Effects of Virtual Reality Versus Motor Imagery in Children With Cerebral Palsy

NCT ID: NCT06303440

Last Updated: 2024-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-25

Study Completion Date

2024-08-31

Brief Summary

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Cerebral palsy is a neurodevelopmental disorder caused by brain injury that appears in infancy, children have mostly issues of gross motor functions, and activities of daily living. Virtual Reality is an innovative technique for the improvement of balance and motor function in most of the neurological conditions. Motor Imagery is an ability to engage in the mental representation of a task consciously without generating a voluntary movement. The aim of this study is to determine the comparative effects of Virtual Reality and Motor Imagery on balance, gross motor function and activities of daily living in children with cerebral palsy.

Detailed Description

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This randomized controlled trial will be conducted at Rising Sun Institute. The sample size calculated for this trial will be 75. The participants will be randomly allocated using online randomization tool into three groups; Group A will receive routine physical therapy (PT) for 30 minutes with additional selected exercises for 15 minutes, Group B will receive VR training for 15 minutes with routine PT for 30 minutes, and Group C will receive MI for 15 minutes and routine PT for 30 minutes. Each participant will receive treatment for three days on alternative days per week for 12 weeks. Gross Motor Function Scale (GMFCS) will be used for balance, Bruininks-Oseretsky Test of motor function Proficiency-2 (BOT-2 ) for motor function, and WeeFIM scale for ADLs at baseline, 8th week, 12th week, and at 16th week after discontinuation of treatment.

Conditions

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Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The study would be single blinded as assessor of the study would be kept blind of the treatment groups to which patient will be allocated

Study Groups

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Group A (Routine Physical Therapy+ Balance Training)

The children will be provided with Routine Physical Therapy and Balance Training.

Balance exercises will be provided for 15 minutes and 30 minutes of Routine physical therapy will be as strengthening and stretching exercises.

Group Type OTHER

Routine Physical Therapy+ Balance Training

Intervention Type OTHER

Each session will be begun with routine PT treatment and lasted for 45 minutes in total. To start, the participants will be asked to do warm-up exercises, sitting comfortably on a chair with their backs and feet well supported, the participants will be instructed to breathe in and out. Warm-up exercises will be carried out for 5 minutes. Stretching exercises will be performed for 15 minutes per session, and stretches were held for 30 seconds with four repetitions of each of the following areas, shoulder flexors, elbow and wrist flexors, hip flexors, hip adductors, knee flexors, and calf, 10 seconds of rest period will be added after stretching of one muscle group. Participants will have a 15 minutes session of exercises neck holding on form roller for 1 minute with two repetitions, astride-sitting on foam roller for 2 minutes with four repetitions, weight on both hands on gym ball for 1 minute with two repetitions and hip adductors strengthening for 1 minute with three repetitions.

Group B (Virtual Reality + Routine Physical Therapy)

The VR system consisted of a wall-mounted display, a Nintendo Wii box, a Wii remote, and a Wii Fit board. The participants will be instructed to stand on Wii Fit board while interacting with the VR system and playing the selected games and routine physical therapy of 30 minutes will be provided.

Group Type EXPERIMENTAL

Virtual Reality+ Routine Physical Therapy

Intervention Type OTHER

The exercises will be selected, and the difficulty level will be gradually increased according to participant's performance. Starting from the penguin slide, they will progress to table tilt. Initially, each game will be played for 2 minutes per session. With the progression of performance, 4 minutes of table tilt will be added. While playing this game, a typical mobility pattern will be initiated, and balance will be improved. In the same week, the subjects performed single-leg extensions for 1 minutes. In the following weeks, Balance Bubble, Advanced step, and Basic Run will be added to the plan. The participants will perform these activities for 7 minutes per session. Treatment sessions then progressed to motor function games, including bowling, tennis, kicking, and boxing (least challenging to most challenging), with most treatment sessions ending with boxing will be provided for 7 minutes and routine physical therapy for 30 minutes as explained in control group.

Group C (Motor Imagery+ Routine Physical Therapy)

During the presentation of a video clip, patients will watch the video and afterwards try to do movement as same as shown in video

Group Type EXPERIMENTAL

Motor Imagery+ Routine Physical Therapy

Intervention Type OTHER

The 15 minutes of Motor Imagery session will be provided to participants. It's a three step process that will be used to incorporate the technique.

Step I, The self-recorded videos of the principal researcher performing a normal movements will be shown to participant.

Step II, The participants will be asked to imagine movement with eyes closed, and breathe deeply.

Step III The participants will be asked to perform the movement you watched in video and routine physical therapy of 30 minutes will be provided.

During the presentation of a video clip, patients will watch the video and afterwards try to do movement as same as shown in video.

Interventions

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Routine Physical Therapy+ Balance Training

Each session will be begun with routine PT treatment and lasted for 45 minutes in total. To start, the participants will be asked to do warm-up exercises, sitting comfortably on a chair with their backs and feet well supported, the participants will be instructed to breathe in and out. Warm-up exercises will be carried out for 5 minutes. Stretching exercises will be performed for 15 minutes per session, and stretches were held for 30 seconds with four repetitions of each of the following areas, shoulder flexors, elbow and wrist flexors, hip flexors, hip adductors, knee flexors, and calf, 10 seconds of rest period will be added after stretching of one muscle group. Participants will have a 15 minutes session of exercises neck holding on form roller for 1 minute with two repetitions, astride-sitting on foam roller for 2 minutes with four repetitions, weight on both hands on gym ball for 1 minute with two repetitions and hip adductors strengthening for 1 minute with three repetitions.

Intervention Type OTHER

Virtual Reality+ Routine Physical Therapy

The exercises will be selected, and the difficulty level will be gradually increased according to participant's performance. Starting from the penguin slide, they will progress to table tilt. Initially, each game will be played for 2 minutes per session. With the progression of performance, 4 minutes of table tilt will be added. While playing this game, a typical mobility pattern will be initiated, and balance will be improved. In the same week, the subjects performed single-leg extensions for 1 minutes. In the following weeks, Balance Bubble, Advanced step, and Basic Run will be added to the plan. The participants will perform these activities for 7 minutes per session. Treatment sessions then progressed to motor function games, including bowling, tennis, kicking, and boxing (least challenging to most challenging), with most treatment sessions ending with boxing will be provided for 7 minutes and routine physical therapy for 30 minutes as explained in control group.

Intervention Type OTHER

Motor Imagery+ Routine Physical Therapy

The 15 minutes of Motor Imagery session will be provided to participants. It's a three step process that will be used to incorporate the technique.

Step I, The self-recorded videos of the principal researcher performing a normal movements will be shown to participant.

Step II, The participants will be asked to imagine movement with eyes closed, and breathe deeply.

Step III The participants will be asked to perform the movement you watched in video and routine physical therapy of 30 minutes will be provided.

During the presentation of a video clip, patients will watch the video and afterwards try to do movement as same as shown in video.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Children of 7-12 years of both genders, Children with Mini Mental Scale score \>24.

Children with Gross motor function classification system (GMFCS) level I and II and able to follow and accept verbal instruction.

Exclusion Criteria

History of nerve, muscle, bone and joint diseases that seriously affect the movement function of the limbs and Children with history of severe cardiopulmonary disease, History of epilepsy, History of Fixed deformity of Lower limb. History of orthopaedic surgery and botulinum toxin injection.
Minimum Eligible Age

7 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Muhammad Kashif, PhD-PT

Role: STUDY_CHAIR

Riphah International University

Locations

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Riphah International University

Lahore, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

References

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Wu J, Loprinzi PD, Ren Z. The Rehabilitative Effects of Virtual Reality Games on Balance Performance among Children with Cerebral Palsy: A Meta-Analysis of Randomized Controlled Trials. Int J Environ Res Public Health. 2019 Oct 28;16(21):4161. doi: 10.3390/ijerph16214161.

