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

Primary Purpose

HEMIPLEGIC CEREBRAL PALSY

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
MIRROR THERAPY
Sponsored by
South Valley University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HEMIPLEGIC CEREBRAL PALSY focused on measuring cerebral palsy, balance, mirror therapy

Eligibility Criteria

8 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • South Valley University, Faculty of Physical Therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

the control group

the study group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Antro-posterior stability index
the ability of child to maintain his balance from forward to backward direction
Antro-posterior stability index
the ability of child to maintain his balance from forward to backward direction
Over All Stability Index
the ability of child to maintain his balance in all directions
Over All Stability Index
the ability of child to maintain his balance in all directions
Mediolateral Stability Index
the ability of child to maintain his balance from side to side directions
Mediolateral Stability Index
the ability of child to maintain his balance from side to side directions

Secondary Outcome Measures

Full Information

First Posted
January 4, 2020
Last Updated
January 9, 2020
Sponsor
South Valley University
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1. Study Identification

Unique Protocol Identification Number
NCT04227262
Brief Title
Efficacy of Lower Extremity Mirror Therapy on Balance in Children With Hemiplegic Cerebral Palsy
Official Title
EFFICACY OF LOWER EXTREMITY MIRROR THERAPY ON BALANCE IN CHILDREN WITH HEMIPLEGIC CEREBRAL PALSY: A Randomized Controlled Trail
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
March 1, 2020 (Anticipated)
Study Completion Date
March 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Valley University

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HEMIPLEGIC CEREBRAL PALSY
Keywords
cerebral palsy, balance, mirror therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Masking Description
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).
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
the control group
Arm Type
No Intervention
Arm Description
Group (a) control group received traditional physical therapy program.
Arm Title
the study group
Arm Type
Experimental
Arm Description
group (b) study group received the same traditional physical therapy program in addition to mirror therapy three times / weak for three successful months.
Intervention Type
Other
Intervention Name(s)
MIRROR THERAPY
Intervention Description
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).
Primary Outcome Measure Information:
Title
Antro-posterior stability index
Description
the ability of child to maintain his balance from forward to backward direction
Time Frame
Antro-posterior stability index will be assessed at day 0.
Title
Antro-posterior stability index
Description
the ability of child to maintain his balance from forward to backward direction
Time Frame
Antro-posterior stability index will be assessed at day 90.
Title
Over All Stability Index
Description
the ability of child to maintain his balance in all directions
Time Frame
Over All Stability Index will be assessed at day 0.
Title
Over All Stability Index
Description
the ability of child to maintain his balance in all directions
Time Frame
Over All Stability Index will be assessed at day 90.
Title
Mediolateral Stability Index
Description
the ability of child to maintain his balance from side to side directions
Time Frame
Mediolateral Stability Index will be assessed at day 0.
Title
Mediolateral Stability Index
Description
the ability of child to maintain his balance from side to side directions
Time Frame
Mediolateral Stability Index will be assessed at day 90.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nehad A. Abo-zaid, PhD
Organizational Affiliation
South Valley University, Faculty of Physical Therapy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohammed E. Ali, PhD student
Organizational Affiliation
South Valley University, Faculty of Physical Therapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
South Valley University, Faculty of Physical Therapy
City
Qinā
State/Province
Qina
ZIP/Postal Code
83523
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19454781
Citation
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.
Results Reference
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PubMed Identifier
29077129
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.
Results Reference
background
PubMed Identifier
15754176
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. doi: 10.1007/s00221-005-2226-9. Epub 2005 Mar 8.
Results Reference
background
PubMed Identifier
26254950
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.
Results Reference
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PubMed Identifier
27313338
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.
Results Reference
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PubMed Identifier
24032716
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.
Results Reference
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PubMed Identifier
18335358
Citation
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.
Results Reference
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PubMed Identifier
17481817
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. doi: 10.1016/j.neulet.2007.04.025. Epub 2007 Apr 19.
Results Reference
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PubMed Identifier
19433654
Citation
Cattaneo L, Rizzolatti G. The mirror neuron system. Arch Neurol. 2009 May;66(5):557-60. doi: 10.1001/archneurol.2009.41.
Results Reference
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PubMed Identifier
17134723
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. doi: 10.1016/j.jns.2006.10.011. Epub 2006 Nov 28.
Results Reference
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PubMed Identifier
17466722
Citation
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.
Results Reference
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Citation
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.
Results Reference
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Efficacy of Lower Extremity Mirror Therapy on Balance in Children With Hemiplegic Cerebral Palsy

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