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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02412007 |
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Date of registration:
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03/04/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Individualized Comprehensive Home-Centred Activity Based Therapy for Children With Diplegic Cerebral Palsy
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Scientific title:
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A Prospective Study (RCT) to Evaluate the Efficacy of an Individualized Comprehensive Home-Centred Activity Based Therapy for Children With Diplegic Cerebral Palsy |
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Date of first enrolment:
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October 2014 |
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Target sample size:
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59 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02412007 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Single (Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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India
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Contacts
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Name:
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Prof Pratibha Singhi, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Post Graduate Institute of Medical Education and Research,Chandigarh,India |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Children of either sex aged 5 to 12 years clinically diagnosed to have spastic
diplegic cerebral palsy .
2. GMFCS either II or III
3. Minimum visual acuity of 6/60
4. Ability to follow simple single step commands
5. Either parent should be willing and capable of following instructions and maintaining
activity log.
Exclusion Criteria:
1. Children with fixed contractures and deformities in lower limbs affecting stance and
gait.
2. Children who have received botulinum toxin injection or undergone orthopaedic
corrective surgery in the past one year.
3. Children with concomitant chronic systemic illnesses that can interfere with execution
of physiotherapy or activity based therapy.
4. Children with any acute illness.
Age minimum:
5 Years
Age maximum:
12 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Diplegic Cerebral Palsy
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Intervention(s)
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Other: Individualized comprehensive home centred activity based programme
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Primary Outcome(s)
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Change in distance covered as measured by 6 minute walk test (in metres)
[Time Frame: six months]
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Secondary Outcome(s)
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Change in 10metres fast walk score
[Time Frame: baseline, 3 months; 6 months]
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Change in Modified Ashworth Scale Score
[Time Frame: 3 months; 6 months]
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Change in Modified tardieu Scale Score
[Time Frame: 3 months; 6 months]
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Change in Gross Motor Function Measure 88 D & E Scores (GMFM-88 D & E)
[Time Frame: 3 months; 6 months]
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Change in Cerebral Palsy Quality of Life (Primary Care Giver ) Score (CPQoL)
[Time Frame: 3 months; 6 months]
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Secondary ID(s)
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Activity Based Therapy in CP
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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