HEMIPLEGIC CEREBRAL PALSYNCT04227262
Efficacy of Lower Extremity Mirror Therapy on Balance in Children With Hemiplegic Cerebral Palsy
A study testing MIRROR THERAPY in people with HEMIPLEGIC CEREBRAL PALSY, run by South Valley University at 1 site in Egypt.
Trial summary
The study will be conducted to assess the efficacy of mirror therapy on balance in children with hemiplegic cerebral palsy. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- HEMIPLEGIC CEREBRAL PALSY
- What is being tested?
- MIRROR THERAPY
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2019to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
South Valley University, Faculty of Physical Therapy
Qina, Qena Governorate, 83523
About this study
Official title: EFFICACY OF LOWER EXTREMITY MIRROR THERAPY ON BALANCE IN CHILDREN WITH HEMIPLEGIC CEREBRAL PALSY: A Randomized Controlled Trail
The study will be conducted to assess the efficacy of mirror therapy on balance in children with hemiplegic cerebral palsy.
Read the 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.
- Conditions
- HEMIPLEGIC CEREBRAL PALSY
- Being tested
- MIRROR THERAPY
- Keywords
- cerebral palsy, balance, mirror therapy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIRROR THERAPYOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: MIRROR THERAPY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antro-posterior stability index
the ability of child to maintain his balance from forward to backward direction
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Mediolateral Stability Index will be assessed at day 90.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start1 Dec 2019
- Primary completion1 Mar 2020 (estimated)
- Study completion31 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for HEMIPLEGIC CEREBRAL PALSYStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed E. Ali, Ph. D Candidate., South Valley University
- Investigators
- Nehad A. Abo-zaid, PhD, Principal investigator, South Valley University, Faculty of Physical TherapyMohammed E. Ali, PhD student, Principal investigator, South Valley University, Faculty of Physical Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04227262
- Sponsor's protocol ID
- P.T.REC/012/002575
- Status last verified
- Jan 2020
- First submitted
- 4 Jan 2020
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19454781Zeng 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.
PubMed 29077129Garry 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.
PubMed 15754176McInnes 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.
PubMed 26254950Kenis-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.
PubMed 27313338El-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.
PubMed 24032716Altschuler 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.
PubMed 18335358Funase 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.
PubMed 17481817Cattaneo L, Rizzolatti G. The mirror neuron system. Arch Neurol. 2009 May;66(5):557-60. doi: 10.1001/archneurol.2009.41.
PubMed 19433654Summers 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.
PubMed 17134723Sutbeyaz 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.
PubMed 17466722Saghaei 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.
PubMed 15535880
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFICACY OF LOWER EXTREMITY MIRROR THERAPY ON BALANCE IN CHILDREN WITH HEMIPLEGIC CEREBRAL PALSY: A Randomized Controlled Trail
- ClinicalTrials.gov ID
- NCT04227262
- Acronym / sponsor ID
- P.T.REC/012/002575
- Conditions
- HEMIPLEGIC CEREBRAL PALSY
- Keywords
- cerebral palsy, balance, mirror therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (actual)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Mar 2020 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 13 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| the control group | No intervention | –Group (a) control group received traditional physical therapy program. |
| the study group | Experimental | Other: MIRROR THERAPYgroup (b) study group received the same traditional physical therapy program in addition to mirror therapy three times / weak for three successful months. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MIRROR THERAPYThe 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). | Other | the study group |
Primary outcome
Antro-posterior stability index
Time frame: Antro-posterior stability index will be assessed at day 0.
the ability of child to maintain his balance from forward to backward direction
Antro-posterior stability index
Time frame: Antro-posterior stability index will be assessed at day 90.
the ability of child to maintain his balance from forward to backward direction
Over All Stability Index
Time frame: Over All Stability Index will be assessed at day 0.
the ability of child to maintain his balance in all directions
Over All Stability Index
Time frame: Over All Stability Index will be assessed at day 90.
the ability of child to maintain his balance in all directions
Mediolateral Stability Index
Time frame: Mediolateral Stability Index will be assessed at day 0.
the ability of child to maintain his balance from side to side directions
Mediolateral Stability Index
Time frame: Mediolateral Stability Index will be assessed at day 90.
the ability of child to maintain his balance from side to side directions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Background: PubMed 19454781Gstottner 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.
- Background: PubMed 29077129Zeng 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.
- Background: PubMed 15754176Garry 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.
- Background: PubMed 26254950McInnes 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 publication: PubMed 27313338Kenis-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 publication: PubMed 24032716El-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 publication: PubMed 18335358Altschuler 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 publication: PubMed 17481817Funase 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 publication: PubMed 19433654Cattaneo L, Rizzolatti G. The mirror neuron system. Arch Neurol. 2009 May;66(5):557-60. doi: 10.1001/archneurol.2009.41.
- Results publication: PubMed 17134723Summers 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 publication: PubMed 17466722Sutbeyaz 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 publication: PubMed 15535880Saghaei 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nehad A. Abo-zaid, PhD principal investigator
South Valley University, Faculty of Physical Therapy
Mohammed E. Ali, PhD student principal investigator
South Valley University, Faculty of Physical Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MIRROR THERAPY in people with HEMIPLEGIC CEREBRAL PALSY, run by South Valley University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antro-posterior stability index (time frame: Antro-posterior stability index will be assessed at day 0.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04227262, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.