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

NCT05131724 | Unknown

• 1 other identifier: VirtWalkCP
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy, Spastic

Keywords

"Rehabilitation"[Mesh]; "Mobility Limitation"[Mesh]; "Virtual Reality"[Mesh]

Outcome Measures

Primary Outcomes (1)

• Functional mobility change

  The 6-Minute Walk Test (6MWT) will be performed according to the recommendations. The test will be performed once in a 10m course layout. Participants will receive standardized instructions and encouragement. The test-retest interclass correlation coefficient of this test is 0.98. The estimated time to perform the test is 10 minutes.

  Basal assessment, at the end of the intervention (an average of 3 weeks), 1 month after the end of the intervention (an average of 8 weeks).

Secondary Outcomes (7)

• Static balance

  Basal assessment, at the end of the intervention (an average of 3 weeks), 1 month after the end of the intervention (an average of 8 weeks)

• Dynamic balance

  Basal assessment, at the end of the intervention (an average of 3 weeks), 1 month after the end of the intervention (an average of 8 weeks)

• Walking speed

  Basal assessment, at the end of the intervention (an average of 3 weeks), 1 month after the end of the intervention (an average of 8 weeks)

• Gross motor function

  Basal assessment, at the end of the intervention (an average of 3 weeks), 1 month after the end of the intervention (an average of 8 weeks)

• Functional independence

  Basal assessment, at the end of the intervention (an average of 3 weeks), 1 month after the end of the intervention (an average of 8 weeks)

Study Arms (2)

Treadmill training

ACTIVE COMPARATOR

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

Virtual reality

EXPERIMENTAL

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

Other: Treadmill training with virtual reality

Interventions

Treadmill training with virtual reality OTHER

The virtual environment will be composed of obstacles, different paths, and narrow and deviated corridors. Walking through this environment will require the infant to coordinate walking behaviour and adjust the length, height, and width of steps to negotiate the obstacles on the television screen placed at the infant's eye level in front of the treadmill. The speed, orientation, size, frequency of appearance, and shape of the obstacles will be manipulated according to individual performance following a standardized protocol. The virtual system will provide visual and auditory feedback on the success or failure of the activity to enhance motor learning. In addition, the characteristics of the environment (e.g., visibility, configuration, and distractions) will be adjusted to increase the complexity of the training.

Virtual reality

Treadmill training OTHER

The RAM870A of the Medisoft treadmill will be used. Two treadmill training sessions will be held before the onset of the intervention to familiarize the children with the equipment. During these two sessions, the treadmill training and speed will be set according to the following procedures: the ground walking speed of each child will be determined through the baseline 6MWT, then the training velocity will be set at 50% of the maximum ground speed established during the 6MWT and increased gradually based on the tolerance of each child (i.e., no complaint of fatigue, heart rate not exceeding 70% of the maximum heart rate, and a lack of gait shuffling, buckling or dragging steps more than 5 seconds during walking).

Treadmill training

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Vic - Central University of Catalonia: lead

Study Sites (1)

Univeristy of Vic - Central University of Catalonia

Vic, Barcelona, 08500, Spain

Location

Related Publications (6)

• Palisano R, Rosenbaum P, Walter S, Russell D, Wood E, Galuppi B. Development and reliability of a system to classify gross motor function in children with cerebral palsy. Dev Med Child Neurol. 1997 Apr;39(4):214-23. doi: 10.1111/j.1469-8749.1997.tb07414.x.

  PMID: 9183258 BACKGROUND

• Novak I, Morgan C, Fahey M, Finch-Edmondson M, Galea C, Hines A, Langdon K, Namara MM, Paton MC, Popat H, Shore B, Khamis A, Stanton E, Finemore OP, Tricks A, Te Velde A, Dark L, Morton N, Badawi N. State of the Evidence Traffic Lights 2019: Systematic Review of Interventions for Preventing and Treating Children with Cerebral Palsy. Curr Neurol Neurosci Rep. 2020 Feb 21;20(2):3. doi: 10.1007/s11910-020-1022-z.

  PMID: 32086598 BACKGROUND

• Chiu HC, Ada L, Bania TA. Mechanically assisted walking training for walking, participation, and quality of life in children with cerebral palsy. Cochrane Database Syst Rev. 2020 Nov 18;11(11):CD013114. doi: 10.1002/14651858.CD013114.pub2.

  PMID: 33202482 BACKGROUND

• Grecco LAC, Hugo P, Sampaio LMM, Oliveira CS. Evidence of the effect of treadmill training on children with cerebral palsy: A systematic review. Clin Exp Med Lett [Internet]. 2012;53(2):95-100. Available from: http://www.ceml-online.com/fulltxt.php?ICID=883582

  BACKGROUND

• Grecco LA, Tomita SM, Christovao TC, Pasini H, Sampaio LM, Oliveira CS. Effect of treadmill gait training on static and functional balance in children with cerebral palsy: a randomized controlled trial. Braz J Phys Ther. 2013 Jan-Feb;17(1):17-23. doi: 10.1590/s1413-35552012005000066.

  PMID: 23538455 BACKGROUND

• Ochandorena-Acha M, Terradas-Monllor M, Nunes Cabrera TF, Torrabias Rodas M, Grau S. Effectiveness of virtual reality on functional mobility during treadmill training in children with cerebral palsy: a single-blind, two-arm parallel group randomised clinical trial (VirtWalkCP Project). BMJ Open. 2022 Nov 3;12(11):e061988. doi: 10.1136/bmjopen-2022-061988.

  PMID: 36328390 DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Mirari Ochandorena-Acha, PhD

  University of Vic - Central University of Catalonia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mirari Ochandorena-Acha, PhD

CONTACT

+34 659 408 555; mirari.ochandorena@uvic.cat

Marc Terradas-Monllor, PhD

CONTACT

+34 652 948 632; marc.terradas@uvic.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: November 1, 2021
• First Posted: November 23, 2021
• Study Start: September 1, 2022
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2025
• Last Updated: November 30, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)