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Cerebrovascular StrokeNCT04887376

Mirror Therapy and Cross-Education of Muscle Strength

A study testing Mirror frame in people with Cerebrovascular Stroke and Muscle Weakness, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Cerebrovascular Stroke, Muscle Weakness
What is being tested?
Mirror frame
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
29 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Feb 2020to 31 Jan 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Istanbul Physical Medicine Rehabilitation Training & Research Hospital

    Istanbul, 34173

Other trials in Turkey (Türkiye)

About this study

Official title: Additive Effect of Mirror Therapy on Effects of Cross-Education of Muscle Strength of Neuromuscular Electrical Stimulation In Hemiplegic Patients

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.

Read the 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.

Being tested
Mirror frame, Control
Keywords
Cross-education, Neuromuscular electrical stimulation, Mirror Therapy
Medical subject headings
Stroke, Muscle Weakness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mirror frameDevice

    Combined Mirror and NMES therapy

  • ControlDevice

    Only NMES therapy

Study groups in NCT04887376
Study groupRoleWhat they receive
Mirror TherapyActive comparatorParticipants 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.
Receives: Device: Mirror frame
ControlPlacebo comparatorParticipants 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.
Receives: Device: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of ankle dorsiflexor isometric muscle strength

    Force transducer used for measuring maximum voluntary ankle dorsiflexion force. The force unit is kilogram.force

    Measured: Change from Baseline muscle strength at 6 days

Secondary outcomes (4)

  1. 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

    Measured: Change from Baseline Brunnstrom score at 6 days

  2. 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.

    Measured: Change from Baseline Modified Ashworth Scale score at 6 days

  3. 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).

    Measured: Change from Baseline Functional Ambulation Scale score at 6 days

  4. 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.

    Measured: Change from Baseline Timed Up and Go Test score at 6 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2021
  2. Study start1 Feb 2020
  3. Primary completion31 Jan 2021
  4. Study completion31 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled trial
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04887376
Sponsor's protocol ID
IstPMRTRH-MT
Status last verified
May 2021
First submitted
7 May 2021
Last updated
14 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 23898251

  • 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.

    PubMed 26765630

  • 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.

    PubMed 21496110

  • 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.

    PubMed 30916531

  • 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.

    PubMed 23867040

  • 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.

    PubMed 24764619

Questions about this trial

What is this clinical trial studying?

A study testing Mirror frame in people with Cerebrovascular Stroke and Muscle Weakness, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of ankle dorsiflexor isometric muscle strength (time frame: Change from Baseline muscle strength at 6 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04887376, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2021.

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