The Effect of Mirror Therapy on Cerebral Re-organization, Functional Motor Skills, and Quality of Life in Hemiplegic Cerebral Palsy
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| ClinicalTrials.gov Identifier: NCT03612128 |
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Recruitment Status :
Completed
First Posted : August 2, 2018
Last Update Posted : August 3, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Spastic Hemiplegic Cerebral Palsy | Other: control group Other: intervention group | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 10 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention 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) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | January 12, 2015 |
| Actual Primary Completion Date : | December 19, 2016 |
| Actual Study Completion Date : | March 13, 2017 |
| Arm | Intervention/treatment |
|---|---|
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control group
Children continued their traditional physiotherapy
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Other: control group
Children continued their traditional physiotherapy including upper limb exercises in three times a week for 8 week.
Other Name: traditional physiotherapy |
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Active Comparator: intervention group
We applied mirror therapy in addition to traditional physiotherapy
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Other: intervention group
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.
Other Name: mirror therapy in addition to traditional physiotherapy |
- 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.
- Functional independence measure (WeeFIM) [ Time Frame: change from baseline functional independence at 8 weeks ]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).
- Child Health Questionnaire Parent Form 50 Questions (CHQ-PF50) [ Time Frame: change from baseline quality of life at 8 weeks ]
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
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| Ages Eligible for Study: | 4 Years to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Congenital spastic hemiplegic cerebral palsy,
- Between the ages of 4-18,
- Continuing physiotherapy and rehabilitation program throughout the study.
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03612128
| Turkey | |
| Hacettepe University | |
| Ankara, Turkey, 06100 | |
| Study Director: | Duygu Korkem, PhD | Uskudar University |
| Responsible Party: | Duygu Korkem, Researcher, Hacettepe University |
| ClinicalTrials.gov Identifier: | NCT03612128 |
| Other Study ID Numbers: |
7603 |
| First Posted: | August 2, 2018 Key Record Dates |
| Last Update Posted: | August 3, 2018 |
| Last Verified: | August 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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cerebral palsy mirror therapy cerebral re-organization upper extremity |
daily life activities functional motor capacity motor functions |
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Muscle Spasticity Paralysis Cerebral Palsy Neurologic Manifestations Nervous System Diseases Brain Damage, Chronic |
Brain Diseases Central Nervous System Diseases Muscular Diseases Musculoskeletal Diseases Muscle Hypertonia Neuromuscular Manifestations |