Comparison of Effectiveness of Home Based Sensory Interventions Along With Standard Therapy Versus Standard Therapy Alone in Autistic Children With Sensory Processing Abnormalities

NCT ID: NCT02491645

Last Updated: 2018-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2017-12-31

Brief Summary

Around 69-95% of children with Autistic Spectrum Disorder are known to have sensory processing abnormalities .Tackling these problems would help in better quality of life, both for the parents and the children. Sensory integration therapy, an individualized clinic based therapy have been shown to have a positive effect on those children with sensory abnormalities. Hence the investigators are doing this study , to primarily look into the efficacy and feasibility of home based sensory interventions in autistic children with sensory processing abnormalities.

Conditions

Autistic Children With Sensory Processing Abnormalities

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention group

Children would receive both standard therapy and home based sensory interventions as described below,

• Standard therapy - children would receive measures like speech and language services, behavioral interventions and educational program regularly as and when decided by the primary care physician. They would be individualized to child specific needs .
• Home based sensory interventions - children would receive home based sensory interventions targeting visual and auditory system, tactile abnormalities, proprioceptive and vestibular abnormalities.These interventions would be carried out daily , at least 5 days a week, for a minimum duration of 1hour/day.

Group Type: EXPERIMENTAL

Sensory interventions

Intervention Type: OTHER

1. Tactile stimulation: Brushing technique , handling materials of various textures, bear hug and rug , play dough and find in rice techniques to be done.

2. Proprioception technique : Joint compression , popping bubbles, lifting weights of different measures and scooter board push activities to be done.

3. Movement/vestibular techniques :Bear hug and rug , swinging or rocking motion, jumping or spinning to be done.

4. Visual stimulation : picture recognition, dot colouring , lighting balls and toys , familiarisation of emotions to be done.

5. Auditory stimulation : Sound familiarisation and music time will be done.

Control group

This group of children would receive only standard therapy as described below, Standard therapy - children would receive measures like speech and language services, behavioral interventions and educational program regularly as and when decided by the primary care physician. They would be individualized to child specific needs.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Sensory interventions

1. Tactile stimulation: Brushing technique , handling materials of various textures, bear hug and rug , play dough and find in rice techniques to be done.

2. Proprioception technique : Joint compression , popping bubbles, lifting weights of different measures and scooter board push activities to be done.

3. Movement/vestibular techniques :Bear hug and rug , swinging or rocking motion, jumping or spinning to be done.

4. Visual stimulation : picture recognition, dot colouring , lighting balls and toys , familiarisation of emotions to be done.

5. Auditory stimulation : Sound familiarisation and music time will be done.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Children between the age group of 3-12years with autistic spectrum disorder as per DSM -V criteria along with CARS and those having sensory abnormalities as screened by short sensory profile 2 will be included in the study group

2. Parents who agreed for home based sensory intervention therapy with strict adherence to same and to refrain from initiation of any new treatments including medications during study period

Exclusion Criteria

1. Children with epileptic syndromes with language regression(LKS)

2. Children with features of ASD but having underlying structural(TS), neurometabolic or primary epilepsy as etiology

3. Children with uncontrolled seizures (seizures in the last 06 months)

4. Children whose parents do not give consent for the study

5. Children for whom follow up would not be feasible

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role: lead

Responsible Party

Dr Hansashree P

Senior resident , pursuing DM Pediatric neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr Hansashree Padmanabha, MD

Role: PRINCIPAL_INVESTIGATOR

Post Graduate Institute of Medical Education and Research, Chandigarh

Locations

Dr Hansashree P

Chandigarh, , India

Countries

India

Other Identifiers

PGIMER-HS

Identifier Type: -

Identifier Source: org_study_id