Effects of Classic and Modified CIMT on Quality of Life of Children With Hemiplegic CP

Hemiplegic Cerebral Palsy Clinical Trial

— CIMT  

Official title:

Effects of Classic Constraint Induced Movement Therapy and Its Modified Form on Quality of Life of Children With Hemiplegic Cerebral Palsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06021899
• Other study ID #: YIRS/007
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: January 1, 2019

Study information

• Verified date: August 2023
• Source: Health Education Research Foundation (HERF)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research is to see the effect of classic constraint-induced movement therapy and its modified form on quality of life of children with 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 Cerebral palsy (quality of life) and Kid Screen 27.

Description:

Both CCIMT and MCIMT are effective treatments to improve quality of life of children with CP. However conflicting evidence is present on which one of these is more effective and no final conclusion can be made to date. This study intends to add to the literature and contribute in reaching final conclusion about the superiority of either intervention. The purpose of this study was to see the psychosocial effect (quality of life) of CIMT and its modified form on HCP

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 1, 2019
• Est. primary completion date: December 30, 2018
• 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

Related Conditions & MeSH terms

• Cerebral Palsy
• Hemiplegic Cerebral Palsy

Intervention

Other:
• modified constraint induced movement therapy
Modified CIMT protocol that was based on suggestions made by Dromerick, Edwards, and Hahn (2000) . Modifications were reductions in the duration of mitt wear and massed practice compared with the traditional protocol

Locations

Country	Name	City	State
Pakistan	Yusra Institute of Rehablitation Science	Islamabad

Sponsors (1)

Lead Sponsor	Collaborator
Health Education Research Foundation (HERF)

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebral Palsy Quality of Life CP(QOL)	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.
Secondary	Kid Screen 27	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