Virtual Reality-Augmented Constraint-Induced Movement Therapy Versus Conventional Constraint-Induced Therapy for Upper Limb Rehabilitation in Children With Unilateral Cerebral Palsy.

NCT07853937 | Not Yet Recruiting

• 1 other identifier: Department of PMR Sousse
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Cerebral palsy (CP) causes persistent motor and postural impairments that can limit children's functional independence and participation. Upper-limb rehabilitation traditionally relies on conventional therapies, while Virtual Reality (VR) provides an immersive, engaging environment that can improve motor function and quality of life. Constraint-Induced Movement Therapy (CIMT) promotes intensive use of the affected upper limb and has demonstrated benefits in motor and functional outcomes. Recent evidence suggests that combining VR with CIMT (VRCIT) may further improve upper-limb function, hand manipulation, and dexterity. However, in Tunisia, access to CIMT and VR-based rehabilitation remains limited, and no Tunisian study has yet evaluated the effectiveness of VRCIT in children with unilateral CP, highlighting an important research gap. Aim: Evaluate the effectiveness of Virtual Reality-Augmented Constraint-Induced Movement Therapy and constraint-induced movement therapy only in improving unimanual upper limb function in children with unilateral cerebral palsy.

Conditions

Cerebral Palsy Spastic Hemiplegic, Quality of Movement

Outcome Measures

Primary Outcomes (1)

• The Melbourne Assessment 2 (MA2)

  The Melbourne Assessment 2 (MA2) is a standardized assessment tool used to evaluate the quality of unilateral (one-sided) upper limb function in children with neurological impairments. It focuses on assessing the range of movement, accuracy, dexterity, and fluency of the child's upper limb during specific tasks. It reports a child's performance as four separate percentage scores corresponding to each measured element of movement quality.

  before and immediately after the intervention

Secondary Outcomes (5)

• Spasticity

  before and immediately after intervention

• Muscle strength

  before and immediately after intervention

• Passive Range of Motion

  before and immediately after intervention

• The Box and Blocks Test

  before and immediately after intervention

• ABILHANDS-KIDS questionnaire

  before and immediately after intervention

Study Arms (1)

30 children between 5 to 14 years diagnosed with spastic hemiplegic cerebral palsy.

EXPERIMENTAL

Other: Rehabilitation intervention

Interventions

Rehabilitation intervention OTHER

All participants will undergo two assessment sessions, one at baseline and one at the end of the program. Clinical testing will consist of physical examination, assessing unimanual function through the Melbourne Assessment 2 (MA2), unilateral gross manual dexterity (The Box and blocks Test), spasticity through the Modified Ashworth Scale (MAS) for elbow and wrist, muscle strength grading (MRC), upper limb passive range of motion (PROM), and bimanual ability through ABILHANDS-KIDS questionnaire. The clinical outcome measures will be recorded by a researcher-resident in physical medicine and rehabilitation. After obtaining the oral consent of the participants' legal guardians, those who met the inclusion criteria will be divided in two groups: The first group will receive a CIMT program, the second group will undergo a VRCIT based-rehabilitation program, both for a period of two weeks. A clinical evaluation will be performed one day before the program.

30 children between 5 to 14 years diagnosed with spastic hemiplegic cerebral palsy.

Eligibility Criteria

• Age: 4 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Able to handle objects in daily life within levels I, II and III on the Gross Motor Function Classification System.
• Absence of musculoskeletal disorders that impaired the ability of children to use the VR system.
• Normal or corrected hearing and vision.
• Able to understand and follow simple directions and perform requested tasks.
• Tutor Consent.

You may not qualify if:

• Dizziness during VR sessions.
• Intolerance to VR environments.
• Unable to continue or follow the CIMT or VR program.

Sponsors & Collaborators

• Faculty of Medicine, Sousse: lead

Study Sites (1)

Department of PMR Sousse

Sousse, 4000, Tunisia

Location

Central Study Contacts

Saoussen Layouni, Associate professor

CONTACT

52785163; layouni.saoussen@FAMSO.u-sousse.tn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: September 21, 2026
• First Posted: October 2, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-09

Locations

TU (1)