Dataset Information

Physiotherapy-assisted overground exoskeleton use: mixed methods feasibility study protocol quantifying the user experience, as well as functional, neural, and muscular outcomes in children with mobility impairments.

ABSTRACT:

Background

Early phase research suggests that physiotherapy paired with use of robotic walking aids provides a novel opportunity for children with severe mobility challenges to experience active walking. The Trexo Plus is a pediatric lower limb exoskeleton mounted on a wheeled walker frame, and is adjustable to fit a child's positional and gait requirements. It guides and powers the child's leg movements in a way that is individualized to their movement potential and upright support needs, and can provide progressive challenges for walking within a physiotherapy-based motor learning treatment paradigm.

Methods

This protocol outlines a single group mixed-methods study that assesses the feasibility of physiotherapy-assisted overground Trexo use in school and outpatient settings during a 6-week physiotherapy block. Children ages 3-6 years (n = 10; cerebral palsy or related disorder, Gross Motor Function Classification System level IV) will be recruited by circle of care invitations to participate. Study indicators/outcomes will focus on evaluation of: (i) clinical feasibility, safety, and acceptability of intervention; (ii) pre-post intervention motor/functional outcomes; (iii) pre-post intervention brain structure characterization and resting state brain connectivity; (iv) muscle activity characterization during Trexo-assisted gait and natural assisted gait; (v) heart rate during Trexo-assisted gait and natural assisted gait; and (vi) user experience and perceptions of physiotherapists, children, and parents.

Discussion

This will be the first study to investigate feasibility indicators, outcomes, and experiences of Trexo-based physiotherapy in a school and outpatient context with children who have mobility challenges. It will explore the possibility of experience-dependent neuroplasticity in the context of gait rehabilitation, as well as associated functional and muscular outcomes. Finally, the study will address important questions about clinical utility and future adoption of the device from the physiotherapists' perspective, comfort and engagement from the children's perspective, and the impressions of parents about the value of introducing this technology as an early intervention.

Clinical trial registration

https://clinicaltrials.gov, identifier NCT05463211.

SUBMITTER: Bradley SS

PROVIDER: S-EPMC11322617 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Physiotherapy-assisted overground exoskeleton use: mixed methods feasibility study protocol quantifying the user experience, as well as functional, neural, and muscular outcomes in children with mobility impairments.

Bradley Stefanie S SS de Holanda Ledycnarf Januario LJ Chau Tom T Wright F Virginia FV

Frontiers in neuroscience 20240731

<h4>Background</h4>Early phase research suggests that physiotherapy paired with use of robotic walking aids provides a novel opportunity for children with severe mobility challenges to experience active walking. The Trexo Plus is a pediatric lower limb exoskeleton mounted on a wheeled walker frame, and is adjustable to fit a child's positional and gait requirements. It guides and powers the child's leg movements in a way that is individualized to their movement potential and upright support need ...[more]

PMID: 39145294

Similar Datasets

Project description:BackgroundEvidence is emerging for the use of overground lower limb robotic exoskeletons in the rehabilitation of people with spinal cord injury (SCI), with suggested benefits for gait speed, bladder and bowel function, pain management and spasticity. To date, research has focused on devices that require the user to support themselves with a walking aid. This often precludes use by those with severe trunk, postural or upper limb deficits and places the user in a suboptimal, flexed standing position. Free-standing exoskeletons enable people with higher level injuries to exercise in an upright position. This study aimed to evaluate the feasibility of therapy with a free-standing exoskeleton for those with SCI, and to determine the potential health-related benefits of this intervention.MethodsThis 12-week intervention study with 12-week waitlist control and 12-week follow up, provided people with SCI scoring < 5 on the mobility section of the spinal cord independence measure (SCIM-III) twice weekly therapy in the REX (Rex Bionics, Auckland, NZ), a free-standing lower limb robotic exoskeleton. The primary outcome measure of interest was function, as measured on the SCIM-III. A battery of secondary outcomes was included. Participants also completed a survey on their perceptions of this treatment modality, to determine acceptability.ResultsForty-one potential participants were screened for eligibility. Two females (one ASIA A, one ASIA C) and one male (ASIA B) completed all 24 intervention sessions, and the follow up assessment. One participant showed positive trends in function, fatigue, quality of life and mood during the intervention phase. Grip and quadriceps strength, and lower limb motor function improved in another. Two improved their percentage of lean body mass during the intervention phase. Remaining results were varied across patients, time points and outcomes. The intervention was highly acceptable to all participants.ConclusionWith three of 41 potential participants being eligible and completing this study, our results show that there are potential benefits of exercise in a free-standing exoskeleton for people with severe mobility impairment due to SCI, for a small subset of patients. Further research is warranted to determine those most likely to benefit, and the type of benefit depending on the patient characteristics. Trial registration The trial was registered prospectively on 20 April 2018 at www.anzctr.org.au/ (ACTRN12618000626268).

Project description:ObjectivesHome-based physiotherapy interventions to improve post-stroke mobility are successful in high-income countries. These programs require less resources compared to center-based programs. However, feasibility of such an intervention in a low and middle-income setting remains unknown. Therefore, the SunRISe (Stroke Rehabilitation In Suriname) study aimed to assess feasibility and preliminary effectiveness of a home-based semi-supervised physiotherapy intervention to promote post-stroke mobility in a low resource setting.DesignProspective randomized controlled trial.MethodsChronic stroke patients were recruited and randomized into either an intervention group (IG (N = 20)) or a control group (CG (N = 10)). The IG received a 3-days-a-week home-based physiotherapy program that was supervised in the first 4 weeks and tele-supervised during the second 4 weeks. The physiotherapy program consisted of walking as well as functional and mobilization exercises. The CG received usual care. Feasibility outcome measures included adherence, patient satisfaction and safety. Efficacy measures included functional exercise tolerance (six-minute walking test (6MWT), functional balance (Berg Balance Score (BBS), upper extremity (UE) function (Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire), and UE strength ((non-)paretic handgrip (HG) strength). Two-way analysis of variance was used for data analysis.ResultsThirty participants (61.8 ± 9.2 years old, 13 men) were enrolled in the study. The intervention was completed by 14 participants (70%). Adherence was affected by rainy season associated infrastructural problems (n = 2), the medical status of participants (n = 3) and insufficient motivation to continue the program without direct supervision (n = 1). No adverse events were noted and participants were satisfied with the program. Functional exercise tolerance (57.2 ± 67.3m, p = 0.02) and UE function (-9.8 ± 15.2, p = 0.04) improved in the IG compared to no change in the CG. HG strength was unaltered and a ceiling effect occurred for BBS.ConclusionOur home-based semi-supervised physiotherapy intervention seems safe, associated with moderate to high levels of engagement and patient satisfaction and results in functional improvements.

Project description:BackgroundRobotic assisted gait training (RAGT) uses a powered exoskeleton to support an individual's body and move their limbs, with the aim of activating latent, pre-existing movement patterns stored in the lower spinal cord called central pattern generators (CPGs) to facilitate stepping. The parameters that directly stimulate the stepping CPGs (hip extension and ipsilateral foot unloading) should be targeted to maximise the rehabilitation benefits of these devices.AimTo compare the biomechanical profiles of individuals with a spinal cord injury (SCI) and able-bodied individuals inside the ReWalkTM powered exoskeleton and to contrast the users' profiles with the exoskeleton.MethodsEight able-bodied and four SCI individuals donned a ReWalkTM and walked along a 12-meter walkway, using elbow crutches. Whole-body kinematics of the users and the ReWalkTM were captured, along with GRF and temporal-spatial characteristics. Discreet kinematic values were analysed using a Kruskall-Wallis H and Dunn's post-hoc analysis. Upper-body differences, GRF and temporal-spatial characteristics were analysed using a Mann-Whitney U test (P<0.05).ResultsWalking speed ranged from 0.32-0.39m/s. Hip abduction, peak knee flexion and ankle dorsiflexion for both the SCI and able-bodied groups presented with significant differences to the ReWalkTM. The able-bodied group presented significant differences to the ReWalkTM for all kinematic variables except frontal plane hip ROM (P = 0.093,δ = -0.56). Sagittal plane pelvic and trunk ROM were significantly greater in the SCI vs. able-bodied (P = 0.004,δ = -1; P = 0.008,δ = -0.94, respectively). Posterior braking force was significantly greater in the SCI group (P = 0.004, δ = -1).DiscussionThe different trunk movements used by the SCI group and the capacity for the users' joint angles to exceed those of the device suggest that biomechanical profiles varied according to the user group. However, upright stepping with the ReWalkTM device delivered the appropriate afferent stimulus to activate CPGs as there were no differences in key biomechanical parameters between the two user groups.

Dataset Information

Physiotherapy-assisted overground exoskeleton use: mixed methods feasibility study protocol quantifying the user experience, as well as functional, neural, and muscular outcomes in children with mobility impairments.

Background

Methods

Discussion

Clinical trial registration

Publications

Physiotherapy-assisted overground exoskeleton use: mixed methods feasibility study protocol quantifying the user experience, as well as functional, neural, and muscular outcomes in children with mobility impairments.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets