Clinical trial NCT04113369: Upper Limb Cross-education in Subacute Stroke
Official title: How Does Cross-education Affect Muscles of Paretic Upper Extremity in Subacute Stroke Survivors?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiplegia
Stroke
Keywords: Cross-education
Interlimb transfer
Electro muscular stimulation
Muscle strength
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2019-10-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: The Fugl-Meyer motor function assessment for upper extremity
timeFrame: 6 weeks
measure: The functional independence measure
timeFrame: 6 weeks
measure: Brunnstrom stage of recovery for hand
timeFrame: 6 weeks
measure: Maximum and mean strength of paretic wrist flexors
timeFrame: 6 weeks
measure: Maximum and mean strength of paretic wrist extensors
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem University
Study officials:
affiliation: Bezmialem University
name: Ozan Volkan Yurdakul, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carroll TJ, Herbert RD, Munn J, Lee M, Gandevia SC. Contralateral effects of unilateral strength training: evidence and possible mechanisms. J Appl Physiol (1985). 2006 Nov;101(5):1514-22. doi: 10.1152/japplphysiol.00531.2006.
citation: Dragert K, Zehr EP. High-intensity unilateral dorsiflexor resistance training results in bilateral neuromuscular plasticity after stroke. Exp Brain Res. 2013 Mar;225(1):93-104. doi: 10.1007/s00221-012-3351-x. Epub 2012 Nov 30.
citation: Urbin MA, Harris-Love ML, Carter AR, Lang CE. High-Intensity, Unilateral Resistance Training of a Non-Paretic Muscle Group Increases Active Range of Motion in a Severely Paretic Upper Extremity Muscle Group after Stroke. Front Neurol. 2015 May 27;6:119. doi: 10.3389/fneur.2015.00119. eCollection 2015.
citation: Yurdakul OV, Kilicoglu MS, Rezvani A, Kucukakkas O, Eren F, Aydin T. How does cross-education affects muscles of paretic upper extremity in subacute stroke survivors? Neurol Sci. 2020 Dec;41(12):3667-3675. doi: 10.1007/s10072-020-04506-2. Epub 2020 Jun 6.