NCT06303440

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 25, 2024

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

October 28, 2024

Status Verified

October 1, 2024

Enrollment Period

6 months

First QC Date

March 4, 2024

Last Update Submit

October 25, 2024

Conditions

Keywords

cerebral palsyMotor controlactivities of daily livingrandomized controlled trial

Outcome Measures

Primary Outcomes (3)

  • Gross Motor Function Classification System

    Gross Motor Function Classification System will be used to measure balance

    12 weeks

  • Bruininks-Oseretsky Test of motor function Proficiency-2

    It will be measured with Bruininks-Oseretsky Test of motor function Proficiency-2 for motor function.

    12 Weeks

  • Functional Independence Measure for Children

    Functional Independence Measure for Children scale will be used to determine the Activities of Daily Living improvement.

    12 Weeks

Study Arms (3)

Group A (Routine Physical Therapy+ Balance Training)

OTHER

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.

Other: Routine Physical Therapy+ Balance Training

Group B (Virtual Reality + Routine Physical Therapy)

EXPERIMENTAL

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.

Other: Virtual Reality+ Routine Physical Therapy

Group C (Motor Imagery+ Routine Physical Therapy)

EXPERIMENTAL

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

Other: Motor Imagery+ Routine Physical Therapy

Interventions

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 A (Routine Physical Therapy+ Balance Training)

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 B (Virtual Reality + 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.

Group C (Motor Imagery+ Routine Physical Therapy)

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 54660, Pakistan

Location

Related Publications (11)

  • 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.

    PMID: 31661938BACKGROUND
  • 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.

    PMID: 6641837BACKGROUND
  • 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.

    PMID: 23291508BACKGROUND
  • 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.

    PMID: 37372915BACKGROUND
  • 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.

    PMID: 21829120BACKGROUND
  • 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.

    PMID: 35488213BACKGROUND
  • 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.

    PMID: 37655192BACKGROUND
  • 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.

    PMID: 21206282BACKGROUND
  • 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.

    PMID: 19709140BACKGROUND
  • 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.

    PMID: 24237279BACKGROUND
  • 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.

    PMID: 32996138BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Muhammad Kashif, PhD-PT

    Riphah International University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2024

First Posted

March 12, 2024

Study Start

February 25, 2024

Primary Completion

August 31, 2024

Study Completion

August 31, 2024

Last Updated

October 28, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations