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Task-Specific Training Approach involving Augmented Reality Games (Interact Protocol) in children with Spastic Cerebral Palsy: a randomized controlled trial

Task-Specific Training in an Augmented Reality Context (Interact Protocol) in children with Spastic Cerebral Palsy: a randomized controlled trial - INTERACT INdividualized and Task-specific training with environmental Enrichment using Real and augmented realities in an ACTive way

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5b6q7vf
Enrollment
Unknown
Registered
2023-12-11
Start date
2024-01-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bilateral spastic cerebral palsy

Interventions

This is a randomized controlled clinical study with two arms, open. Thirty-four children will be included. Experimental group: 17 children aged 6 to 12 years with spastic cerebral palsy will receive i

Sponsors

Universidade Federal de São Carlos
Lead Sponsor
Universidade Federal de São Carlos
Collaborator

Eligibility

Age
6 Years to 12 Years

Inclusion criteria

Inclusion criteria: Children with a medical diagnosis of unilateral and bilateral spastic cerebral palsy; level of GMFCS (Gross Motor Function Classification System) I and II; who walk without walking aids; MACS (Manual Ability Classification System) I, II, and III; with modified Ashworth score from 0 to 1+; aged between 6 and 12 years; who understand simple verbal commands; with mass and height within the normal growth curve

Exclusion criteria

Exclusion criteria: Children who have dystonic, athetoid, or ataxic tonus classification; GMFCS level III, IV and V; MACS IV and V; with modified Ashworth score from 2 to 4 in limbs; with cognitive impairment that may compromise understanding of verbal commands; who receive orthopedic surgical procedures less than a year ago; with application of chemical blockages less than 6 months ago; with physical deformities that prevent or compromise the execution of the proposed activities; with use of medications that may alter strength or muscular tone; visual or auditory sensory deficits without correction with auxiliary devices; cardiorespiratory limitations of any intensity; who have undergone other intensive therapies less than 6 months ago; children that do not like video games

Design outcomes

Primary

MeasureTime frame
Postural control: assessed with a force plate which generates variables of center of pressure (cop) displacement during the standing, functional reaching and sit-to-stand movement; and kinematics analysis during sit-to-stand movement and functional reaching test. It is expected the great reduction in instability in the INTERACT group. This outcome will be assessed before, after and within 2 months after the end of training.

Secondary

MeasureTime frame
Performance Satisfaction: Performance satisfaction will be assessed with the Canadian Occupational Performance Measure. We expect performance satisfaction to improve by 30%. This outcome will be assessed in the first, third and sixth weeks, and after 2 months without INTERACT training. INTERACT means an individualized exercise protocol (IN - individualized); focused on task-specific activities (T - task-specific); with environmental enrichment (E - environment enrichment); using both real and augmented realities (R - real and augmented realities); and performed in an active manner (ACT - active training);Self-reported performance: Self-reported performance will be assessed with the Canadian Occupational Performance Measure. We expect to improve by 30%. This outcome will be assessed in the first, third and sixth weeks, and after 2 months without INTERACT training. INTERACT means an individualized exercise protocol (IN - individualized); focused on task-specific activities (T - task-specific); with environmental enrichment (E - environment enrichment); using both real and augmented realities (R - real and augmented realities); and performed in an active manner (ACT - active training);Motivation: assessed with the Dimensions of Mastery Questionnaire. We expect that motivation will be higher in INTERACT protocol because of the enjoyable characteristics of the training. This outcome will be assessed before, after and within 2 months after the end of training. INTERACT means an individualized exercise protocol (IN - individualized); focused on task-specific activities (T - task-specific); with environmental enrichment (E - environment enrichment); using both real and augmented realities (R - real and augmented realities); and performed in an active manner (ACT - active training);Motor skills: The motor skills will be assessed with the Challenge Module of Gross Motor Function Measure. We expect an improvement in the motor skills in both treatments but higher in INTERA

Countries

Brazil

Contacts

Public ContactBruna Romão-Silva

Universidade Federal de São Carlos

brunars@estudante.ufscar.br+55(11)944729995

Outcome results

None listed

Source: REBEC (via WHO ICTRP)