Individualized Comprehensive Home-Centred Activity Based Therapy for Children With Diplegic Cerebral Palsy
Condition: Diplegic Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

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.
    

Detailed description: 
      Study settings:

      This study will be conducted on children enrolled in the Outpatient Clinic of Department of
      Pediatrics, Post Graduate Institute of Medical Education and Research, Chandigarh and the
      associated Outpatient Department of PRAYAAS (A project of Indian Council for Child Welfare)
      located at Dakshin Marg, Sector 38 B, Chandigarh which is a rehabilitation centre for
      children with cerebral palsy where the neurology unit of the department provides outreach
      services.

      Study Period:

      Oct 2014 to Dec 2015

      Study population:

      Consecutive children between 5 to 12 yrs age diagnosed as spastic diplegic cerebral palsy (as
      per the standard definition) brought to Outpatient Clinic of Department of Pediatrics, Post
      Graduate Institute of Medical Education and Research, Chandigarh and the associated
      Outpatient Department of PRAYAAS located at Dakshin Marg, Sector 38 B, Chandigarh.

      Sample Size:

      Keeping α=0.05.Power=80% Assumption: The intervention will result in 60metres change in
      distance covered.

      S.D. from previous study for (Gross Motor Function Classification System)GMFCS II =77 Hence,
      we would need 27 children in each group. Assuming a loss of follow-up of 5 patients, targeted
      sample size is 59.Therefore we would require 30 patients per group .

      Study design:

      Endpoint: Efficacy, Feasibility Intervention model: Parallel group assignment Primary
      Purpose: Physiotherapy Masking: Intervention - Open label Outcome assessment- Blinded
      Assessment of Data- Blinded

      Eligibility All children aged 5 to 12 years diagnosed with spastic diplegic cerebral palsy
      will be eligible for enrolment in the study. For the study, spastic diplegia would include
      those who have bilateral motor impairment affecting both lower extremities more than the
      upper extremities with objective clinical signs of both hyperreflexia and spasticity.

      Primary Outcome variables At six months Change in distance covered as measured by 6 minute
      walk test (in metres)

      Secondary Outcome variables:

      At three months and six months

        1. Change in Modified Ashworth Scale Scores

        2. Change in Modified Tardieu Scale Scores

        3. Change in 10metre fast walk score (in seconds)

        4. Change in GMFM D & E Scores.

        5. Change in Cerebral Palsy Quality of Life(CPQoL) (Primary Caregiver) Scores At three
           months Change in distance covered as measured by 6 minute walk test (in metres)

      Methodology:

      Patient flow Consecutive children of both sexes between 5-12 years with a clinical diagnosis
      of spastic cerebral palsy will be examined by the investigator and those meeting the
      inclusion criteria would be enrolled in the study.An informed consent would be taken from the
      parents or guardian prior to enrollment in the study. Clinical and demographic data will be
      recorded on a structured Performa for each child including age, sex, weight, detailed
      antenatal and birth history, complications during prenatal and neonatal period, detailed
      developmental history, and family history of any neurological conditions and presence of any
      known comorbidity of cerebral palsy.

      Randomization Children would be randomized into two groups by using randomization table. They
      would be classified into either Group A or Group B Intervention Group A Children included in
      Group A would be advised to carry out an individualized comprehensive home centred activity
      based programme. The investigator would interact with the primary care-giver and record the
      parent's anticipated goals in terms of the child's lower limb functioning; specifically gait,
      spasticity and daily functioning. The child would be clinically examined thoroughly to see
      for impairments. Subsequently a comprehensive individualized activity based programme will be
      decided upon by discussion between the investigator, physiotherapist and occupational
      therapist and primary care-giver so that it is acceptable and feasible to be performed at
      home in a resource limited setting.

      The programme would include simple activities which 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

      The total duration of activity would be one hour to start with and could be repeated to three
      times a day.

      The frequency of activity would be at least five days a week . Parents would be advised that
      in case the child has any acute illness, fever, muscle pain, they should withhold the
      sessions and seek early medical consultation at PGIMER or contact the investigator for
      advice.

      Group B Children included in Group B would continue to receive rehabilitative measures that
      they already are on in the form of conventional physiotherapy which 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 improvement No extra intervention would be advised to this group
           as a part of the study. At the completion of the study, if comprehensive individualized
           home-centred activity based therapy is found to be efficacious, the same will be offered
           to children classified under Group B .

      Follow-up Schedule

      All children would be followed at set intervals from initiation of therapy as noted below:

        1. Two weeks (telephonic/home visit)

        2. Three months : Physical follow-up

        3. Six months: Physical follow-up The first visit would be primarily aimed at reinforcing
           the techniques of therapy and clarifying parent's doubts.

      Compliance would be assessed by reviewing written log of activity done at home.

      At three-month visit the children would be clinically examined and following records made:

      (a) 6 minute walk score (in metres) (b) Modified Ashworth Score (b) Modified Tardieu Score
      (c) 10metre fast walk score (in metres) (d) GMFM D Score (e) GMFM E Score (f) CPQoL (Primary
      Care giver) Score

      At six-month visit the children would be clinically examined and following records made:

        1. Modified Ashworth Score

        2. Modified Tardieu Score

        3. 10metre fast walk score (in metres)

        4. GMFM D Score

        5. GMFM E Score

        6. CPQoL(Primary Caregiver) Score

      Statistical Analysis

      Statistics: Data record would be done in a Microsoft Excel spreadsheet (Microsoft Office,
      Microsoft Corp., Seattle, WA, USA).

      (i) Descriptive: Mean/Median/Range/Standard Deviation/Frequencies would be used to describe
      the demographic profile of patients and their comorbidities.

      (iii) Comparative: Appropriate tests would be employed

      Ethical justification The study consists of a comparative analysis between the effects of
      conventional physiotherapy and those of a comprehensive individualized home-centred
      activity-based programme on children with spastic diplegia. All children would be examined in
      detail and either of the interventions would be advised after random selection. Both of these
      interventions are beneficial and hence every child enrolled would be benefited. The children
      would be evaluated for co-morbidities and appropriate therapy advised as and when needed.
      This study would be beneficial in the long term in designing and recommending an effective
      exercise programme for spastic diplegics.

      No additional investigations will be done for the purpose of the study. Parents will have the
      privilege to withdraw their child from the study at any point of study period. This will in
      no way affect the standard protocol of management of the child. Children enrolled in the
      study would benefit by undergoing a comprehensive and standardized evaluation of their
      disabilities and getting the benefits of a regular rehabilitative programme.
    

Intervention name(s): Individualized comprehensive home centred activity based programme
Intervention type(s): Other
Intervention description(s): 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
Standing up from squatting position to catch an object of interest.
Squatting from standing position to pick an object of interest.
Walking to reach an object of interest.
Climbing up steps to get an object of interest.
Climbing down steps to keep the above object of interest.
Cycling
Kicking a football
Dancing
Other intervention name(s): Activity Based Therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: spastic diplegia;cerebral palsy;activity based therapy