Mirror Therapy and Cross-Education of Muscle Strength

Not Applicable

Completed

• Conditions: Muscle Weakness; Cerebrovascular Stroke
• Interventions: Device: Control; Device: Mirror frame

• Registration Number: NCT04887376
• Lead Sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2020-02-01
• Primary Completion: 2021-01-31
• Study Completion: 2021-01-31
• Status Verified: 2021-05
• Study First Submitted: 2021-05-07
• Study First Submitted QC: 2021-05-11
• Last Update Submitted: 2021-05-11
• Study First Posted: 2021-05-14
• Last Update Posted: 2021-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	Participants were asked to sit with their knee joints in full extension and both ankle joints in a neutral position. Five sessions of neuromuscular electrical stimulation (NMES) were applied to the non-affected side ankle dorsiflexors.
Mirror Therapy	Mirror frame	Participants were asked to sit with their knee joints in full extension and both ankle joints in a neutral position. Five sessions of neuromuscular electrical stimulation (NMES) were applied to the non-affected side ankle dorsiflexors. In addition to this application, mirror therapy was applied simultaneously with NMES.

Primary Outcome Measures

Name	Time	Method
Change of ankle dorsiflexor isometric muscle strength	Change from Baseline muscle strength at 6 days	Force transducer used for measuring maximum voluntary ankle dorsiflexion force. The force unit is kilogram.force

Secondary Outcome Measures

Name	Time	Method
Change of Lower Extremity Brunnstrom score	Change from Baseline Brunnstrom score at 6 days	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 of Functional Ambulation Scale score	Change from Baseline Functional Ambulation Scale score at 6 days	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 of Modified Ashworth Scale score	Change from Baseline Modified Ashworth Scale score at 6 days	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 of Timed Up and Go Test score	Change from Baseline Timed Up and Go Test score at 6 days	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.

Trial Locations

Locations (1)

Istanbul Physical Medicine Rehabilitation Training & Research Hospital; 🇹🇷 Istanbul, Turkey