Virtual Reality Combined With Bobath Therapy for Spastic Cerebral Palsy

Официальное название

Effects of Virtual Reality Combined With Bobath Technique on Lower Limb Muscle Activity, Balance, and Motor Function in Patients With Spastic Cerebral Palsy: A Randomized Controlled Trial

Обзор

Spastic cerebral palsy is a common neurodevelopmental disorder characterized by increased muscle tone, impaired balance, and limitations in motor function, particularly in the lower limbs. Conventional rehabilitation approaches such as the Bobath technique are widely used to improve posture control and movement patterns; however, patient engagement and task variability may be limited. This randomized controlled trial aims to evaluate the effectiveness of virtual reality (VR) combined with Bobath therapy on lower limb muscle activity, balance, and gross motor function in patients with spastic cerebral palsy. Eligible participants will be randomly assigned to either a VR plus Bobath intervention group or a conventional Bobath therapy group. The intervention will be delivered over a 6-week period, with sessions conducted five times per week. Outcome measures, including surface electromyography (sEMG), center of pressure (COP) parameters, and the Gross Motor Function Measure-88 (GMFM-88), will be assessed before and after the intervention. This study seeks to provide evidence on whether integrating VR into conventional rehabilitation can improve functional outcomes in children with spastic cerebral palsy.

Подробное описание

This study is a prospective, single-center, randomized controlled trial designed to investigate the effects of virtual reality (VR) combined with Bobath therapy on lower limb muscle activity, balance, and motor function in patients with spastic cerebral palsy.

Participants aged 2 to 14 years who are diagnosed with spastic diplegic or hemiplegic cerebral palsy and classified as Gross Motor Function Classification System (GMFCS) levels I to III will be recruited. Eligible participants will be randomly allocated in a 1:1 ratio to either the experimental group or the control group.

The experimental group will receive immersive, task-oriented VR training combined with Bobath neurodevelopmental therapy. The control group will receive conventional Bobath-based rehabilitation without VR components. Both groups will undergo training sessions lasting 40 minutes per session, five sessions per week, for a total duration of 6 weeks. All interventions will be delivered by experienced physical therapists.

Primary outcomes include lower limb muscle activity assessed by surface electromyography (sEMG) of the rectus femoris, biceps femoris, tibialis anterior, and soleus muscles; balance performance evaluated using center of pressure (COP) parameters; and gross motor function measured by the Gross Motor Function Measure-88 (GMFM-88), specifically dimensions D (standing) and E (walking, running, and jumping). Assessments will be conducted at baseline and immediately after completion of the intervention period.

Secondary outcomes may include measures of participation and quality of life. Data will be analyzed using appropriate statistical methods, including repeated measures analysis of variance and covariance analysis, with a significance level set at p \< 0.05.

This study aims to provide clinical evidence regarding the potential benefits of integrating virtual reality into conventional Bobath therapy for lower limb rehabilitation in children with spastic cerebral palsy.

Вмешательства

• Поведенческое Virtual Reality Combined With Bobath Therapy
  Immersive, task-oriented virtual reality training integrated with Bobath neurodevelopmental therapy, delivered by trained physical therapists. Each session will last 40 minutes and will be conducted five times per week for a total duration of 6 weeks.
• Поведенческое Conventional Bobath Therapy
  Standard Bobath-based neurodevelopmental therapy provided by experienced physical therapists, without the use of virtual reality. Sessions will last 40 minutes and will be conducted five times per week for a total duration of 6 weeks.

Первичные конечные точки

• Lower Limb Muscle Activity Assessed by Surface Electromyography [Срок оценки: Baseline and immediately after 6 weeks of intervention]
• Balance Function Assessed by Center of Pressure Parameters [Срок оценки: Baseline and immediately after 6 weeks of intervention]
• Gross Motor Function Measured by the Gross Motor Function Measure-88 [Срок оценки: Baseline and immediately after 6 weeks of intervention]

Вторичные конечные точки (4)

• Overall Quality of Life Score Assessed by PedsQL Total Score [Срок оценки: Baseline and immediately after 6 weeks of intervention]
• Domain-Specific Quality of Life Scores Assessed by PedsQL [Срок оценки: Baseline and immediately after 6 weeks of intervention]
• Attendance Rate of Scheduled Rehabilitation Sessions [Срок оценки: Throughout the 6-week intervention period]
• Completion Rate of the Rehabilitation Program [Срок оценки: Throughout the 6-week intervention period]

Критерии участия

Критерии включения

• Aged 2 to 14 years at the time of enrollment.
• Diagnosed with spastic cerebral palsy (spastic diplegia or spastic hemiplegia) by a qualified clinician.
• Classified as Gross Motor Function Classification System (GMFCS) levels I to III.
• Presence of lower limb spasticity with a Modified Ashworth Scale (MAS) score of at least 1.
• Ability to understand and follow simple instructions appropriate for age and cognitive level.
• Written informed consent obtained from a parent or legal guardian.

Критерии исключения

• Presence of severe cognitive impairment that prevents participation in the intervention or assessments.
• Uncontrolled epilepsy or a history of frequent seizures that may interfere with the intervention.
• Severe visual, vestibular, or auditory impairments that limit safe participation in virtual reality training.
• Orthopedic surgery or botulinum toxin injection involving the lower limbs within the previous 6 months.
• Participation in other interventional clinical studies during the study period.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Hongxinkang New Traditional Chinese Medicine Hospital, Tongren — Tongren

Идентификаторы

NCT: NCT07392398 · THKTCMH-VR-BOBATH-CP-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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