flexor muscles by EMS in adjunct to conventional training program, has additional benefits upon the muscle powers of the homologous agonist and antagonist muscles. Investigators will use low frequency antalgic TENS stimulation at barely sensible level, which is considered not to cause muscle strengthening, as a control intervention.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • thromboembolic stroke,
  • <6 months of stroke,
  • right hand dominancy,
  • left hemiplegia,
  • Brunnstrom stage ≥ 3 of recovery for upper extremity and hand

Exclusion criteria

  • myopathy, tendinopathy, peripheral neuropathy of the upper extremities,
  • auditory, cognitive or speech disorder that enables communication,
  • history of fracture or arthrodesis in the upper limb,
  • contracture or severe spasticity (Ashworth scale ≥ 2) in forearm muscles,
  • severe cardiovascular disorders (heart failure, coronary artery disease, drug resistant hypertension)

Treatment and study plan

TENS

Device

30 minutes of conventional antalgic TENS to non-paretic forearm

conventional rehabilitation

Procedure

40 minutes of lower limb training and 20 minutes of upper extremity training for stroke

EMS

Device

20 minutes of EMS to non-paretic forearm with 5 minutes of pre and post warm-up

Primary outcomes

  1. The Fugl-Meyer motor function assessment for upper extremity

    Time frame: 6 weeks

    This scale is designed to assess reflex activity, volitional activities (within synergies, mixing synergies, with little or no synergy), wrist and hand joint functioning, and coordination of the upper extremity in patients with post-stroke hemiplegia. This scale is an ordinal scale that has 3 points for each item. A zero score is given for the item if the subject cannot do the task. A score of 1 is given when the task is performed partially and a score of 2 is given when the task is performed fully. However, reflex activity is measured using 2 points only, with a score of 0 or 2 for absence and presence of reflex respectively. Maximum score in the upper limb is 66 and higher scores represent a better outcome

  2. The functional independence measure

    Time frame: 6 weeks

    This scale is an assessment tool which evaluate the functional status of patients throughout the rehabilitation process. Degree of disability depends on the patient's score in 18 categories, focusing on motor and cognitive function. Each category or item is rated on a 7-point scale (1 = <25% independence; total assistance required, 7 = 100% independence. Total score varies between 18 to 126 and higher scores represent a more independent patient

  3. Brunnstrom stage of recovery for hand

    Time frame: 6 weeks

    This staging evaluates patient according to six sequential stages of recovery as stage 1: flaccidity, 2: basic limb synergy with minimal spasticity, 3: synergy with marked spasticity, 4: limited ability to move normally with reduced spasticity, 5: complex movement combinations, and 6: motor control is almost fully recovered. A patient can plateau at any stage but if able to reach stage 6 he or she makes full recovery

  4. Maximum and mean strength of paretic wrist flexors

    Time frame: 6 weeks

    While the patient lays in supine on a bad, a physician stabilizes the forearm of the patient and measures the wrist flexion power with a manual muscle tester device while patient's forearm is in supination. This device can measure maximal power and mean power during 10 seconds of pressure. Circular cap of the device is used as application surface and the cap is placed on palm for wrist flexion for measurement. Then the patient is asked to perform a maximum wrist flexion for ten seconds. The device notices the patient for time with two sounds at starting or finishing the measurement. The maximum and mean wrist flexion force, wrist extension force is recorded in kilograms after the measurement.

  5. Maximum and mean strength of paretic wrist extensors

    Time frame: 6 weeks

    While the patient lays in supine on a bad, a physician stabilizes the forearm of the patient and measures the wrist extension power with a manual muscle tester (Lafayette instrument company, IN, USA) device while patient's forearm is in pronation. This device can measure maximal power and mean power during 10 seconds of pressure. Circular cap of the device is used as application surface and the cap is placed on the middle of hand dorsum for wrist extension measurement. Then the patient is asked to perform a maximum wrist extension for ten seconds. The device notices the patient for time with two sounds at starting or finishing the measurement. The maximum and mean extension flexion force is recorded in kilograms after the measurement

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

How Does Cross-education Affect Muscles of Paretic Upper Extremity in Subacute Stroke Survivors?

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 2, 2019
Registry last updated
Apr 10, 2020

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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