CompletedNot Applicable

Virtual Reality-Assisted Exercise in Pediatric Hematopoietic Stem Cell Transplantation

Turkey (Türkiye)38 participantsStarted 2025-01-16

Plain-language summary

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.

Who can participate

Age range

5 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Vertical Jump Test

Timeframe: Baseline to Week 8

Diaphragm Ultrasound

Timeframe: Baseline to Week 8

Trial details

NCT IDNCT07653880

SponsorIstinye University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-30

View on ClinicalTrials.gov More Hematopoietic Stem Cell Transplantation (HSCT) trials