Full-Immersive Virtual Reality for Lower Limb Strength and Balance in Children With Hemiplegic Cerebral Palsy

NCT07792278 | Completed DMC

• 1 other identifier: P.T.REC/012/005126
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Hemiplegic cerebral palsy (HCP) is a neurological disorder that affects one side of the body, resulting in muscle weakness and impaired balance. Virtual reality (VR) is a promising tool in pediatric rehabilitation due to its engaging and interactive nature. Aim: To investigate the effect of VR on lower-limb muscle strength and balance in children with HCP. Methods:30 children with HCP aged 7-10 years were randomly allocated to two equal groups. The control group received a selected physical therapy program, whereas the study group received the same program combined with fully immersive VR training. The total treatment period was 8 weeks. Lower-limb muscle strength was assessed using a Lafayette hand-held dynamometer. The Five Times Sit-to-Stand Test was used to assess functional lower-limb strength, and the Pediatric Balance Scale was used to assess balance.

Conditions

Hemiplegic Cerebral Palsy

Keywords

Cerebral Palsy; Balance; Hemiplegic Cerebral Palsy; Virtual Reality

Outcome Measures

Primary Outcomes (1)

• Lafayette hand-held dynamometer (HHD)

  \[Model: 01163, Lafayette Instrument Company, USA\] was used for objective measurement of isometric muscle strength of the hip, knee muscle groups. The HHD was calibrated by the manufacturer before assessment. Hip flexors and knee extensors were assessed in a sitting position; hip abductors were assessed in a supine posture; and hip extensors and knee flexors were assessed in a prone position. The child was assessed in three distinct positions: supine, prone, and sitting. The child was asked to perform two warm-up trials at sub maximal effort without the transducer being placed on the limb. Transducer was subsequently placed on the limb, and the child performed three maximal attempts lasting 5 seconds each, with a 30-second rest interval between trials. The child was instructed and verbally prompted to exert maximal force during the test, while the examiner resisted the child's maximal voluntary contraction, representing the maximal isometric force. Peak isometric presented in Newtons.

  1. Pre-treatment at base-line of the study. 2. Post-treatment after 8 weeks of intervention.

Secondary Outcomes (2)

• Five-Repetition Sit-to-Stand Test (FTSST)

  1. Pre-treatment at base-line of the study. 2. Post-treatment after 8 weeks of intervention.

• The Pediatric Balance Scale (PBS)

  1. Pre-treatment at base-line of the study. 2. Post-treatment after 8 weeks of intervention.

Other Outcomes (2)

• Modified Ashworth Scale (MAS)

  1. Pre-treatment at base-line of the study.

• Gross Motor Function Classification System (GMFCS)

  1. Pre-treatment at base-line of the study.

Study Arms (2)

Control Group (A)

ACTIVE COMPARATOR

Children in both groups received a physical therapy program according to Neurodevelopmental Treatment (NDT) principles. Equipment included mats, rolls, therapy balls, weights, and balance boards. Sessions lasted 60 minutes and were conducted three times weekly for 8 consecutive weeks. The program addressing the following: 1) muscle strengthening exercises in the form of functional exercises such as straight-leg raises, heel slides, and bridging (hip lift) and sit-to-stand from a chair exercises to engage core and lower-limb muscles. 2) gentle stretching for tight muscle groups, particularly the hamstrings, calf muscles, and hip flexors, 3) Supported standing exercises, 4) Dynamic and static balance activities, 5) gait training including obstacle walking, high-knee walking, and dual-tasking.

Other: A selected physical therapy program

Study Group (B)

EXPERIMENTAL

Children in the study group only were given the same selected program as the control group, along with VR training using two interactive VRapeutic therapeutic games. Viblio, and Garden Do modules were chosen for their focus on functional, engaging virtual tasks that require movement and balance. VR sessions were conducted for 20-30 minutes each, three times weekly, across 8-week duration. The equipment included VRapeutic immersive rehabilitation system (VRapeutic Inc.); Lenovo IdeaPad 110 laptop (Intel Core i5-6200U CPU, 16 GB RAM, AMD Radeon R5 M430 GPU) running the VRapeutic software (developed with Unity™ 2019.4.40f1 LTS), Oculus Quest 2 VR headset (head-mounted display with 1440×1600 resolution per eye and a 96°×94° field of view), and two Oculus Touch handheld controllers, LED screen (43") was also used to guide the session

Other: A selected physical therapy program; Other: Fully Immersive Virtual Reality

Interventions

A selected physical therapy program OTHER

A selected physical therapy program based on NDT principles according to for 60 minutes, 3 times/week for 6 successive weeks including the following exercises: strengthening exercises, stretching exercises, facilitation of postural reactions from standing position including: standing on one leg, weight shifting from standing position, stoop and recover from standing, squat from standing, standing on balance board and pushing the child in different directions and gait training activities for correction of gait pattern including: walking on balance beam, walking on balance board, walking on uneven surface, walking using different obstacles (rolls, wedges, stepper) and walking up and down stairs

Control Group (A); Study Group (B)

Fully Immersive Virtual Reality OTHER

Children in the study group only were given the same selected program as the control group, along with VR training using two interactive VRapeutic therapeutic games. Viblio, and Garden Do modules were chosen for their focus on functional, engaging virtual tasks that require movement and balance. VR sessions were conducted for 20-30 minutes each, three times weekly, across 8-week duration. The equipment included VRapeutic immersive rehabilitation system (VRapeutic Inc.); Lenovo IdeaPad 110 laptop (Intel Core i5-6200U CPU, 16 GB RAM, AMD Radeon R5 M430 GPU) running the VRapeutic software (developed with Unity™ 2019.4.40f1 LTS), Oculus Quest 2 VR headset (head-mounted display with 1440×1600 resolution per eye and a 96°×94° field of view), and two Oculus Touch handheld controllers, LED screen (43") was also used to guide the session

Study Group (B)

Eligibility Criteria

• Age: 7 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Their Ages ranged from 7to10 years chronologically.
• Both genders will be included.
• They are able to understand and follow simple verbal commands or instructions included in both assessment and training procedures.
• Their degree of spasticity will range from 1 to 1+ according to the Modified Ashworth Scale
• Their motor function will be at level I according to Gross Motor Function Classification System

You may not qualify if:

• Bony joint limitation or skeletal deformities in lower limb.
• Surgeries (Tenotomy or muscle transfer in the affected lower limb) at last 6 months before the study.
• Botox injection at last 6 months before the study.
• Visual or auditory abnormalities.

Sponsors & Collaborators

• Adly A Adam: lead

Study Sites (1)

Faculty of Physical Therapy

Cairo, Cairo Governorate, 11432, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

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

Study Officials

• Gehan H El-Meniawy, Professor

  Cairo University; Faculty of Physical Therapy

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Another researcher via an opaque envelopes involved number defining the 80 post stroke participants, then randomly allocated
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physical Therapy Specialist

Model Details: Random controlled trial

Study Record Dates

• First Submitted: August 22, 2026
• First Posted: August 28, 2026
• Study Start: May 10, 2024
• Primary Completion: March 1, 2026
• Study Completion: June 30, 2026
• Last Updated: August 28, 2026

Record last verified: 2026-08

Locations

EG (1)