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NCT05131724 | Not yet recruiting | Cerebral Palsy, Spastic


Effectiveness of Virtual Reality on Functional Mobility During Treadmill Training in Children With Cerebral Palsy
Sponsor:

University of Vic - Central University of Catalonia

Information provided by (Responsible Party):

Mirari Ochandorena Acha

Brief Summary:

Cerebral palsy (CP), which occurs as a consequence of brain damage, has multiple deficits such as a global reduction of motor cortical activity during movement execution and inadequate processing of corticospinal and somatosensory circuits. Global registers estimate that it occurs in two to three of 1.000 live births, and spasticity is the most common disorder, occurring in 80% of children with CP. Spasticity might affect both upper and lower limbs, resulting in other deficits in joint mobility, postural reactions, selective motor control, balance, and gait. This set of impairments and deficits may lead to limitations in functional ability and autonomy in the performance of daily living activities, physical fitness, quality of life, and/or ability to participate in games and sports activities compared to neurotypical peers of the same age. Walking is considered one of the most important activities in daily life, as it is essential for activities of daily living and social participation. Children with Gross Motor Function Classification System (GMFCS) levels I, II, and III show potential for walking, and around 75% of CP children are ambulatory. However, abnormalities in neural control and muscle weakness contribute to several gait characteristics such as slow velocity, decreased stride length, increased stance phase percentage, and increased peak ankle dorsiflexion and knee flexion, and peak hip extension moments. Consequently, this gait pattern contributes to postural instability and increased fall risk in children with CP, among others.

Condition or disease

Cerebral Palsy, Spastic

Intervention/treatment

Treadmill training with virtual reality

Treadmill training

Phase

Not Applicable

Detailed Description:

The main objective of the present study is to evaluate the effectiveness of treadmill gait training and virtual reality comparing to treadmill gait training on functional mobility in infants with spastic cerebral palsy. The study design is a two-arm randomized clinical trial, single-center and single-blind (evaluators). The sample will be recruited at the Hospital General de Vic, and the study will be conducted at the Universitat de Vic - Universitat Central de Catalunya (UVic-UCC).}}

Study Type : Interventional
Estimated Enrollment : 30 participants
Masking : Single
Primary Purpose : Treatment
Official Title : Effectiveness of Virtual Reality on Functional Mobility During Treadmill Training in Children With Cerebral Palsy: a Randomized Clinical Trial (VirtWalkCP Project)
Actual Study Start Date : September 2022
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : September 2025
Arm Intervention/treatment

Active Comparator: Treadmill training

The treadmill training would be 10 sessions over 2 weeks with 30 minutes for each session (5-min warm-up; 20 min gait training; 5-min cool-down). During the sessions, treadmill speed will be maintained at 60 to 80% of the maximum speed established on an exertion test. The child will walk at 60% maximum speed in the first and final five minutes and 80% in the middle 20 minutes.

Other: Treadmill training

Experimental: Virtual reality

Infants in the TTVR group will perform gait training on the treadmill simultaneously with virtual reality.

Other: Treadmill training with virtual reality

Ages Eligible for Study: 4 Years to 12 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Medical diagnosis of spastic cerebral palsy
  • Motor function levels I to III according to the Gross Motor Function Classification System
  • Independent walking was acquired for more than 12 months.
  • Able to ambulate for at least 10 meters with or without aids.
Exclusion Criteria
  • Orthopaedic surgery on the lower limbs in the past 12 months.
  • Scheduled surgery during the period of the study.
  • Orthopaedic deformities with surgery indication.
  • Uncontrolled seizure disorder.
  • Metallic implant in the skull.
  • Hearing aid.
  • Have received toxic botulin injections in the past 6 months.
  • Significant cognitive or visual impairment.

Effectiveness of Virtual Reality on Functional Mobility During Treadmill Training in Children With Cerebral Palsy

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Effectiveness of Virtual Reality on Functional Mobility During Treadmill Training in Children With Cerebral Palsy

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Locations


Not yet recruiting

Spain, Barcelona

University of Vic - Central University of Catalonia

Vic, Barcelona, Spain, 08500

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