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

13. oktober 2026 oppdatert av: Saoussen Layouni, Faculty of Medicine, Sousse

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

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.

Studieoversikt

Studietype

Intervensjonell

Registrering (Antatt)

30

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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Studiekontakt

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

4 år til 14 år (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 30 children between 5 to 14 years diagnosed with spastic hemiplegic cerebral palsy.

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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The Melbourne Assessment 2 (MA2)
Tidsramme: before and immediately after the intervention

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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Spasticity
Tidsramme: before and immediately after intervention

Spasticity through the Modified Ashworth Scale (MAS) for elbow and wrist ranging from 0 (normal tone) to 4 (rigid).

before and immediately after intervention
Muscle strength
Tidsramme: before and immediately after intervention

Muscle strength grading (MRC) ranging from 0 (no muscle activation) to 5 (normal muscle strength with full power against maximal resistance and a complete range of motion).

before and immediately after intervention
Passive Range of Motion
Tidsramme: before and immediately after intervention

Upper limb passive range of motion (PROM) in degrees measured with a goniometer.

before and immediately after intervention
The Box and Blocks Test
Tidsramme: before and immediately after intervention

Unilateral gross manual dexterity (The Box and blocks Test) for the affected limb scored by counting the total number of blocks safely transferred from one compartment to the other in 60 seconds (number of blocks per minute).

before and immediately after intervention
ABILHANDS-KIDS questionnaire
Tidsramme: before and immediately after intervention

Bimanual ability to manage daily life activities through ABILHANDS-KIDS questionnaire ranging from 0 to 42, with each task is assessed as "easy", "difficult" or "impossible". Raw scores are converted through a psychometric analysis (Rasch model) into a linear measure in logits on a continuous scale.

Higher score: Indicates a better manual ability and greater independence in daily life activities requiring the use of both hands.

Lower score: Reveals a significant activity limitation and an increased need for assistance in personal care.

before and immediately after intervention

Samarbeidspartnere og etterforskere

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Studierekorddatoer

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Studer hoveddatoer

Studiestart (Antatt)

1. oktober 2026

Primær fullføring (Antatt)

30. januar 2027

Studiet fullført (Antatt)

28. februar 2027

Datoer for studieregistrering

Først innsendt

21. september 2026

Først innsendt som oppfylte QC-kriteriene

26. september 2026

Først lagt ut (Faktiske)

2. oktober 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

16. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. oktober 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • Department of PMR Sousse

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