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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-19
SponsorIbadat International University, Islamabad

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Cognitive impairment (MMSE score <24).

History of seizure disorders.

Visual or hearing impairment that interferes with participation.

Diagnosed psychological or psychiatric disorders.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Meta Quest Pro Mixed Reality System

    Device

    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.

  • Standard Physical Therapy

    Other intervention

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Fully Immersive Mixed Reality + Standard Physical TherapyExperimental treatment 2 interventions
Group B: Standard Physical TherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Comprehensive Coordination Scale (CCS)

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.

Time frame
Baseline, Week 4, and Week 8
2

Pediatric Balance Scale (PBS)

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.

Time frame
Baseline, Week 4, and Week 8

Secondary outcomes

Other outcomes

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