NCT04887376

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 14, 2021

Completed
Last Updated

May 14, 2021

Status Verified

May 1, 2021

Enrollment Period

1 year

First QC Date

May 7, 2021

Last Update Submit

May 11, 2021

Conditions

Keywords

Cross-educationNeuromuscular electrical stimulationMirror Therapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change of Lower Extremity Brunnstrom score

    Change from Baseline Brunnstrom score at 6 days

  • Change of Modified Ashworth Scale score

    Change from Baseline Modified Ashworth Scale score at 6 days

  • Change of Functional Ambulation Scale score

    Change from Baseline Functional Ambulation Scale score at 6 days

  • Change of Timed Up and Go Test score

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

Study Arms (2)

Mirror Therapy

ACTIVE COMPARATOR

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.

Device: Mirror frame

Control

PLACEBO COMPARATOR

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.

Device: Control

Interventions

Combined Mirror and NMES therapy

Mirror Therapy
ControlDEVICE

Only NMES therapy

Control

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Physical Medicine Rehabilitation Training & Research Hospital

Istanbul, 34173, Turkey (Türkiye)

Location

Related Publications (6)

  • 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.

    PMID: 23898251BACKGROUND
  • 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.

    PMID: 26765630BACKGROUND
  • 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.

    PMID: 21496110BACKGROUND
  • 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.

    PMID: 30916531BACKGROUND
  • 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.

    PMID: 23867040BACKGROUND
  • 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.

    PMID: 24764619BACKGROUND

MeSH Terms

Conditions

StrokeMuscle Weakness

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesMuscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Ilhan Karacan, Assoc Prof

    Istanbul Physical Medicine Rehabilitation Training & Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2021

First Posted

May 14, 2021

Study Start

February 1, 2020

Primary Completion

January 31, 2021

Study Completion

January 31, 2021

Last Updated

May 14, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations