Effect of Task-Specific Training in an Augmented Reality Context on Upper Limb Function and Activities in Children With Spastic Cerebral Palsy

NCT06571929 | Recruiting

• 1 other identifier: Interventional
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Children with Cerebral Palsy (CP), a condition that affects movement and coordination, face difficulties in daily activities such as dressing, reaching for objects in high places, and getting up from seats. These challenges can negatively impact the quality of life for these children. Therefore, it is essential to seek effective treatments that help improve these skills. The use of technology in treatments, especially with games that utilize augmented reality (AR), has proven to be a good strategy. This technique aids motor learning, improving the skills that children struggle with while also increasing motivation, allowing them to engage in activities they enjoy. However, the application of AR in children with CP is still limited. In this context, it is crucial to provide appropriate treatments for these children, harnessing the benefits of AR technology. This study aims to investigate the effects of a protocol called "INTERACT protocol," which consists of training activities that interest children, such as reaching for objects and getting up from a bench. These activities are linked to AR games and will be conducted with accessible equipment for children with CP, aiming to improve their quality of life. The children selected for the research will be divided into two groups: the experimental group (INTERACT) and the control group. This division will be done by random draw. The children in the control group will continue receiving the physiotherapy they are already undergoing for the same duration as the children in the INTERACT group. All children will participate in the treatment for 4 weeks, three times a week, with sessions lasting 1 hour and 20 minutes each. Our hypothesis is that the children participating in the INTERACT protocol will show improvements in activities involving reaching for objects and in the transition from sitting to standing.

Conditions

Cerebral Palsy, Spastic

Keywords

Cerebral Palsy; Children; Games; Augmented reality

Outcome Measures

Primary Outcomes (3)

• Kinematic assessment of manual reach

  Data collection of reach movement will be conducted using the OpenCap software, which combines computer vision and musculoskeletal simulation to quantify human movement kinematics from videos captured using iPhones.

  Initial assessment (two days before the intervention); final assesment (maximum five days after the intervention);retention phase assessment (two months after the end of the intervention).

• Disabilities of the Arm, Shoulder and Hand (DASH)

  This questionnaire measures physical disability and symptoms in single or multiple upper limb disorders. The DASH requires that the participant answers the questions based on their perceived condition from the previous week. If the participant did not have the opportunity to perform any of the activities in the questionnaire, they are instructed to estimate which response would be the most accurate. It does not matter which hand or arm is used to perform the activity; the questions should be answered based on the ability, regardless of how the task is performed. Participants must respond by circling the answers from 1 to 5, where 1 = there was no difficulty and 5 = could not do it. The higher the score, the greater the motor inability to perform daily activities involving upper limbs.

  Initial assessment (two days before the intervention); final assesment (maximum five days after the intervention);retention phase assessment (two months after the end of the intervention).

• Assessment of postural sway during the sit-to-stand movement and during functional reach in standing position

  These analyses will be performed using the force platform. Sitting to standing analysis: the child will be positioned on a height-adjustable bench with the knees, ankles and hips at a 90º angle, the upper limbs crossed and supported on the chest and the feet on the force platform in a symmetrical manner. Functional reach: on the force platform, with the lower limbs aligned at hip width, and the child should reach as far as possible, moving the center of mass forward, without taking the feet off the platform and with the shoulders flexed at 90º.

  Initial assessment (two days before the intervention); final assesment (maximum five days after the intervention);retention phase assessment (two months after the end of the intervention).

Secondary Outcomes (5)

• The Canadian Occupational Performance Measure (COPM)

  Initial assessment (two days before the intervention); final assessment (maximum five days after the intervention)

• Goal Attainment Scaling (GAS)

  Initial assessment (two days before the intervention); intermediate assessment (after two weeks of training);final assessment (maximum five days after the intervention).

• Pediatric Evaluation of Disability Inventory (PEDI - CAT)

  Initial assessment (two days before the intervention); final assesment (maximum five days after the intervention);retention phase assessment (two months after the end of the intervention).

• Challenge Test

  Initial assessment (two days before the intervention); final assesment (maximum five days after the intervention);retention phase assessment (two months after the end of the intervention).

• Dimensions of Mastery Questionnaire (DMQ)

  Initial assessment (two days before the intervention); final assesment (maximum five days after the intervention);retention phase assessment (two months after the end of the intervention).

Study Arms (2)

Group INTERACT

EXPERIMENTAL

The INTERACT group will participate in an intervention with augmented reality games. During the games, participants will perform hand and arm movements, as well as activities such as sitting and standing up from a chair or climbing and descending steps. The augmented reality software to be used, BRAINN\_XR, includes games such as puzzles and ping pong. The intervention will be conducted by physiotherapists trained in the use of the software. The sessions will take place three times a week, lasting 1 hour and 20 minutes, over a total period of 4 weeks.

Other: INTERACT

Control group

NO INTERVENTION

Interventions

INTERACT OTHER

INTERACT is an individualized, task-specific training program that includes environmental enrichment, natural and augmented realities, and active training.

Group INTERACT

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• In the experimental and control groups, children who have been medically diagnosed with cerebral palsy, either unilateral or bilateral, with spasticity classification, will be included.
• Participants must be classified at GMFCS levels I and II, meaning they are capable of walking independently.
• The MACS (Manual Ability Classification System) should be between levels I (manipulates objects easily), II (manipulates most objects with reduced quality and speed), and III (manipulates objects with difficulty).
• The modified Ashworth score should be between 0 and 2.
• Ability to understand verbal commands and good comprehension of the proposed games.

You may not qualify if:

• Children with dystonic tone classification (identified by the Hypertonia Assessment Tool (HAT)), athetoid, or ataxic.
• GMFCS levels III, IV, and V.
• MACS levels IV and V.
• Modified Ashworth score of 3 to 4.
• Undergoing orthopedic surgical procedures within the past year.
• Receiving chemical blocks within the last 6 months.
• Deformities (muscle shortening and/or loss of joint mobility in the upper limbs) that prevent or compromise the ability to reach the midline.
• Presence of visual and/or auditory sensory deficits not corrected with devices.
• Use of medications that may alter muscle strength or tone.
• Cardiovascular limitations of any intensity, such as excessive fatigue, low exercise tolerance.
• Children who have undergone other intensive therapies within the past 6 months.
• Children with cognitive impairment indicated by caregivers or perceived by researchers due to difficulties in understanding verbal commands and virtual reality games.
• Children who do not accept playing augmented reality games.

Sponsors & Collaborators

• Universidade Federal de Sao Carlos: lead

Study Sites (1)

Federal University of São Carlos (UFSCar)

São Carlos, São Paulo, 13565-905, Brazil

RECRUITING

Related Publications (7)

• McIntyre S, Goldsmith S, Webb A, Ehlinger V, Hollung SJ, McConnell K, Arnaud C, Smithers-Sheedy H, Oskoui M, Khandaker G, Himmelmann K; Global CP Prevalence Group*. Global prevalence of cerebral palsy: A systematic analysis. Dev Med Child Neurol. 2022 Dec;64(12):1494-1506. doi: 10.1111/dmcn.15346. Epub 2022 Aug 11.

  PMID: 35952356 BACKGROUND

• Alrashidi M, Wadey CA, Tomlinson RJ, Buckingham G, Williams CA. The efficacy of virtual reality interventions compared with conventional physiotherapy in improving the upper limb motor function of children with cerebral palsy: a systematic review of randomised controlled trials. Disabil Rehabil. 2023 Jun;45(11):1773-1783. doi: 10.1080/09638288.2022.2071484. Epub 2022 May 16.

  PMID: 35575755 BACKGROUND

• Malick WH, Butt R, Awan WA, Ashfaq M, Mahmood Q. Effects of Augmented Reality Interventions on the Function of Upper Extremity and Balance in Children With Spastic Hemiplegic Cerebral Palsy: A Randomized Clinical Trial. Front Neurol. 2022 Jun 21;13:895055. doi: 10.3389/fneur.2022.895055. eCollection 2022.

  PMID: 35800080 BACKGROUND

• Malick WH, Butt R, Awan WA, Ashfaq M, Mahmood Q. Effects of Augmented Reality Intervention on the Range of Motion and Muscle Strength of Upper Extremity in Children with Spastic Hemiplegic Cerebral Palsy: A Randomized Clinical Trial. Games Health J. 2022 Jun;11(3):168-176. doi: 10.1089/g4h.2021.0128. Epub 2022 Mar 14.

  PMID: 35285674 BACKGROUND

• Jackman M, Sakzewski L, Morgan C, Boyd RN, Brennan SE, Langdon K, Toovey RAM, Greaves S, Thorley M, Novak I. Interventions to improve physical function for children and young people with cerebral palsy: international clinical practice guideline. Dev Med Child Neurol. 2022 May;64(5):536-549. doi: 10.1111/dmcn.15055. Epub 2021 Sep 21.

  PMID: 34549424 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

• Levin MF, Demers M. Motor learning in neurological rehabilitation. Disabil Rehabil. 2021 Dec;43(24):3445-3453. doi: 10.1080/09638288.2020.1752317. Epub 2020 Apr 22.

  PMID: 32320305 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Luana Gonçalves

CONTACT

(35) 98401-9229; luanapo@estudante.ufscar.br

Nelci Adriana Rocha

CONTACT

(16) 99449-4884; acicuto@ufscar.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study will be single-blind, meaning that the evaluator will not know the group to which the participant is assigned. Additionally, in the statistical analysis, the examiner will also remain blind regarding the type of intervention, referring to them as intervention 1 and intervention 2. However, the participants will not be blind to the treatments, due to the impossibility of blinding the type of intervention they will receive.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd student

Model Details: Group control and experimental group

Study Record Dates

• First Submitted: July 20, 2024
• First Posted: August 26, 2024
• Study Start: May 21, 2024
• Primary Completion: July 3, 2024
• Study Completion (Estimated): November 1, 2026
• Last Updated: August 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: The data will only be available once accepted for publication. The articles will be submitted for journal review at the end of 2024

Locations

BR (1)