Clinical trial · Interventional
Virtual Reality-Assisted Exercise in Pediatric Hematopoietic Stem Cell Transplantation
Effects of Virtual Reality-Assisted Video Game-Based Exercise Training on Functional Level, Respiratory Parameters, and Physical Fitness in Pediatric Patients After Hematopoietic Stem Cell Transplantation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This randomized controlled, single-blind clinical trial investigates whether virtual reality (VR)-assisted, video game-based exercise training, added to a conventional pulmonary physiotherapy and rehabilitation program, improves functional level, respiratory parameters, and physical fitness in pediatric patients (5-18 years) following hematopoietic stem cell transplantation (HSCT). Participants attended 24 supervised, face-to-face exercise sessions over 8 weeks (3×/week) under physiotherapist supervision. The Experimental Group received game-based exercise using the Nintendo Wii Fit U platform with the Wii Balance Board and the Breathing Labs Breathing Games software (Slovenia) in addition to the conventional program. Outcomes included the Modified Alpha-Fit Pediatric Test Battery (vertical jump, 6-minute walk test, sit-and-reach, flamingo balance), upper-extremity isometric muscle strength (handheld dynamometry) and handgrip strength (Jamar), pulmonary function tests, maximal inspiratory and expiratory mouth pressures, accessory respiratory muscle architecture by myotonometry (MyotonPro: sternocleidomastoid, upper trapezius, pectoralis major), and ultrasound assessment of pleural thickness, diaphragm thickness, and diaphragm excursion.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Hematopoietic Stem Cell Transplantation (HSCT) | — | UNRESOLVED | — |
| Pediatric Physiotherapy | — | UNRESOLVED | — |
| Physiotherapy and Rehabilitation | — | UNRESOLVED | — |
| Pulmonary Rehabilitation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EXERCISE TRAINING WITH OR WITHOUT MEDICATION | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm 1 - Active Comparator: Control Group (CG)
- description
- Conventional pulmonary physiotherapy and rehabilitation program delivered as 24 supervised face-to-face sessions across 8 weeks (3×/week) under physiotherapist supervision. Each session lasted 25 minutes and included diaphragmatic breathing, thoracic expansion exercises (chest and bilateral segmental), incentive spirometry (Triflo® or Voldyne®), postural drainage and percussion, cough technique training, breathing control, and range-of-motion exercises (2 sets × 5 repetitions with 5-6 tidal-breath rest). Intensity targeted Modified Borg Scale 4-6.
- interventionNames
- Other: EXERCISE TRAINING WITH OR WITHOUT MEDICATION
- type
- EXPERIMENTAL
- label
- Arm 2 - Experimental: VR-Assisted Game-Based Exercise + Conventional Physiotherapy (EG)
- description
- Identical conventional pulmonary physiotherapy program PLUS virtual reality-assisted, video game-based exercise delivered concurrently in 24 supervised face-to-face sessions across 8 weeks (3×/week). Game-based component combined the Breathing Labs Breathing Games (5 games with progressive difficulty) and Nintendo Wii Fit U with the Wii Balance Board (8 balance/mobility games; 4 played per session at 5 minutes each). Intensity titrated by Modified Borg Scale (target 4-6).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 5 Years
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Currently receiving care in a pediatric bone marrow transplantation unit (post-HSCT). * Age between 5 and 18 years (inclusive). * Able to perform pursed-lip breathing with expiration ≥ 3 seconds. * Ambulatory and able to cooperate with verbal instructions. * Clinically stable as confirmed by the treating physician at the time of enrollment. * No history of orthopedic, neurological, or cardiac disease. Exclusion Criteria: * Facial palsy. * Severe visual impairment or visual field defects. * Aphasia. * History of abdominal or thoracic surgery. * During study: medically unstable status; new diagnosis of cutaneous graft-versus-host disease (GvHD) requiring high-dose steroid therapy; respiratory-tract or systemic infection requiring isolation; new psychiatric illness with poor prognosis; relocation precluding follow-up; withdrawal of consent.
References
Publications (0)
Data not yet available