Reference Type BACKGROUND
PMID: 31661938 (View on PubMed)

Nashner LM, Shumway-Cook A, Marin O. Stance posture control in select groups of children with cerebral palsy: deficits in sensory organization and muscular coordination. Exp Brain Res. 1983;49(3):393-409. doi: 10.1007/BF00238781.

Reference Type BACKGROUND
PMID: 6641837 (View on PubMed)

Chen CL, Shen IH, Chen CY, Wu CY, Liu WY, Chung CY. Validity, responsiveness, minimal detectable change, and minimal clinically important change of Pediatric Balance Scale in children with cerebral palsy. Res Dev Disabil. 2013 Mar;34(3):916-22. doi: 10.1016/j.ridd.2012.11.006. Epub 2013 Jan 3.

Reference Type BACKGROUND
PMID: 23291508 (View on PubMed)

Ortega-Martinez A, Palomo-Carrion R, Varela-Ferro C, Bagur-Calafat MC. Feasibility of a Home-Based Mirror Therapy Program in Children with Unilateral Spastic Cerebral Palsy. Healthcare (Basel). 2023 Jun 19;11(12):1797. doi: 10.3390/healthcare11121797.

Reference Type BACKGROUND
PMID: 37372915 (View on PubMed)

Brien M, Sveistrup H. An intensive virtual reality program improves functional balance and mobility of adolescents with cerebral palsy. Pediatr Phys Ther. 2011 Fall;23(3):258-66. doi: 10.1097/PEP.0b013e318227ca0f.

Reference Type BACKGROUND
PMID: 21829120 (View on PubMed)

Kashif M, Ahmad A, Bandpei MAM, Gilani SA, Hanif A, Iram H. Combined effects of virtual reality techniques and motor imagery on balance, motor function and activities of daily living in patients with Parkinson's disease: a randomized controlled trial. BMC Geriatr. 2022 Apr 30;22(1):381. doi: 10.1186/s12877-022-03035-1.

Reference Type BACKGROUND
PMID: 35488213 (View on PubMed)

Saleem GT. Defining and measuring motor imagery in children: mini review. Front Psychol. 2023 Aug 16;14:1227215. doi: 10.3389/fpsyg.2023.1227215. eCollection 2023.

Reference Type BACKGROUND
PMID: 37655192 (View on PubMed)

Collet C, Guillot A, Lebon F, MacIntyre T, Moran A. Measuring motor imagery using psychometric, behavioral, and psychophysiological tools. Exerc Sport Sci Rev. 2011 Apr;39(2):85-92. doi: 10.1097/JES.0b013e31820ac5e0.

Reference Type BACKGROUND
PMID: 21206282 (View on PubMed)

Steenbergen B, Craje C, Nilsen DM, Gordon AM. Motor imagery training in hemiplegic cerebral palsy: a potentially useful therapeutic tool for rehabilitation. Dev Med Child Neurol. 2009 Sep;51(9):690-6. doi: 10.1111/j.1469-8749.2009.03371.x.

Reference Type BACKGROUND
PMID: 19709140 (View on PubMed)

Steenbergen B, Jongbloed-Pereboom M, Spruijt S, Gordon AM. Impaired motor planning and motor imagery in children with unilateral spastic cerebral palsy: challenges for the future of pediatric rehabilitation. Dev Med Child Neurol. 2013 Nov;55 Suppl 4:43-6. doi: 10.1111/dmcn.12306.

Reference Type BACKGROUND
PMID: 24237279 (View on PubMed)

Souto DO, Cruz TKF, Fontes PLB, Haase VG. Motor imagery in children with unilateral cerebral palsy: a case-control study. Dev Med Child Neurol. 2020 Dec;62(12):1396-1405. doi: 10.1111/dmcn.14672. Epub 2020 Sep 29.

Reference Type BACKGROUND
PMID: 32996138 (View on PubMed)

Other Identifiers

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REC/RCR&AHS/23/0288

Identifier Type: -

Identifier Source: org_study_id

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