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Comparing Mixed Reality and Physical Therapy to Improve Balance and Coordination in Adolescents With Spastic Diplegic Cerebral Palsy

29. juni 2026 oppdatert av: Ibadat International University, Islamabad

Effect Of Fully Immersive Mixed Reality Versus Standard Physical Therapy For Improving Balance And Coordination In Adolescent With Spastic Diplegic Cerebral Palsy" A Randomized Controlled Trial

This randomized controlled trial aims to compare the effectiveness of fully immersive Mixed Reality (MR) combined with standard physical therapy versus standard physical therapy alone in improving balance and coordination among adolescents with spastic diplegic cerebral palsy. A total of 40 participants aged 10 to 19 years will be randomly assigned to one of two treatment groups. The intervention will be provided three times per week for eight weeks. Balance and coordination will be assessed before treatment, at four weeks, and after completion of the intervention using validated clinical outcome measures. The findings of this study may help determine whether immersive Mixed Reality can enhance rehabilitation outcomes in adolescents with cerebral palsy.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

erebral palsy (CP) is one of the most common neurological disorders affecting movement, balance, posture, and coordination in children and adolescents. Spastic diplegic cerebral palsy is characterized by increased muscle tone predominantly affecting the lower limbs, resulting in impaired balance, reduced coordination, and limitations in functional mobility. Conventional physical therapy is considered the standard rehabilitation approach; however, patient motivation and treatment adherence may limit its effectiveness.

Mixed Reality (MR) technology provides an immersive and interactive rehabilitation environment that combines virtual and real-world elements, enabling repetitive, task-oriented training with real-time feedback. Such interventions may enhance motor learning, neuroplasticity, patient engagement, and functional recovery. Despite promising evidence regarding immersive virtual reality interventions, limited randomized controlled trials have compared fully immersive Mixed Reality with conventional physical therapy in adolescents with spastic diplegic cerebral palsy.

This single-blinded randomized controlled trial aims to compare the effectiveness of fully immersive Mixed Reality combined with standard physical therapy versus standard physical therapy alone in improving balance and coordination among adolescents with spastic diplegic cerebral palsy. A total of 40 participants aged 10-19 years who meet the eligibility criteria will be recruited and randomly allocated into two equal groups. Group A will receive fully immersive Mixed Reality training using the Meta Quest Pro platform in combination with standardized physical therapy, while Group B will receive standardized physical therapy alone. Both groups will receive treatment three sessions per week for eight weeks.

Outcome assessments will be performed at baseline, after four weeks, and after completion of the eight-week intervention. Balance will be evaluated using the Pediatric Balance Scale (PBS), while coordination will be assessed using the Comprehensive Coordination Scale (CCS). The findings of this study will provide evidence regarding the effectiveness of fully immersive Mixed Reality as an adjunct to conventional physical therapy and may contribute to improving rehabilitation strategies for adolescents with spastic diplegic cerebral palsy.

Studietype

Intervensjonell

Registrering (Antatt)

40

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Pakistan
    • Kpk
      • Mansehra, Kpk, Pakistan, 21300
        • Rekruttering
        • Helping hand Comprehansive Physical Rehabilitation Center Mansehra
        • Ta kontakt med:

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

  • Barn
  • Voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Male and female participants.
  • Adolescents aged 10 to 19 years.
  • Clinically diagnosed with spastic diplegic cerebral palsy.
  • Gross Motor Function Classification System (GMFCS) Levels I, II, or III.
  • Pediatric Balance Scale (PBS) score greater than 35.
  • Willing to participate in the study and provide written informed consent/assent with parental or legal guardian consent where applicable.

Exclusion Criteria:

  • Cognitive impairment (MMSE score <24).
  • History of seizure disorders.
  • Visual or hearing impairment that interferes with participation.
  • Diagnosed psychological or psychiatric disorders.
  • Any other medical condition that would prevent safe participation in the study.

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: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Fully Immersive Mixed Reality + Standard Physical Therapy
Participants assigned to the experimental arm will receive fully immersive Mixed Reality (MR) using the Meta Quest Pro platform in combination with standardized physical therapy. The MR intervention will include interactive applications designed to improve balance and coordination. Standard physiotherapy will include balance training, gait training, beam walking, wobble board exercises, cone weaving, stretching, and strengthening exercises. Treatment will be provided three sessions per week for eight weeks.
Enhet: Meta Quest Pro Mixed Reality System
Participants will receive fully immersive Mixed Reality rehabilitation using the Meta Quest Pro headset in combination with standardized physical therapy. The intervention includes interactive applications such as Beat Saber, Ball Balance, Run and Cycling, Running Monkeys, and Back to Subway Surfer. Treatment will be provided three sessions per week for eight weeks to improve balance and coordination in adolescents with spastic diplegic cerebral palsy.
Annen: Standard Physical Therapy
Participants will receive standardized physical therapy consisting of balance training, tandem gait exercises, beam walking, wobble board exercises, cone weaving, stretching, strengthening exercises, patient education, and a home exercise program. Treatment will be provided three sessions per week for eight weeks.
Aktiv komparator: Standard Physical Therapy
Participants assigned to the control arm will receive standardized physical therapy alone, including balance training, gait training, beam walking, wobble board exercises, cone weaving, stretching, strengthening exercises, patient education, and a home exercise program. Treatment will be provided three sessions per week for eight weeks.
Annen: Standard Physical Therapy
Participants will receive standardized physical therapy consisting of balance training, tandem gait exercises, beam walking, wobble board exercises, cone weaving, stretching, strengthening exercises, patient education, and a home exercise program. Treatment will be provided three sessions per week for eight weeks.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Comprehensive Coordination Scale (CCS)
Tidsramme: Baseline, Week 4, and Week 8
The Comprehensive Coordination Scale (CCS) will be used to assess motor coordination in adolescents with spastic diplegic cerebral palsy. Scores will be compared between the intervention and control groups to determine the effect of the interventions on coordination.
Baseline, Week 4, and Week 8
Pediatric Balance Scale (PBS)
Tidsramme: Baseline, Week 4, and Week 8
The Pediatric Balance Scale (PBS) will be used to evaluate functional balance in adolescents with spastic diplegic cerebral palsy. Scores will be compared between the intervention and control groups to determine the effect of the interventions on balance.
Baseline, Week 4, and Week 8

Samarbeidspartnere og etterforskere

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Sponsor

Ibadat International University, Islamabad

Etterforskere

  • Hovedetterforsker: Muhammad Yaseen Khattak, MS-PPT, Ibadat International University, Islamabad

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

12. januar 2026

Primær fullføring (Antatt)

1. juli 2026

Studiet fullført (Antatt)

1. august 2026

Datoer for studieregistrering

Først innsendt

29. juni 2026

Først innsendt som oppfylte QC-kriteriene

29. juni 2026

Først lagt ut (Faktiske)

6. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. juni 2026

Sist bekreftet

1. januar 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • IIUI/RERC/ADT/2026/01/214

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Individual participant data (IPD) will not be made publicly available because of participant confidentiality, privacy considerations, and institutional policies.

Legemiddel- og utstyrsinformasjon, studiedokumenter

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Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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