- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07685327
Comparing Mixed Reality and Physical Therapy to Improve Balance and Coordination in Adolescents With Spastic Diplegic Cerebral Palsy
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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Muhammad Ashar Rafi, PhD*
- Telefonnummer: 923083407837
- E-mail: Ashar.rafi@uipt.iiui.edu.pk
Undersøgelse Kontakt Backup
- Navn: Muhammad Yaseen Khattak, MS-PPT
- Telefonnummer: 923115563552
- E-mail: yaseenkhattak391@gmail.com
Studiesteder
-
-
Kpk
-
Mansehra, Kpk, Pakistan, 21300
- Rekruttering
- Helping hand Comprehansive Physical Rehabilitation Center Mansehra
-
Kontakt:
- Muhammad Yaseen Khattak, MS-PPT
- Telefonnummer: 03440957080
- E-mail: yaseenkhattak391@gmail.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
Tager imod sunde frivillige
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
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.
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.
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Muhammad Yaseen Khattak, MS-PPT, Ibadat International University, Islamabad
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IIUI/RERC/ADT/2026/01/214
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .