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

NCT02412007 | Completed DMC

• 1 other identifier: Activity Based Therapy in CP
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Diplegic Cerebral Palsy

Keywords

spastic diplegia;cerebral palsy;activity based therapy

Outcome Measures

Primary Outcomes (1)

• Change in distance covered as measured by 6 minute walk test (in metres)

  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.

  six months

Secondary Outcomes (5)

• Change in Modified Ashworth Scale Score

  3 months; 6 months

• Change in Modified tardieu Scale Score

  3 months; 6 months

• Change in 10metres fast walk score

  baseline, 3 months; 6 months

• Change in Gross Motor Function Measure 88 D & E Scores (GMFM-88 D & E)

  3 months; 6 months

• Change in Cerebral Palsy Quality of Life (Primary Care Giver ) Score (CPQoL)

  3 months; 6 months

Study Arms (2)

Group A

EXPERIMENTAL

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

Group B

ACTIVE COMPARATOR

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

Interventions

Individualized comprehensive home centred activity based programme OTHER

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

Also known as: Activity Based Therapy

Group A; Group B

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children of either sex aged 5 to 12 years clinically diagnosed to have spastic diplegic cerebral palsy .
• GMFCS either II or III
• Minimum visual acuity of 6/60
• Ability to follow simple single step commands
• Either parent should be willing and capable of following instructions and maintaining activity log.

You may not qualify if:

• Children with fixed contractures and deformities in lower limbs affecting stance and gait.
• Children who have received botulinum toxin injection or undergone orthopaedic corrective surgery in the past one year.
• Children with concomitant chronic systemic illnesses that can interfere with execution of physiotherapy or activity based therapy.
• Children with any acute illness.

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Postgraduate Institute of Medical Education and Research

Chandigarh, 160012, India

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Prof Pratibha Singhi, MD

  Post Graduate Institute of Medical Education and Research,Chandigarh,India

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Resident

Study Record Dates

• First Submitted: April 3, 2015
• First Posted: April 8, 2015
• Study Start: October 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: June 1, 2016
• Last Updated: October 21, 2019

Record last verified: 2019-10

Locations

IN (1)