CIMT and BIMT Affect Functional Outcome in CP

Cerebral Palsy, Congenital Clinical Trial

Official title:

Comparison of Constrained Induced Movement Therapy and Bimanual Intensive Movement Therapy on Functional Outcome of Hemiplegic Cerebral Palsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04211623
• Other study ID #: RiphahIUHumaile
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: July 31, 2019

Study information

• Verified date: December 2019
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this randomized controlled trial is to determine the effects of constraint induced movement therapy CIMT and BIM bimanual activities on functional outcome in hemiplegic CP. Two randomized groups of patients with CP are treated with constrained arm for three hours on affected side and bimanual activities on BIM group respectively. Both, male and female patients meeting the inclusion criteria will be included. Patients having concurrent malignancy, infection, trauma or any bony deformity will be excluded.

Description:

It is a Randomized control trial. Cerebral palsy children of age groups of 5 yrs to 12 years were included in the study with total sample size of thirty eight (38) with confidence interval of 95%. Simple random sampling was done by lottery method and data was collected from ALFARABI special school of education Islamabad. Two groups were formed and named as group A; CIMT with nineteen participants and group B, BIM bimanual training with nineteen participants respectively. The RCT compared the functional outcome of 3 hours constraining for 3 times a week for 6 weeks duration for CIMT group and five bimanual activities performed for three hours a day for bimanual group B and were assessed on the pretest and post test score evaluation of QUEST and JTHF test. All the participants were hemiplegic cp from both gender, fall on MAC system level II. Treatment for three hours was done on alternate days for 3 days a week. Five bimanual activites of holding a tray, cutting a fruit with knife, buttoning, cutting paper with scissor, and carry heavy objects with both hands are applied. Whereas the activities performed in CIMT are brushing teeth, holding spoon, fork combing hair and writing. Forty five children were screened before the evaluation and as a result 38 were enrolled in both groups having 19 in each group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: July 31, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

Inclusion Criteria:

• Patients with age group of 5-12 years. Patients with hemiplegic cerebral palsy of both genders. Patients who have active wrist extension, active PIP -MCP joint extension and active thumb extension.

Patients who have mild spasticity on spasticity rating scale of QUEST test Patients who fall on level II on MAC System are included Patients who has cognitive dysfunction ( screening by WISC Wechsler Intelligence test for children) all have score above 80.

Exclusion Criteria:

• Patients who can develop any sort of behavior problems Patients who does not co-operate with therapist in CIMT procedure Any structural deformity. Any surgical intervention that requires patient to be immobile.

Related Conditions & MeSH terms

• Cerebral Palsy
• Cerebral Palsy, Congenital

Intervention

Other:
• Constraint induced movement therapy
Constrained on more affected side for three hours. To minimize the learned non use in hemiplegic CIMT is applied and criteria of applying CIMT is; 10 degrees active wrist extension on the affected hand, 10 degrees active thumb abduction, 10 º active extension of any two digits on the side or hand which is limited due to damage. In order to gain the maximum good results from CIMT technique following points should also be considered attentively. Affected arm should move to 45 degrees shoulder flexion and abduction, and 90 degrees of elbow flexion and extension. Constrained with cotton sling. 3 to 5 upper limb functional activities like using fork or a spoon, combing hair brushing teeth writing dressing all activities are performed for 10 t0 15 minutes in period of three hours on alternate days in a week
• Bimanual activities
Bimanual activities of both hands are performed like Set of bimanual activities is used to assess the bimanual hand function. Five bimanual activities are performed such as carrying a tray, cutting a fruit with a knife, holding and cutting the paper with scissor, buttoning and Carrying heavy objects with both hands. Every activity was performed for 10 t0 15 minutes on alternate days for a period of 6 weeks session.

Locations

Country	Name	City	State
Pakistan	Riphah International University	Islamabad

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (12)

Charles J, Gordon AM. A critical review of constraint-induced movement therapy and forced use in children with hemiplegia. Neural Plast. 2005;12(2-3):245-61; discussion 263-72. Review. — View Citation

Charles J, Gordon AM. Development of hand-arm bimanual intensive training (HABIT) for improving bimanual coordination in children with hemiplegic cerebral palsy. Dev Med Child Neurol. 2006 Nov;48(11):931-6. Review. — View Citation

de Brito Brandão M, Mancini MC, Vaz DV, Pereira de Melo AP, Fonseca ST. Adapted version of constraint-induced movement therapy promotes functioning in children with cerebral palsy: a randomized controlled trial. Clin Rehabil. 2010 Jul;24(7):639-47. doi: 10.1177/0269215510367974. Epub 2010 Jun 8. — View Citation

Dickerson AE, Brown LE. Pediatric constraint-induced movement therapy in a young child with minimal active arm movement. Am J Occup Ther. 2007 Sep-Oct;61(5):563-73. — View Citation

Dong VA, Tung IH, Siu HW, Fong KN. Studies comparing the efficacy of constraint-induced movement therapy and bimanual training in children with unilateral cerebral palsy: a systematic review. Dev Neurorehabil. 2013;16(2):133-43. doi: 10.3109/17518423.2012.702136. Epub 2012 Sep 4. Review. — View Citation

Geerdink Y, Lindeboom R, de Wolf S, Steenbergen B, Geurts AC, Aarts P. Assessment of upper limb capacity in children with unilateral cerebral palsy: construct validity of a Rasch-reduced Modified House Classification. Dev Med Child Neurol. 2014 Jun;56(6):580-6. doi: 10.1111/dmcn.12395. Epub 2014 Feb 11. — View Citation

Gordon AM, Schneider JA, Chinnan A, Charles JR. Efficacy of a hand-arm bimanual intensive therapy (HABIT) in children with hemiplegic cerebral palsy: a randomized control trial. Dev Med Child Neurol. 2007 Nov;49(11):830-8. — View Citation

Obladen M. Lame from birth: early concepts of cerebral palsy. J Child Neurol. 2011 Feb;26(2):248-56. doi: 10.1177/0883073810383173. Epub 2010 Dec 30. — View Citation

Rosenbaum P, Stewart D. The World Health Organization International Classification of Functioning, Disability, and Health: a model to guide clinical thinking, practice and research in the field of cerebral palsy. Semin Pediatr Neurol. 2004 Mar;11(1):5-10. Review. — 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

Utley A, Steenbergen B, Sugden DA. The influence of object size on discrete bimanual co-ordination in children with hemiplegic cerebral palsy. Disabil Rehabil. 2004 May 20;26(10):603-13. — View Citation

Wittenberg GF, Schaechter JD. The neural basis of constraint-induced movement therapy. Curr Opin Neurol. 2009 Dec;22(6):582-8. doi: 10.1097/WCO.0b013e3283320229. Review. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of upper extremity skills test	Quality of upper extremity skills test or QOL quality of life. This scoring includes dissociated movements, grasps, weight bearing and protected extension. This scoring helps the therapist to determine which functional limitations needs to be addressed for better flexion extension abduction and other related movements to improve quality of life . It includes 36 items to be tested and thirty to forty minutes to apply and assess the test.	6 weeks
Primary	JEBSEN Hand Function Test	The JEBSEN Hand Function Test was designed to provide a comprehensive, objective test of hand function for actions of daily living. It has 7 items and takes approximately 15-45 minutes to administer. 7 items include: writing, turning over 3-by-5 inch cards, picking up small common objects, stacking checkers, simulated feeding, picking up large light objects and picking up large heavy objects. The results are calculated by timing the time taken to complete each task. The tests are always presented in the same order and are performed with the non-dominant hand first	6 weeks
Secondary	Manual ability classification	The Manual Ability Classification System (MACS) describes how children with (CP) use their hands to carry objects in daily routine. MAC describes 5 levels. These levels are based on the children's self-initiated ability to handle objects and their need for assistance or adaptation to perform manual activities in everyday life. The MACS also describe differences between adjacent levels to make it easier to determine which level best corresponds with the child's capability to handle objects. The objects are relevant and age-appropriate for the children, used when they perform tasks such as eating, dressing, playing, drawing or writing. Etc.	6 weeks