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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06021899
Other study ID # YIRS/007
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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