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Individualized Comprehensive Home-Centred Activity Based Therapy for Children With Diplegic Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT02412007
Recruitment Status : Completed
First Posted : April 8, 2015
Last Update Posted : October 21, 2019
Sponsor:
Information provided by (Responsible Party):
DR J N GOSWAMI, Postgraduate Institute of Medical Education and Research

Brief Summary:
Activity based therapy is gaining interest for rehabilitation of children with cerebral palsy (CP). A home-based comprehensive programme structured on the principles of activity based therapy seems to hold promise in the field of rehabilitation of children with diplegic CP.This may reduce morbidity as well as promote better quality of life in these children . In this backdrop our study has been planned with an aim to evaluate the efficacy of a comprehensive home-centred activity based programme for children with diplegic CP.

Condition or disease Intervention/treatment Phase
Diplegic Cerebral Palsy Other: Individualized comprehensive home centred activity based programme Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Prospective Study (RCT) to Evaluate the Efficacy of an Individualized Comprehensive Home-Centred Activity Based Therapy for Children With Diplegic Cerebral Palsy
Study Start Date : October 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : June 2016

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Arm Intervention/treatment
Experimental: Group A

Individualized comprehensive home centred activity based programme. Simple activities would be advised on the basis of child's individual characteristics and parental expectations. These would include but would not be limited to (a) Standing up from squatting position to catch an object of interest.

(b) Squatting from standing position to pick an object of interest. (c) Walking to reach an object of interest. (d) Climbing up steps to get an object of interest. (e) Climbing down steps to keep the above object of interest. (f) Cycling (g) Kicking a football (h) Dancing

Other: Individualized comprehensive home centred activity based programme

Simple activities would be advised on the basis of child's individual characteristics and parental expectations. These would include but would not be limited to

  1. Standing up from squatting position to catch an object of interest.
  2. Squatting from standing position to pick an object of interest.
  3. Walking to reach an object of interest.
  4. Climbing up steps to get an object of interest.
  5. Climbing down steps to keep the above object of interest.
  6. Cycling
  7. Kicking a football
  8. Dancing
Other Name: Activity Based Therapy

Active Comparator: Group B

Conventional Physiotherapy Conventional physiotherapy would include and would not be limited to

  1. Passive stretching exercises for spasticity reduction
  2. Gait exercises
  3. Walking on treadmill
  4. Lower limb strengthening exercises
  5. Exercises for balance improvenet
Other: Individualized comprehensive home centred activity based programme

Simple activities would be advised on the basis of child's individual characteristics and parental expectations. These would include but would not be limited to

  1. Standing up from squatting position to catch an object of interest.
  2. Squatting from standing position to pick an object of interest.
  3. Walking to reach an object of interest.
  4. Climbing up steps to get an object of interest.
  5. Climbing down steps to keep the above object of interest.
  6. Cycling
  7. Kicking a football
  8. Dancing
Other Name: Activity Based Therapy




Primary Outcome Measures :
  1. Change in distance covered as measured by 6 minute walk test (in metres) [ Time Frame: six months ]
    The test is performed on a quadrangular ,plain floor which has a marked rectangular area,the perimeter of which is thirty four metres.Subject and his/her attendant is initially given demonstration and then he/she is made to walk along the marked surface continuously for six minutes and the same is videographed..The distance covered is measured and recorded.


Secondary Outcome Measures :
  1. Change in Modified Ashworth Scale Score [ Time Frame: 3 months; 6 months ]
  2. Change in Modified tardieu Scale Score [ Time Frame: 3 months; 6 months ]
  3. Change in 10metres fast walk score [ Time Frame: baseline, 3 months; 6 months ]
    Child is made to walk 10 metres on a plain marked surface and the time taken for the same is recorded.The same is videographed.This is done at enrollment and 3 months and 6 months after enrolment

  4. Change in Gross Motor Function Measure 88 D & E Scores (GMFM-88 D & E) [ Time Frame: 3 months; 6 months ]
  5. Change in Cerebral Palsy Quality of Life (Primary Care Giver ) Score (CPQoL) [ Time Frame: 3 months; 6 months ]


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Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02412007


Locations
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India
Postgraduate Institute of Medical Education and Research
Chandigarh, India, 160012
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
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Study Director: Prof Pratibha Singhi, MD Post Graduate Institute of Medical Education and Research,Chandigarh,India
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Responsible Party: DR J N GOSWAMI, Senior Resident, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT02412007    
Other Study ID Numbers: Activity Based Therapy in CP
First Posted: April 8, 2015    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019
Keywords provided by DR J N GOSWAMI, Postgraduate Institute of Medical Education and Research:
spastic diplegia;cerebral palsy;activity based therapy
Additional relevant MeSH terms:
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Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases