Hemiplegic Cerebral Palsy Clinical Trial
— CIMTOfficial title:
Comparison of Constraint-induced Movement Therapy and Its Modified Form on Upper Motor Function Outcomes and Psychosocial Impact in Hemiplegic Cerebral Palsy.
Verified date | August 2019 |
Source | Riphah International University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this research is to compare the effect of classic constraint-induced movement therapy and its modified form on upper extremity motor function outcomes and psychosocial impact in hemiplegic cerebral palsy. Randomized controlled trials with 2-3 weeks follow-up. The sample size is 40. The subjects are divided in two groups, 20 subjects in classical CIMT group and 20 in modified CIMT group. Study duration is of 6 months. Sampling technique applied will be purposive non probability sampling technique. Only 4-12 years individual with hemiplegic cerebral palsy are included. Tools used in the study are Box and Block test, Cerebral palsy (quality of life), Kid Screen 27 and QUEST (quality of upper extremity skill test). Data will be analyzed through SPSS 21.
Status | Completed |
Enrollment | 40 |
Est. completion date | March 1, 2019 |
Est. primary completion date | February 10, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years to 12 Years |
Eligibility |
Inclusion Criteria: - 4 to 12 years CP with unilateral, bilateral or severely asymmetrical impairment Manual Ability Classification System(MACS) I, II or III - Wrist extension capacity at least 20°; fingers with 10° of complete flexion - Children able to follow Command Exclusion Criteria: - Children also having disabilities other than Cerebral palsy - Contractures that significantly limit functional arm use. - Children with MR. |
Country | Name | City | State |
---|---|---|---|
Pakistan | Riphah International University | Islamabad | Federal |
Lead Sponsor | Collaborator |
---|---|
Riphah International University |
Pakistan,
Aarts PB, Jongerius PH, Geerdink YA, van Limbeek J, Geurts AC. Effectiveness of modified constraint-induced movement therapy in children with unilateral spastic cerebral palsy: a randomized controlled trial. Neurorehabil Neural Repair. 2010 Jul-Aug;24(6):509-18. doi: 10.1177/1545968309359767. Epub 2010 Apr 27. — View Citation
Al-Oraibi S, Eliasson AC. Implementation of constraint-induced movement therapy for young children with unilateral cerebral palsy in Jordan: a home-based model. Disabil Rehabil. 2011;33(21-22):2006-12. doi: 10.3109/09638288.2011.555594. Epub 2011 Feb 18. — View Citation
de Brito Brandão M, Gordon AM, Mancini MC. Functional impact of constraint therapy and bimanual training in children with cerebral palsy: a randomized controlled trial. Am J Occup Ther. 2012 Nov-Dec;66(6):672-81. doi: 10.5014/ajot.2012.004622. — View Citation
Deppe W, Thuemmler K, Fleischer J, Berger C, Meyer S, Wiedemann B. Modified constraint-induced movement therapy versus intensive bimanual training for children with hemiplegia - a randomized controlled trial. Clin Rehabil. 2013 Oct;27(10):909-20. doi: 10.1177/0269215513483764. Epub 2013 Jul 1. — View Citation
Eliasson AC, Krumlinde-sundholm L, Shaw K, Wang C. Effects of constraint-induced movement therapy in young children with hemiplegic cerebral palsy: an adapted model. Dev Med Child Neurol. 2005 Apr;47(4):266-75. — View Citation
Facchin P, Rosa-Rizzotto M, Visonà Dalla Pozza L, Turconi AC, Pagliano E, Signorini S, Tornetta L, Trabacca A, Fedrizzi E; GIPCI Study Group. Multisite trial comparing the efficacy of constraint-induced movement therapy with that of bimanual intensive training in children with hemiplegic cerebral palsy: postintervention results. Am J Phys Med Rehabil. 2011 Jul;90(7):539-53. doi: 10.1097/PHM.0b013e3182247076. — View Citation
Gordon AM, Hung YC, Brandao M, Ferre CL, Kuo HC, Friel K, Petra E, Chinnan A, Charles JR. Bimanual training and constraint-induced movement therapy in children with hemiplegic cerebral palsy: a randomized trial. Neurorehabil Neural Repair. 2011 Oct;25(8):692-702. doi: 10.1177/1545968311402508. Epub 2011 Jun 23. — View Citation
Himmelmann K, Beckung E, Hagberg G, Uvebrant P. Gross and fine motor function and accompanying impairments in cerebral palsy. Dev Med Child Neurol. 2006 Jun;48(6):417-23. — View Citation
Hoare B, Imms C, Carey L, Wasiak J. Constraint-induced movement therapy in the treatment of the upper limb in children with hemiplegic cerebral palsy: a Cochrane systematic review. Clin Rehabil. 2007 Aug;21(8):675-85. Review. — View Citation
Maenner MJ, Blumberg SJ, Kogan MD, Christensen D, Yeargin-Allsopp M, Schieve LA. Prevalence of cerebral palsy and intellectual disability among children identified in two U.S. National Surveys, 2011-2013. Ann Epidemiol. 2016 Mar;26(3):222-6. doi: 10.1016/j.annepidem.2016.01.001. Epub 2016 Jan 12. — View Citation
Novak I, McIntyre S, Morgan C, Campbell L, Dark L, Morton N, Stumbles E, Wilson SA, Goldsmith S. A systematic review of interventions for children with cerebral palsy: state of the evidence. Dev Med Child Neurol. 2013 Oct;55(10):885-910. doi: 10.1111/dmcn.12246. Epub 2013 Aug 21. Review. — View Citation
Reddihough D. Cerebral palsy in childhood. Aust Fam Physician. 2011 Apr;40(4):192-6. — View Citation
Sakzewski L, Carlon S, Shields N, Ziviani J, Ware RS, Boyd RN. Impact of intensive upper limb rehabilitation on quality of life: a randomized trial in children with unilateral cerebral palsy. Dev Med Child Neurol. 2012 May;54(5):415-23. doi: 10.1111/j.1469-8749.2012.04272.x. Epub 2012 Mar 17. — View Citation
Sakzewski L, Ziviani J, Boyd R. Systematic review and meta-analysis of therapeutic management of upper-limb dysfunction in children with congenital hemiplegia. Pediatrics. 2009 Jun;123(6):e1111-22. doi: 10.1542/peds.2008-3335. Epub 2009 May 18. Review. — View Citation
Tinderholt Myrhaug H, Østensjø S, Larun L, Odgaard-Jensen J, Jahnsen R. Intensive training of motor function and functional skills among young children with cerebral palsy: a systematic review and meta-analysis. BMC Pediatr. 2014 Dec 5;14:292. doi: 10.1186/s12887-014-0292-5. Review. — View Citation
Winter S, Autry A, Boyle C, Yeargin-Allsopp M. Trends in the prevalence of cerebral palsy in a population-based study. Pediatrics. 2002 Dec;110(6):1220-5. — View Citation
* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline [Box And Block Test (BBT)] at 3rd week | The Box and Blocks Test (BBT) is a functional test used in upper limb rehabilitation.The test is used to measure the gross manual dexterity of a patient.The test consists of a box with a partition in the middle. Blocks are placed at one side of the partition. The box is placed at a table. The test subject is seated, facing towards the box. During the tests the test subject is given 60 seconds to move as many blocks as possible from one side to the other, by using only his tested hand. The number of displaced blocks is a measure of the gross manual dexterity. A higher number of displaced blocks indicates a better gross dexterity. | 3rd week | |
Secondary | Change from Baseline [Quality Of Upper Extremity Skill Test (QUEST)] at 3rd week | The Quality of Upper Extremity Skills Test is an outcome measure designed to evaluate movement patterns and hand function in children with cerebral palsy. The QUEST is both reliable and valid. The purpose of the QUEST is to evaluate quality of upper extremity function in four domains: dissociated movement, grasp, protective extension, and weight bearing. 36 items assessing dissociated movements, grasp, protective extension, and weight bearing. | 3 weeks. | |
Secondary | Change from Baseline [Kid Screen 27] at 3rd week | The KIDSCREEN-27 was developed as a shorter version of the KIDSCREEN-52 with a minimum of information loss and with good psychometric properties. The KIDSCREEN-27 with five dimensions resulted. All five dimensions are Rasch scales: Physical Well-Being (5 items), Psychological Well-Being (7 items), Autonomy & Parents (7 items), Peers & Social Support (4 items), and School Environment (4 items). | 3 weeks. | |
Secondary | Change from Baseline [Cerebral Palsy Quality of Life CP(QOL)] at 3rd week | The Cerebral Palsy Quality of Life for Children (CP QOL-Child) is the first health condition-specific questionnaire designed for measuring QOL in children with cerebral palsy (CP) aged 4-12 years. CP QOL Questionnaires measure include : Social wellbeing & acceptance, Feelings about functioning, Participation & physical health, Emotional wellbeing & self-esteem, Access to services, Pain & impact of disability, Family health. | 3 weeks. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04635930 -
Taping and Traditional Exercises in Upper Limb Function in Hemiplegic
|
N/A | |
Terminated |
NCT03811275 -
Task or Virtual Reality Intervention for Improving UE Function
|
N/A | |
Completed |
NCT05068596 -
Effect of Loaded Functional Training on Hemiplegic Cerebral Palsy
|
N/A | |
Completed |
NCT03626077 -
Biofeedback Training and Physical Therapy Program Improves Visual-motor Integration in Children With Cerebral Palsy
|
N/A | |
Terminated |
NCT04009031 -
Video Game for Home-based Rehabilitation for Children With Hemiplegia
|
N/A | |
Completed |
NCT01973426 -
Evaluating Human-Machine Interfaces in a Robotic Thumb Orthosis
|
||
Recruiting |
NCT03361930 -
Changes in Muscle Activity of Children With Spastic Unilat Cerebral Palsy Using 2 Types of Ankle-foot Orthoses to Walk
|
N/A | |
Completed |
NCT05062122 -
The Effects of Vibration and Kinesiology Tape Applications in Children With Hemiplegic Cerebral Palsy
|
||
Not yet recruiting |
NCT04177186 -
Strength Training in Children With Spastic Diplegic and Hemiplegic Cerebral Palsy Receiving Botulinum Toxin
|
N/A | |
Completed |
NCT06021899 -
Effects of Classic and Modified CIMT on Quality of Life of Children With Hemiplegic CP
|
N/A | |
Recruiting |
NCT05011201 -
Dual Joint Visual Feedback Gait Retraining in Pediatric Hemiplegic Cerebral Palsy
|
N/A | |
Recruiting |
NCT05559320 -
Use of Joystick-operated Ride-on-toys to Improve Affected Arm Use and Function in Children With Hemiplegic Cerebral Palsy
|
N/A | |
Recruiting |
NCT06040619 -
Implementation of Therapy Together
|
N/A | |
Completed |
NCT06330831 -
Intensive Group Based CIMT for Young Children
|
N/A | |
Recruiting |
NCT06001983 -
Effect of Imaginary Resisted Therapy Versus Physical Resisted Therapy on Hemiplegic Cerebral Palsy
|
N/A | |
Recruiting |
NCT05931640 -
Effects of Plyometric Training Versus Virtual Reality Among Hemiplegic Cerebral Palsy
|
N/A | |
Completed |
NCT04894812 -
Vestibular and Motor Functions in Children With Hemiplegic Cerebral Palsy
|
N/A | |
Completed |
NCT05396053 -
Mirror Therapy Versus CIMT on Hand Function in Cerebral Palsy
|
N/A | |
Completed |
NCT05380011 -
Bimanual Task Training and Constraint-Induced Movement Therapy in Hemiplegic Cerebral Palsy Children
|
N/A | |
Completed |
NCT05490758 -
Sensorimotor Training and Constraint Induced Movement Therapy on Upper Extremity Function in Children With Hemiplegic CP
|
N/A |