NCT04227262

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

December 1, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 4, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

3 months

First QC Date

January 4, 2020

Last Update Submit

January 9, 2020

Conditions

Keywords

cerebral palsybalancemirror therapy

Outcome Measures

Primary Outcomes (6)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Study Arms (2)

the control group

NO INTERVENTION

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

the study group

EXPERIMENTAL

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

Other: MIRROR THERAPY

Interventions

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).

the study group

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Valley University, Faculty of Physical Therapy

Qina, Qena Governorate, 83523, Egypt

Location

Related Publications (12)

  • 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.

    PMID: 19454781BACKGROUND
  • 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.

    PMID: 29077129BACKGROUND
  • 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.

    PMID: 15754176BACKGROUND
  • 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.

    PMID: 26254950BACKGROUND
  • 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.

  • 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.

  • 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.

  • 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.

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

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Mirror Movement Therapy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesRehabilitationTherapeutics

Study Officials

  • Nehad A. Abo-zaid, PhD

    South Valley University, Faculty of Physical Therapy

    PRINCIPAL INVESTIGATOR
  • Mohammed E. Ali, PhD student

    South Valley University, Faculty of Physical Therapy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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).
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

January 4, 2020

First Posted

January 13, 2020

Study Start

December 1, 2019

Primary Completion

March 1, 2020

Study Completion

March 31, 2020

Last Updated

January 13, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations