Spastic Hemiplegic Cerebral PalsyNCT03612128
The Effect of Mirror Therapy on Cerebral Re-organization, Functional Motor Skills, and Quality of Life in Hemiplegic Cerebral Palsy
A study testing intervention group in people with Spastic Hemiplegic Cerebral Palsy, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to investigate brain reorganization, functional motor development, level of daily living activity and quality of life of upper extremity mirror therapy in children with spastic hemiplegic cerebral palsy. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Spastic Hemiplegic Cerebral Palsy
- What is being tested?
- intervention group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Jan 2015to 13 Mar 2017
- 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 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Congenital spastic hemiplegic cerebral palsy,
- Between the ages of 4-18,
- Continuing physiotherapy and rehabilitation program throughout the study.
Who cannot join
- Upper extremity fracture or muscle-tendon and bone operation shortly before 6 months,
- Any pharmacologic agent that will inhibit spasticity within 6 months,
- Visual function disorder except eye fracture defect
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Upper Extremity Mirror Therapy on Cerebral Re-organization, Functional Motor Skills, Daily Life Activities and Health Related Quality of Life in Children With Spastic Hemiplegic Cerebral Palsy
The purpose of this study is to investigate brain reorganization, functional motor development, level of daily living activity and quality of life of upper extremity mirror therapy in children with spastic hemiplegic cerebral palsy. Several studies have reported increased use of the affected arm following rearrangement of cerebral re-organization with mirror therapy. The investigator's study is the first of its kind and was planned to evaluate the effectiveness of upper extremity mirror therapy in cerebral reorganization and functional motor skills in children with spastic hemiplegic cerebral palsy. Hypothesis of this study is that mirror therapy improves brain re-organisation, functional motor skills and daily living activities in unilateral spastic CP.
Read the detailed description
Cerebral palsy (CP) is the most common neurodisability in children. It has been defined as a disorder of movement and posture due to a defect or lesion of the immature brain and as a group of non-progressive, but often changing motor impairment syndromes secondary to lesions or anomalies of the brain arising in the early stages of development.
Characteristically, children with unilateral cerebral palsy (CP) have one well-functioning hand and one impaired hand.Common features of the hemiplegic hand are slowness, abnormal muscle tone, decreased strength, and coordination difficulties, which occur to a varying extent in children independently of age. Many children also have impaired sensibility and mirror movements. Perhaps most importantly, children with unilateral CP hav e varying degrees of limitation in their ability to handle objects in daily life. This limitation is most obvious insituations where two hands are needed. However, knowledge about bimanual ability in chil dren with unilateral CP and its development over time is scarce at present.
To improve upper extremity function in children with unilateral CP, the mirror therapy is a promising approach. Mirror therapy for the first time, Ramachandran et al. has described for the treatment of phantom pain in amputee. Also in unilateral spastic CP mirror therapy have indicated that visual illusion of functional limb provided by mirror can support healing. By means of visual feedback, modified vision and perception is stimulated plasticity the premotor cortex and developed re-organization. In the current studies, mirror therapy in hemiplegic patients, have been shown that improve the function and reduce the sensitivity of the hemi neglect. Gygax et al. have investigated the effects of mirror therapy on upper extremity function 10 children with unilateral spastic CP between 6-14 years. Consequently, the spontaneous use affected hand, the maximum grip force increase of 15% and is demonstrated that improve the upper extremity motor function.
- Conditions
- Spastic Hemiplegic Cerebral Palsy
- Being tested
- control group, intervention group
- Keywords
- cerebral palsy, mirror therapy, cerebral re-organization, upper extremity, daily life activities, functional motor capacity, motor functions
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
control groupOther
Also called traditional physiotherapy
Children continued their traditional physiotherapy including upper limb exercises in three times a week for 8 week.
intervention groupOther
Also called mirror therapy in addition to traditional physiotherapy
Participants allocated to the experimental group completed three times a week, 8-week mirror therapy in addition to traditional physiotherapy . This protocol consisted of mirror therapy with a mirror box.
| Study group | Role | What they receive |
|---|---|---|
| control group | Other | Children continued their traditional physiotherapy Receives: Other: control group |
| intervention group | Active comparator | We applied mirror therapy in addition to traditional physiotherapy Receives: Other: intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Magnetic Resonance Imaging (fMRI)
Brain reorganization was assessed by functional magnetic resonance imaging (fMRI).Being a non-invasive method, FMRI is nowadays the most common method used to map the neural activity of the human brain. fMRI is also used to describe patterns of cortical activation in children and adults with brain lesions
Measured: change from baseline brain reorganization at 8 weeks
Quality of upper extremity skills assessment (QUEST)
Quality of upper extremity skills assessment was be assessed by Quality of Upper Extremity Skills Test (QUEST). The test evaluates that handcraft and the quality of the movement in children with CP.This is an objective standardized measure evaluating the quality of upper extremity function in 4 domains: dissociated movement, grasp, protective extension, and weight bearing. Scores for the QUEST are calculated as percentages with a maximum score of 100.
Measured: change from baseline upper extremity skills at 8 weeks
Secondary outcomes (2)
Functional independence measure (WeeFIM)
The functional independence assessment was be assessed by Functional Independence Measure (WeeFIM). The Weefim was designed as a basic indicator of severity of disability and to determine the amount of assistance required by children to perform daily living activities on a consistent basisThe subsets are categorized as self-care (six items), sphincter control (two items),transfers (three items), locomotion (two items), communication (two items), and social cognition (three items). Each measurement item of the subsets is scored on a scale of 1- 7, where 1 indicates total assistance and 7 shows complete independence. The minimum total score is 18 (total dependence in all skills) and the maximum score is 126 (complete independence in all skills).
Measured: change from baseline functional independence at 8 weeks
Child Health Questionnaire Parent Form 50 Questions (CHQ-PF50)
Health related quality of life was evaluated by the Child Health Questionnaire Parent Form 50 Questions (CHQ-PF50). 50-item parent-completed CHQ (CHQ-PF50), which measures 11 domains of health. Physical domains include the following: physical functioning, role/social limitations as a result of physicalhealth, bodily pain/discomfort, and general health perception.
Psychosocial domains include the following: role/social limitations as a result of emotional-behavioral problems, self-esteem, mental health, general behavior, emotional impact on parent, and time impact on parents. A separate domain measures limitations in family activities. There is also a single-item measure of family cohesion. Scores for the domains and single item range from 0 to 100, with higher scores indicating better HRQL
Measured: change from baseline quality of life at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start12 Jan 2015
- Primary completion19 Dec 2016
- Study completion13 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Spastic Hemiplegic Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- In this type of controlled clinical trials, the same subjects are used as experimental and control groups, ie both the new treatment method and the classical method or the placebo method are applied to the same subjects. The efficacy is applied to the new treatment method and on the other hand the classical method is applied on the same subjects at different times and the results are compared.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duygu Korkem, Hacettepe University
- Investigators
- Duygu Korkem, PhD, Study director, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03612128
- Sponsor's protocol ID
- 7603
- Status last verified
- Aug 2018
- First submitted
- 27 Jul 2018
- Last updated
- 3 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fedrizzi E, Pagliano E, Andreucci E, Oleari G. Hand function in children with hemiplegic cerebral palsy: prospective follow-up and functional outcome in adolescence. Dev Med Child Neurol. 2003 Feb;45(2):85-91.
PubMed 12578233Siebes RC, Wijnroks L, Vermeer A. Qualitative analysis of therapeutic motor intervention programmes for children with cerebral palsy: an update. Dev Med Child Neurol. 2002 Sep;44(9):593-603. doi: 10.1017/s0012162201002638.
PubMed 12227614Odding E, Roebroeck ME, Stam HJ. The epidemiology of cerebral palsy: incidence, impairments and risk factors. Disabil Rehabil. 2006 Feb 28;28(4):183-91. doi: 10.1080/09638280500158422.
PubMed 16467053Skold A, Josephsson S, Eliasson AC. Performing bimanual activities: the experiences of young persons with hemiplegic cerebral palsy. Am J Occup Ther. 2004 Jul-Aug;58(4):416-25. doi: 10.5014/ajot.58.4.416.
PubMed 15315248Gygax MJ, Schneider P, Newman CJ. Mirror therapy in children with hemiplegia: a pilot study. Dev Med Child Neurol. 2011 May;53(5):473-6. doi: 10.1111/j.1469-8749.2011.03924.x. Epub 2011 Mar 17.
PubMed 21410693
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Upper Extremity Mirror Therapy on Cerebral Re-organization, Functional Motor Skills, Daily Life Activities and Health Related Quality of Life in Children With Spastic Hemiplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03612128
- Acronym / sponsor ID
- 7603
- Conditions
- Spastic Hemiplegic Cerebral Palsy
- Keywords
- cerebral palsy, mirror therapy, cerebral re-organization, upper extremity, daily life activities, functional motor capacity, motor functions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 12 Jan 2015 (actual)
- Primary completion
- 19 Dec 2016 (actual)
- Study completion
- 13 Mar 2017 (actual)
- First posted
- 2 Aug 2018 (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 purpose of this study is to investigate brain reorganization, functional motor development, level of daily living activity and quality of life of upper extremity mirror therapy in children with spastic hemiplegic cerebral palsy. Several studies have reported increased use of the affected arm following rearrangement of cerebral re-organization with mirror therapy. The investigator's study is the first of its kind and was planned to evaluate the effectiveness of upper extremity mirror therapy in cerebral reorganization and functional motor skills in children with spastic hemiplegic cerebral palsy. Hypothesis of this study is that mirror therapy improves brain re-organisation, functional motor skills and daily living activities in unilateral spastic CP.
Detailed description
Cerebral palsy (CP) is the most common neurodisability in children. It has been defined as a disorder of movement and posture due to a defect or lesion of the immature brain and as a group of non-progressive, but often changing motor impairment syndromes secondary to lesions or anomalies of the brain arising in the early stages of development.
Characteristically, children with unilateral cerebral palsy (CP) have one well-functioning hand and one impaired hand.Common features of the hemiplegic hand are slowness, abnormal muscle tone, decreased strength, and coordination difficulties, which occur to a varying extent in children independently of age. Many children also have impaired sensibility and mirror movements. Perhaps most importantly, children with unilateral CP hav e varying degrees of limitation in their ability to handle objects in daily life. This limitation is most obvious insituations where two hands are needed. However, knowledge about bimanual ability in chil dren with unilateral CP and its development over time is scarce at present.
To improve upper extremity function in children with unilateral CP, the mirror therapy is a promising approach. Mirror therapy for the first time, Ramachandran et al. has described for the treatment of phantom pain in amputee. Also in unilateral spastic CP mirror therapy have indicated that visual illusion of functional limb provided by mirror can support healing. By means of visual feedback, modified vision and perception is stimulated plasticity the premotor cortex and developed re-organization. In the current studies, mirror therapy in hemiplegic patients, have been shown that improve the function and reduce the sensitivity of the hemi neglect. Gygax et al. have investigated the effects of mirror therapy on upper extremity function 10 children with unilateral spastic CP between 6-14 years. Consequently, the spontaneous use affected hand, the maximum grip force increase of 15% and is demonstrated that improve the upper extremity motor function.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In this type of controlled clinical trials, the same subjects are used as experimental and control groups, ie both the new treatment method and the classical method or the placebo method are applied to the same subjects. The efficacy is applied to the new treatment method and on the other hand the classical method is applied on the same subjects at different times and the results are compared.
| Arm | Type | Receives |
|---|---|---|
| control group | Other | Other: control groupChildren continued their traditional physiotherapy |
| intervention group | Active comparator | Other: intervention groupWe applied mirror therapy in addition to traditional physiotherapy |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Congenital spastic hemiplegic cerebral palsy,
- Between the ages of 4-18,
- Continuing physiotherapy and rehabilitation program throughout the study.
Key exclusion criteria (3 listed)
- Upper extremity fracture or muscle-tendon and bone operation shortly before 6 months,
- Any pharmacologic agent that will inhibit spasticity within 6 months,
- Visual function disorder except eye fracture defect
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 |
|---|---|---|
| control groupAlso: traditional physiotherapyChildren continued their traditional physiotherapy including upper limb exercises in three times a week for 8 week. | Other | control group |
| intervention groupAlso: mirror therapy in addition to traditional physiotherapyParticipants allocated to the experimental group completed three times a week, 8-week mirror therapy in addition to traditional physiotherapy . This protocol consisted of mirror therapy with a mirror box. | Other | intervention group |
Primary outcome
Functional Magnetic Resonance Imaging (fMRI)
Time frame: change from baseline brain reorganization at 8 weeks
Brain reorganization was assessed by functional magnetic resonance imaging (fMRI).Being a non-invasive method, FMRI is nowadays the most common method used to map the neural activity of the human brain. fMRI is also used to describe patterns of cortical activation in children and adults with brain lesions
Quality of upper extremity skills assessment (QUEST)
Time frame: change from baseline upper extremity skills at 8 weeks
Quality of upper extremity skills assessment was be assessed by Quality of Upper Extremity Skills Test (QUEST). The test evaluates that handcraft and the quality of the movement in children with CP.This is an objective standardized measure evaluating the quality of upper extremity function in 4 domains: dissociated movement, grasp, protective extension, and weight bearing. Scores for the QUEST are calculated as percentages with a maximum score of 100.
2 secondary outcomes
Functional independence measure (WeeFIM)
Time frame: change from baseline functional independence at 8 weeks
Child Health Questionnaire Parent Form 50 Questions (CHQ-PF50)
Time frame: change from baseline quality of life at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
- Background: PubMed 12578233Fedrizzi E, Pagliano E, Andreucci E, Oleari G. Hand function in children with hemiplegic cerebral palsy: prospective follow-up and functional outcome in adolescence. Dev Med Child Neurol. 2003 Feb;45(2):85-91.
- Background: PubMed 12227614Siebes RC, Wijnroks L, Vermeer A. Qualitative analysis of therapeutic motor intervention programmes for children with cerebral palsy: an update. Dev Med Child Neurol. 2002 Sep;44(9):593-603. doi: 10.1017/s0012162201002638.
- Background: PubMed 16467053Odding E, Roebroeck ME, Stam HJ. The epidemiology of cerebral palsy: incidence, impairments and risk factors. Disabil Rehabil. 2006 Feb 28;28(4):183-91. doi: 10.1080/09638280500158422.
- Background: PubMed 15315248Skold A, Josephsson S, Eliasson AC. Performing bimanual activities: the experiences of young persons with hemiplegic cerebral palsy. Am J Occup Ther. 2004 Jul-Aug;58(4):416-25. doi: 10.5014/ajot.58.4.416.
- Background: PubMed 21410693Gygax MJ, Schneider P, Newman CJ. Mirror therapy in children with hemiplegia: a pilot study. Dev Med Child Neurol. 2011 May;53(5):473-6. doi: 10.1111/j.1469-8749.2011.03924.x. Epub 2011 Mar 17.
- 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.
Duygu Korkem, PhD study director
Uskudar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intervention group in people with Spastic Hemiplegic Cerebral Palsy, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 3 Aug 2018. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Functional Magnetic Resonance Imaging (fMRI) (time frame: change from baseline brain reorganization at 8 weeks). The study lists 2 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 NCT03612128, which also lists 5 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 3 Aug 2018.