Efficacy of Lower Extremity Mirror Therapy on Balance in Children With Hemiplegic Cerebral Palsy

NCT ID: NCT04227262

Last Updated: 2020-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-01

Study Completion Date

2020-03-31

Brief Summary

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The study will be conducted to assess the efficacy of mirror therapy on balance in children with hemiplegic cerebral palsy.

Detailed Description

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Hemiplegic cerebral palsy in the most common type of cerebral palsy that has permanent motor disorders and associated with life-long disability. the aim of study to assess the efficacy of mirror therapy on balance in children with hemiplegic cerebral palsy. Seventy child with hemiplegic cerebral were enrolled in this study and were assessed for eligibility. Their aged ranged from eight to twelve years. The children were assigned randomly into two equal groups. Group (a) control group received traditional physical therapy program. And group (b) study group received the same traditional physical therapy program in addition to mirror therapy three times / weak for three successful months. Biodex balance system was used to assess balance pre and post treatment. All children were assisted before and after three months of intervention.

Conditions

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HEMIPLEGIC CEREBRAL PALSY

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The children were assigned randomly into two equal groups. Group (a) control group received traditional physical therapy program. And group (b) study group received the same traditional physical therapy program in addition to mirror therapy three times / weak for three successful months.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Blinding process to participants and care providers was impossible due to the nature of intervention therapy. Data were analyzed by an impartial statistician (outcomes assessor), referring to each arm with an encoded name: Group A (control group) and Group B (study group).

Study Groups

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the control group

Group (a) control group received traditional physical therapy program.

Group Type NO_INTERVENTION

No interventions assigned to this group

the study group

group (b) study group received the same traditional physical therapy program in addition to mirror therapy three times / weak for three successful months.

Group Type EXPERIMENTAL

MIRROR THERAPY

Intervention Type OTHER

The children were instructed to sitting on chair and a mirror is placed in midsagittal plane of the child, with the normal limb in front of mirror and the affected limb is blocked so the patient see only the reflected movement of the sound limb (non affected).

Interventions

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MIRROR THERAPY

The children were instructed to sitting on chair and a mirror is placed in midsagittal plane of the child, with the normal limb in front of mirror and the affected limb is blocked so the patient see only the reflected movement of the sound limb (non affected).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Children's aged ranged from eight to twelve years.
* Children participated in this study will from both sexes.
* Their degree of spasticity will ranged from mild to moderate according to Modified Ashworth Scale.
* Children with stable medical and psychological status.
* Children able to follow the verbal commands or instructions.

Exclusion Criteria

* children with visual or auditory problems.
* Children with history of epilepsy.
* Children with history of surgical interference in lower limbs less than one year.
* Medically unstable children especially with cardiovascular disorders.
* Mentally retarded children.
* un-cooperative children.
Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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South Valley University

OTHER

Sponsor Role lead

Responsible Party

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Mohammed E. Ali, Ph. D Candidate.

Assistant Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nehad A. Abo-zaid, PhD

Role: PRINCIPAL_INVESTIGATOR

South Valley University, Faculty of Physical Therapy

Mohammed E. Ali, PhD student

Role: PRINCIPAL_INVESTIGATOR

South Valley University, Faculty of Physical Therapy

Locations

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South Valley University, Faculty of Physical Therapy

Qina, Qena Governorate, Egypt

Site Status

Countries

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Egypt

References

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Gstottner M, Neher A, Scholtz A, Millonig M, Lembert S, Raschner C. Balance ability and muscle response of the preferred and nonpreferred leg in soccer players. Motor Control. 2009 Apr;13(2):218-31. doi: 10.1123/mcj.13.2.218.

Reference Type BACKGROUND
PMID: 19454781 (View on PubMed)

Zeng W, Guo Y, Wu G, Liu X, Fang Q. Mirror therapy for motor function of the upper extremity in patients with stroke: A meta-analysis. J Rehabil Med. 2018 Jan 10;50(1):8-15. doi: 10.2340/16501977-2287.

Reference Type BACKGROUND
PMID: 29077129 (View on PubMed)

Garry MI, Loftus A, Summers JJ. Mirror, mirror on the wall: viewing a mirror reflection of unilateral hand movements facilitates ipsilateral M1 excitability. Exp Brain Res. 2005 May;163(1):118-22. doi: 10.1007/s00221-005-2226-9. Epub 2005 Mar 8.

Reference Type BACKGROUND
PMID: 15754176 (View on PubMed)

McInnes K, Friesen C, Boe S. Specific Brain Lesions Impair Explicit Motor Imagery Ability: A Systematic Review of the Evidence. Arch Phys Med Rehabil. 2016 Mar;97(3):478-489.e1. doi: 10.1016/j.apmr.2015.07.012. Epub 2015 Aug 5.

Reference Type BACKGROUND
PMID: 26254950 (View on PubMed)

Kenis-Coskun O, Giray E, Eren B, Ozkok O, Karadag-Saygi E. Evaluation of postural stability in children with hemiplegic cerebral palsy. J Phys Ther Sci. 2016 May;28(5):1398-402. doi: 10.1589/jpts.28.1398. Epub 2016 May 31.

Reference Type RESULT
PMID: 27313338 (View on PubMed)

El-Shamy SM, Abd El Kafy EM. Effect of balance training on postural balance control and risk of fall in children with diplegic cerebral palsy. Disabil Rehabil. 2014;36(14):1176-83. doi: 10.3109/09638288.2013.833312. Epub 2013 Sep 13.

Reference Type RESULT
PMID: 24032716 (View on PubMed)

Altschuler EL, Hu J. Mirror therapy in a patient with a fractured wrist and no active wrist extension. Scand J Plast Reconstr Surg Hand Surg. 2008;42(2):110-1. doi: 10.1080/02844310701510355.

Reference Type RESULT
PMID: 18335358 (View on PubMed)

Funase K, Tabira T, Higashi T, Liang N, Kasai T. Increased corticospinal excitability during direct observation of self-movement and indirect observation with a mirror box. Neurosci Lett. 2007 May 29;419(2):108-12. doi: 10.1016/j.neulet.2007.04.025. Epub 2007 Apr 19.

Reference Type RESULT
PMID: 17481817 (View on PubMed)

Cattaneo L, Rizzolatti G. The mirror neuron system. Arch Neurol. 2009 May;66(5):557-60. doi: 10.1001/archneurol.2009.41.

Reference Type RESULT
PMID: 19433654 (View on PubMed)

Summers JJ, Kagerer FA, Garry MI, Hiraga CY, Loftus A, Cauraugh JH. Bilateral and unilateral movement training on upper limb function in chronic stroke patients: A TMS study. J Neurol Sci. 2007 Jan 15;252(1):76-82. doi: 10.1016/j.jns.2006.10.011. Epub 2006 Nov 28.

Reference Type RESULT
PMID: 17134723 (View on PubMed)

Sutbeyaz S, Yavuzer G, Sezer N, Koseoglu BF. Mirror therapy enhances lower-extremity motor recovery and motor functioning after stroke: a randomized controlled trial. Arch Phys Med Rehabil. 2007 May;88(5):555-9. doi: 10.1016/j.apmr.2007.02.034.

Reference Type RESULT
PMID: 17466722 (View on PubMed)

Saghaei M. Random allocation software for parallel group randomized trials. BMC Med Res Methodol. 2004 Nov 9;4:26. doi: 10.1186/1471-2288-4-26.

Reference Type RESULT
PMID: 15535880 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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P.T.REC/012/002575

Identifier Type: -

Identifier Source: org_study_id

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