Virtual Reality-Assisted Exercise in Pediatric Hematopoietic Stem Cell Transplantation

NCT07653880 | Completed

• 1 other identifier: 2024-KAEK-32///01/2025 K-08
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hematopoietic Stem Cell Transplantation (HSCT); Pediatric Physiotherapy; Pulmonary Rehabilitation; Physiotherapy and Rehabilitation; Cancer

Keywords

Hematopoietic Stem Cell Transplantation (HSCT); Pediatric Physiotherapy; Pulmonary Rehabilitation; Exergaming; Physiotherapy and Rehabilitation

Outcome Measures

Primary Outcomes (2)

• Vertical Jump Test

  Component of the Modified Alpha-Fit Pediatric Test Battery. Participant first reaches the maximum standing-reach height with one arm, then jumps vertically to the maximum reachable height; the difference between the two marks is recorded in centimeters. The best of two trials is retained. Higher values indicate greater lower-extremity power. Safety Issue: No.

  Baseline to Week 8

• Diaphragm Ultrasound

  Right-hemidiaphragm thickness measured at end-expiration in the 9th intercostal space (anterior axillary line) using B-mode ultrasonography with a 7 MHz transducer (Toshiba Aplio XG, Tokyo, Japan). Right-hemidiaphragm excursion measured by M-mode with a 3.5 MHz curved-array transducer during quiet breathing, deep breathing, and sniff testing. Mean of three respiratory cycles reported in millimeters. Left hemidiaphragm not assessed due to image-quality limitations.

  Baseline to Week 8

Secondary Outcomes (9)

• Six-Minute Walk Test

  Baseline to Week 8

• Sit-and-Reach Test

  Baseline to Week 8

• Flamingo Balance Test

  Baseline to Week 8

• Upper-Extremity Isometric Muscle Strength

  Baseline to Week 8

• Handgrip Strength

  Baseline to Week 8

Study Arms (2)

Arm 1 - Active Comparator: Control Group (CG)

ACTIVE COMPARATOR

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.

Other: EXERCISE TRAINING WITH OR WITHOUT MEDICATION

Arm 2 - Experimental: VR-Assisted Game-Based Exercise + Conventional Physiotherapy (EG)

EXPERIMENTAL

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).

Other: EXERCISE TRAINING WITH OR WITHOUT MEDICATION

Interventions

EXERCISE TRAINING WITH OR WITHOUT MEDICATION OTHER

Physiotherapist-led pulmonary rehabilitation program (24 sessions; 3×/week × 8 weeks). Components: diaphragmatic breathing, thoracic expansion exercises, incentive spirometry, postural drainage with percussion, cough techniques, breathing control, and range-of-motion exercises. Intensity titrated by Modified Borg Scale (target 4-6).

Arm 1 - Active Comparator: Control Group (CG); Arm 2 - Experimental: VR-Assisted Game-Based Exercise + Conventional Physiotherapy (EG)

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istinye University: lead
• Health Institutes of Turkey: collaborator

Study Sites (1)

Istinye University

Istanbul, 34010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Exercise; Dosage Forms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor was blinded to group allocation. Participants and treating physiotherapists were not blinded due to the nature of the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor; PhD

Model Details: Parallel Assignment Randomized Controlled Single-Blind Trial with parallel allocation; stratified by gender.

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: June 17, 2026
• Study Start: January 16, 2025
• Primary Completion: August 30, 2025
• Study Completion: September 15, 2025
• Last Updated: June 17, 2026

Record last verified: 2026-06

Locations

TU (1)