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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04887376
Other study ID # IstPMRTRH-MT
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2020
Est. completion date January 31, 2021

Study information

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

Clinical Trial Summary

This study was conducted to determine whether mirror therapy has an additive effect on cross-education of the strength of neuromuscular electrical stimulation (NMES) in patients with hemiplegia. As an outcome measure, the ankle dorsiflexion strength of hemiplegic patients was measured.


Description:

A total of 29 patients, 7 women, and 22 men were included according to the inclusion and exclusion criteria. The patients were randomly assigned to the control group (n = 14) and the Mirror group (n = 15). Five sessions of neuromuscular electrical stimulation, unaffected side ankle dorsiflexors were applied to the patients in both groups. In addition to the NMES, mirror therapy was applied to the experimental group simultaneously with NMES. 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 29
Est. completion date January 31, 2021
Est. primary completion date January 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Cases with stroke duration = 1 month - Ability to walk at least 10m (functional ambulation scale =3) - Age range 18-75 years - Hemorrhagic or ischemic stroke - Brunnstrom stage =4 for lower limb - Unilateral stroke - Cooperating with the examination and tests Exclusion Criteria: - Mini Mental State Assessment score <21 - Severe spasticity (MAS = 4) in ankle dorsiflexors - Have a contracture on ankle joint - The presence of skin lesions in the application area - Painful pathologies in the lower extremities - Having visual field defects - Active inflammatory, rheumatological or infectious disease - Parent rhythm / conduction block problem in the heart - Uncontrollable hypertension (Maxima> 140, Minima> 90) - Presence of lower extremity fracture - Peripheral nerve lesions such as polyneuropathy, radiculopathy - Finding or suspected active deep vein thrombosis - History of deep vein thrombosis and pulmonary embolism

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Mirror frame
Combined Mirror and NMES therapy
Control
Only NMES therapy

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)

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

Ji SG, Cha HG, Kim MK, Lee CR. The effect of mirror therapy integrating functional electrical stimulation on the gait of stroke patients. J Phys Ther Sci. 2014 Apr;26(4):497-9. doi: 10.1589/jpts.26.497. Epub 2014 Apr 23. — View Citation

Kim H, Lee G, Song C. Effect of functional electrical stimulation with mirror therapy on upper extremity motor function in poststroke patients. J Stroke Cerebrovasc Dis. 2014 Apr;23(4):655-61. doi: 10.1016/j.jstrokecerebrovasdis.2013.06.017. Epub 2013 Jul 16. — View Citation

Lee D, Lee G. Effect of afferent electrical stimulation with mirror therapy on motor function, balance, and gait in chronic stroke survivors: a randomized controlled trial. Eur J Phys Rehabil Med. 2019 Aug;55(4):442-449. doi: 10.23736/S1973-9087.19.05334-6. Epub 2019 Mar 22. — 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

Zult T, Goodall S, Thomas K, Solnik S, Hortobágyi T, Howatson G. Mirror Training Augments the Cross-education of Strength and Affects Inhibitory Paths. Med Sci Sports Exerc. 2016 Jun;48(6):1001-13. doi: 10.1249/MSS.0000000000000871. — 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 muscle strength at 6 days
Secondary Change of Lower Extremity Brunnstrom score It evaluates the developmental stages of synergy patterns, muscle tone and isolated movements of the patients in the lower extremities. Patients are categorized between Stage-1 and 6. Stage 1: Flaccidity; Stage 6: Spasticity Disappears and Coordination Reappears Change from Baseline Brunnstrom score at 6 days
Secondary Change of Modified Ashworth Scale score Modified Ashworth Scale was used for assessment spasticity. Modified Ashworth Scale scores are varied between 0 and 4: 0 points, no increase in muscle tone; 4 points indicate spasticity with a degree of rigidity. Change from Baseline Modified Ashworth Scale score at 6 days
Secondary Change of Functional Ambulation Scale score The Functional Ambulation Classification (FAC) is a method for classifying mobility. The FAC has six categories ranging from 0 (non-functional ambulation) to 5 (independent). Change from Baseline Functional Ambulation Scale score at 6 days
Secondary Change of Timed Up and Go Test score It is a test that evaluates the patient's static and dynamic balance, mobility and walking ability. The test's score is the time in seconds it takes the subject takes to complete the test. Change from Baseline Timed Up and Go Test score at 6 days
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