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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04227262
Other study ID # P.T.REC/012/002575
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date December 1, 2019
Est. completion date March 31, 2020

Study information

Verified date January 2020
Source South Valley University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 70
Est. completion date March 31, 2020
Est. primary completion date March 1, 2020
Accepts healthy volunteers No
Gender All
Age group 8 Years to 12 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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).

Locations

Country Name City State
Egypt South Valley University, Faculty of Physical Therapy Qina Qina

Sponsors (1)

Lead Sponsor Collaborator
South Valley University

Country where clinical trial is conducted

Egypt, 

References & Publications (12)

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. — View Citation

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

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. — View Citation

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. Epub 2007 Apr 19. — View Citation

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. Epub 2005 Mar 8. — View Citation

Gstöttner 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. — View Citation

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. — View Citation

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. Review. — View Citation

Saghaei M. Random allocation software for parallel group randomized trials. BMC Med Res Methodol. 2004 Nov 9;4:26. — View Citation

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. Epub 2006 Nov 28. — View Citation

Sütbeyaz 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. — View Citation

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. — View Citation

* Note: There are 12 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Antro-posterior stability index the ability of child to maintain his balance from forward to backward direction Antro-posterior stability index will be assessed at day 0.
Primary Antro-posterior stability index the ability of child to maintain his balance from forward to backward direction Antro-posterior stability index will be assessed at day 90.
Primary Over All Stability Index the ability of child to maintain his balance in all directions Over All Stability Index will be assessed at day 0.
Primary Over All Stability Index the ability of child to maintain his balance in all directions Over All Stability Index will be assessed at day 90.
Primary Mediolateral Stability Index the ability of child to maintain his balance from side to side directions Mediolateral Stability Index will be assessed at day 0.
Primary Mediolateral Stability Index the ability of child to maintain his balance from side to side directions Mediolateral Stability Index will be assessed at day 90.
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