NCT06021899

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

August 26, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 1, 2023

Completed
Last Updated

September 1, 2023

Status Verified

August 1, 2023

Enrollment Period

3 months

First QC Date

August 26, 2023

Last Update Submit

August 26, 2023

Conditions

Keywords

Constraint induced movement therapyCerebral palsyCPQOL

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Kid Screen 27

    3 weeks

Study Arms (2)

Classic CIMT group

ACTIVE COMPARATOR

Total session of 6 hours a day, 5 days per week for 3 weeks to Classic CIMT groups will be given.

Other: modified constraint induced movement therapy

mCIMT group

EXPERIMENTAL

Session of 6 hours a day, 5 session per week for first 2 weeks (CIMT), session of 2 hours a day, 5 days per week for last 1 week (BIT) to modified CIMT group will be given.

Other: modified constraint induced movement therapy

Interventions

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

Also known as: classic constaint induced movement therapy
Classic CIMT groupmCIMT group

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Children also having disabilities other than Cerebral palsy Contractures that significantly limit functional arm use. Children with MR

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yusra Institute of Rehablitation Science

Islamabad, 45400, Pakistan

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Saad Tariq, master

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mamoona Tasleem Afzal

Study Record Dates

First Submitted

August 26, 2023

First Posted

September 1, 2023

Study Start

October 1, 2018

Primary Completion

December 30, 2018

Study Completion

January 1, 2019

Last Updated

September 1, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations