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Mirror Therapy and Cross-Education of Muscle Strength

Primary Purpose

Cerebrovascular Stroke, Muscle Weakness

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Mirror frame
Control
Sponsored by
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebrovascular Stroke focused on measuring Cross-education, Neuromuscular electrical stimulation, Mirror Therapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istanbul Physical Medicine Rehabilitation Training & Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Mirror Therapy

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change of ankle dorsiflexor isometric muscle strength
Force transducer used for measuring maximum voluntary ankle dorsiflexion force. The force unit is kilogram.force

Secondary Outcome Measures

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 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 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 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.

Full Information

First Posted
May 7, 2021
Last Updated
May 11, 2021
Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04887376
Brief Title
Mirror Therapy and Cross-Education of Muscle Strength
Official Title
Additive Effect of Mirror Therapy on Effects of Cross-Education of Muscle Strength of Neuromuscular Electrical Stimulation In Hemiplegic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
January 31, 2021 (Actual)
Study Completion Date
January 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Stroke, Muscle Weakness
Keywords
Cross-education, Neuromuscular electrical stimulation, Mirror Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mirror Therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Mirror frame
Intervention Description
Combined Mirror and NMES therapy
Intervention Type
Device
Intervention Name(s)
Control
Intervention Description
Only NMES therapy
Primary Outcome Measure Information:
Title
Change of ankle dorsiflexor isometric muscle strength
Description
Force transducer used for measuring maximum voluntary ankle dorsiflexion force. The force unit is kilogram.force
Time Frame
Change from Baseline muscle strength at 6 days
Secondary Outcome Measure Information:
Title
Change of Lower Extremity Brunnstrom score
Description
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
Time Frame
Change from Baseline Brunnstrom score at 6 days
Title
Change of Modified Ashworth Scale score
Description
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.
Time Frame
Change from Baseline Modified Ashworth Scale score at 6 days
Title
Change of Functional Ambulation Scale score
Description
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).
Time Frame
Change from Baseline Functional Ambulation Scale score at 6 days
Title
Change of Timed Up and Go Test score
Description
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.
Time Frame
Change from Baseline Timed Up and Go Test score at 6 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilhan Karacan, Assoc Prof
Organizational Affiliation
Istanbul Physical Medicine Rehabilitation Training & Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul Physical Medicine Rehabilitation Training & Research Hospital
City
Istanbul
ZIP/Postal Code
34173
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23898251
Citation
Howatson G, Zult T, Farthing JP, Zijdewind I, Hortobagyi 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.
Results Reference
background
PubMed Identifier
26765630
Citation
Zult T, Goodall S, Thomas K, Solnik S, Hortobagyi 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.
Results Reference
background
PubMed Identifier
21496110
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.
Results Reference
background
PubMed Identifier
30916531
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.
Results Reference
background
PubMed Identifier
23867040
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.
Results Reference
background
PubMed Identifier
24764619
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.
Results Reference
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Mirror Therapy and Cross-Education of Muscle Strength

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