NCT04879199

Stop Tip-toeing Around Toe-walking

Stop Tip-toeing Around Toe-walking: Towards a Better Understanding and More Effective Treatment of Toe-walkers With Cerebral Palsy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: University Children's Hospital Basel · Academic / Other
• Sex: All
• Age: 7 Years – 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to explore the interplay among nervous-, musculoskeletal-, and psychological systems and how they impact toe-walking behavior, and vice versa. Sub-Project 1 is to analyze the feasibility of the developed virtual reality (VR) environment, in 10 TD and sCP children respectively. It is assess the effects of VR immersion on predefined static and dynamic stability parameters. Sub-Project 2: After adjustments have been made following Sub-Project 1 regarding the study procedure, technical factors or the parameters of interest etc., the optimized study procedure is implemented in Sub-Project 2 (20 to 25 TD will be included). Sub-Project 3: After adjustments have been made following Sub-Project 1 regarding the study procedure, technical factors or the parameters of interest etc., the optimized study procedure is implemented in Sub-Project3 (20 to 25 sCP will be included)

Detailed description

The interplay between the nervous-, musculoskeletal-, and psychological systems and their impact on resulting walking patterns are poorly understood. Children that toe-walk often show poorer levels of static and dynamic stability, leading to a lower quality of life compared to typically develop-ing children (TD). Current research suggests multifactorial adaptations in central and/or peripheral nervous as well as the musculoskeletal system contribute to and result from toe-walk-ing. The purpose of this study is to explore the interplay among nervous-, musculoskeletal-, and psychological systems and how they impact toe-walking behavior, and vice versa. The effect of psychological factors (via the use of a custom-designed virtual reality environment) on static vs. dynamic stability, motor control, coordination (indirect assessment of central nervous system function) as well as reflex control (Hoffmann-reflex, H-reflex, performance of peripheral nervous system) is investigated.

Conditions

• Spastic Cerebral Palsy (sCP)

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Static stability measurement	The child stands barefoot on dual force platforms in two (CP: three) different conditions: barefoot and with shoes (CP: and with orthosis). Each condition is recorded three times each lasting for 30s, and 30s rest between them. Both conditions are recorded with and without wearing a headset. The order of conditions (within each Virtual Reality ("VR)-condition") is randomized. For each condition, the child rests in a comfortable position for 20s with the heels on the same level and arms hanging at their sides. Between both "VR-conditions", the child rests for 120 s.
DIAGNOSTIC_TEST	Dynamic stability measurement	The child walks at their normal walking speed on a 10-m walkway in two (CP: three) different conditions: barefoot and with shoes (CP: and with orthosis). For each condition, at least six error-free trials are recorded. Errors in data may occur due to hidden or lost markers during walking or software interruptions. Both conditions are recorded with and without wearing a headset. The order of conditions (within each "VR-condition") is randomized.

Timeline

• Start date: 2021-08-11
• Primary completion: 2023-09-30
• Completion: 2023-09-30
• First posted: 2021-05-10
• Last updated: 2023-10-18

Locations

1 site across 1 country: Switzerland