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

NCT04467385 | Completed

• 1 other identifier: REC/00557 Sannia Batool
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Conditions

Cerebral Palsy Spastic Diplegia

Keywords

Virtual Reality; Spastic Diplegic Cerebral Palsy; Sensory Integration

Outcome Measures

Primary Outcomes (3)

• Pediatric Balance Scale (PBS):

  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.

  Changes from baseline to 6th month

• Gross Motor Function Measure (GMFM-88)

  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.

  Changes from baseline to 6th month

• 2 min walk Test (2MWT)

  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.

  Changes from baseline to 6th month

Study Arms (2)

Experimental Group

EXPERIMENTAL

Virtual Reality training(VR) + Sensory Integration therapy + conventional therapy

Other: VR training + Sensory Integration therapy + conventional therapy

Control Group

EXPERIMENTAL

VR training + conventional therapy

Other: VR training + conventional therapy

Interventions

VR training + Sensory Integration therapy + conventional therapy OTHER

After the baseline assessment, * Coconut ShootersVR - 5 min/day * Ninja flipVR - 5 min/day. * Sensory integration training include Exercises on BOSU ball and mini-trampoline. It will involve: * Passive bouncing with child standing with his/her feet shoulder width apart for 2.5 and 2.5 minutes on both. * Active bouncing (the child bounces and therapist will control the rate) for 2.5 and 2.5 minutes on both. * Mini-squat exercises with feet apart and feet together for 2.5 and 2.5 minutes on both. * Conventional exercises include: * passive stretching exercises for the hip flexors, hip adductors, hamstring, and calf muscle; stretching will be applied for 30 sec with 30 sec rest for each muscle group within pain limit. * Strengthening of abdominal and back muscles, hip abductions and knee joint extensors and ankle dorsiflexors will be performed.

Experimental Group

VR training + conventional therapy OTHER

After the baseline assessment, * The Your Shape: Fitness Evolved 2012TM game is selected for VR training (walking and walking with obstacles) for 8 min * Coconut ShootersVR - 8 min/day * Ninja flipVR - 8 min/day * Conventional Therapy - 20 min per day * Passive stretching exercises for the hip flexors, hip adductors, hamstring, and calf muscle; stretching will be applied for 30 sec with 30 sec rest 3-5 times for each muscle group within pain limit. * Strengthening of abdominal and back muscles, hip abductions and knee joint extensors and ankle dorsiflexors will be performed.

Control Group

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah International University

Islamabad, Federal, 44000, Pakistan

Location

Related Publications (7)

• Bumin G, Kayihan H. Effectiveness of two different sensory-integration programmes for children with spastic diplegic cerebral palsy. Disabil Rehabil. 2001 Jun 15;23(9):394-9. doi: 10.1080/09638280010008843.

  PMID: 11394590 BACKGROUND

• Lazzari RD, Politti F, Santos CA, Dumont AJ, Rezende FL, Grecco LA, Braun Ferreira LA, Oliveira CS. Effect of a single session of transcranial direct-current stimulation combined with virtual reality training on the balance of children with cerebral palsy: a randomized, controlled, double-blind trial. J Phys Ther Sci. 2015 Mar;27(3):763-8. doi: 10.1589/jpts.27.763. Epub 2015 Mar 31.

  PMID: 25931726 BACKGROUND

• Bulekbayeva S, Daribayev Z, Ospanova S, Vento S. Cerebral palsy: a multidisciplinary, integrated approach is essential. Lancet Glob Health. 2017 Apr;5(4):e401. doi: 10.1016/S2214-109X(17)30082-7. No abstract available.

  PMID: 28288745 BACKGROUND

• Bryanton C, Bosse J, Brien M, McLean J, McCormick A, Sveistrup H. Feasibility, motivation, and selective motor control: virtual reality compared to conventional home exercise in children with cerebral palsy. Cyberpsychol Behav. 2006 Apr;9(2):123-8. doi: 10.1089/cpb.2006.9.123.

  PMID: 16640463 BACKGROUND

• Snider L, Majnemer A, Darsaklis V. Virtual reality as a therapeutic modality for children with cerebral palsy. Dev Neurorehabil. 2010;13(2):120-8. doi: 10.3109/17518420903357753.

  PMID: 20222773 BACKGROUND

• Galli M, Cimolin V, Pau M, Leban B, Brunner R, Albertini G. Foot pressure distribution in children with cerebral palsy while standing. Res Dev Disabil. 2015 Jun-Jul;41-42:52-7. doi: 10.1016/j.ridd.2015.05.006. Epub 2015 Jun 6.

  PMID: 26057837 BACKGROUND

• Ren K, Gong XM, Zhang R, Chen XH. [Effects of virtual reality training on limb movement in children with spastic diplegia cerebral palsy]. Zhongguo Dang Dai Er Ke Za Zhi. 2016 Oct;18(10):975-979. doi: 10.7499/j.issn.1008-8830.2016.10.011. Chinese.

  PMID: 27751214 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

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

Study Officials

• Aruba Saeed, PHD*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2020
• First Posted: July 13, 2020
• Study Start: June 15, 2019
• Primary Completion: December 15, 2019
• Study Completion: January 15, 2020
• Last Updated: July 13, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)