Virtual Reality Training With Sensory Integration On The Gross Motor Functions Of Lower Limb

Not Applicable

Completed

• Conditions: Cerebral Palsy Spastic Diplegia
• Interventions: Other: VR training + Sensory Integration therapy + conventional therapy; Other: VR training + conventional therapy

• Registration Number: NCT04467385
• Lead Sponsor: Riphah International University

Brief Summary

The objectives of this study are To determine the effect of virtual reality on balance and gross motor functions of the lower limb in spastic diplegic cerebral palsy. To determine the effect of virtual reality with sensory input on balance and gross motor functions of the lower limb in spastic diplegic cerebral palsy. To compare the effects of virtual reality training with and without sensory input on balance and gross motor functions of the lower limb in spastic diplegic CP. Its is a Randomized control trial (RCT) done at Physiotherapy department of Railway General Hospital Rawalpindi and National Institute of rehabilitation Medicine.44 individuals (calculated using epi tool) 22 individuals in each group. Individuals who met the inclusion criteria will be included in this study. All participants will go through randomization and divided into two groups Experimental and Control groups. Pre-intervention assessment is made for both groups. Then intervention will be applied to both groups. estimated time of treatment protocol will be 40 min/day, 1 time / d, 3 times/week for 6 weeks. Subjects will be evaluated at baseline, then 3rd week and 6th-week assessment will be the final

Detailed Description

Cerebral Palsy(CP) is a common non-progressive disorder that occurs due to any injury or aberration to the developing central nervous system. It refers to the disorders that stem from primary brain lesion leading to musculoskeletal and nervous abnormalities in the pediatric population. Cerebral palsy has a global incidence of 1-3.5 cases per 1000 live births. The most prevalent type is spastic diplegia which occurs in 30-40% of spastic cerebral palsy. According to motor impairment, it is classified into spastic, dyskinetic and ataxic cerebral palsy. The children with cerebral palsy have very poor control of voluntary muscle activity. Therefore training of selective motor control in children with cerebral palsy is an important part of physiotherapy intervention. Children are often not amenable to the conventional exercise program but studies have demonstrated that children show high interest and stimulation to virtual reality training. Virtual reality is a virtual environment system that enables a person to witness situations and actions similar to real-life. Therapists use Virtual reality systems to create a fascinating environment to gain targeted therapeutic goals. Sensory integration, on the other hand, is a therapeutic approach that involves active therapy and activities involving graded sensory experiences. It provides keen proprioceptive and tactile experiences. Sensory integration therapy usually involves balls, rolls, hammock, trampolines and altering surfaces. Children with spastic diplegia have gross and fine motor, sensory, cognitive impairments. This results in reduced ability to adjust the body and balance it with movements. Postural control demands active sensorimotor control. Exercise with mini-trampoline is designed for balance training to improve static and dynamic balance and postural adjustment in children with spastic diplegia. According to a study in 2016, Virtual reality training can effectively improve the gross motor function of the lower limbs in children with spastic diplegia in comparison to conventional therapy. As claimed by a study in, 2006 VR training in combination with conventional exercise therapy in spastic CP improves exercise compliance and enhance exercise effectiveness. It is a simple and executable approach which can be used by any skilled therapist as an independent treatment method to improve the outcome.

According to a study, sensory integration therapy had a measurable effect in children with spastic diplegic cerebral palsy who suffer from a sensory-motor deficit. A study observed the effects of sensory integration therapy in children with cerebral palsy and concluded that sensory integration therapy has a positive effect on gross motor function in spastic diplegic CP in sitting and standing positions. Whereas, the control group with only home exercise program showed no significant improvement.In 2018 compared the effects of rebound exercises and simple balance training on balance of spastic diplegic children. The assessments suggested that balance was improved in both groups but the group under study showed a significant difference and concluded that rebound exercises improve the balance and postural control. The past research records are evident that therapists have worked with either Virtual reality training or Sensory integration therapy for the rehabilitation of Spastic Diplegic children. The two protocols have not been complimented for rehabilitation. So the aim of this study is to observe and determine the combined effect of these two treatment protocols to get the results and improve the gross motor function in lower limbs of CP children.

Study Timeline

• Study Start: 2019-06-15
• Primary Completion: 2019-12-15
• Study Completion: 2020-01-15
• Study First Submitted: 2020-03-18
• Status Verified: 2020-07
• Study First Submitted QC: 2020-07-08
• Last Update Submitted: 2020-07-08
• Study First Posted: 2020-07-13
• Last Update Posted: 2020-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Diplegic CP children aged 5-12 years
• Gross motor function classification system System (GMFCS) I - II
• Children can be independent Walking distance >5 meters
• Spasticity of lower limb < 3 ..
• A child able to understand command and can play VR games.

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Exclusion Criteria

• Any Bone and joint diseases
• Epilepsy
• Mental illness
• Mental retardation etc. cannot be matched with the completion of the experiment.
• Any history of taking anticonvulsant drugs or muscle relaxants.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	VR training + Sensory Integration therapy + conventional therapy	Virtual Reality training(VR) + Sensory Integration therapy + conventional therapy
Control Group	VR training + conventional therapy	VR training + conventional therapy

Primary Outcome Measures

Name	Time	Method
Pediatric Balance Scale (PBS):	Changes from baseline to 6th month	Pediatric Balance Scale (PBS) is a modification of Berg Balance Scale was developed as a balance measure for children with mild to moderate motor impairments.
Gross Motor Function Measure (GMFM-88)	Changes from baseline to 6th month	Its an 88-item tool for assessing and measuring changes in gross motor function in children with cerebral palsy. It's a four pint scale from 0-3 that indicates the grading of a specified task and the tool is further divided into five categories.
2 min walk Test (2MWT)	Changes from baseline to 6th month	The Two/2 Minute Walk Test (2 MWT) is a measure of self-paced walking ability and functional capacity. The 2 MWT is a simple measure of the distance a person can walk in two minutes. Rest breaks are allowed if needed. The person is encouraged to walk as fast as they can, safely, for two minutes. Walking aids can be used as needed.

Trial Locations

Locations (1)

Riphah International University; 🇵🇰 Islamabad, Federal, Pakistan