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Stop Tip-toeing Around Toe-walking

NCT04879199 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2023-10-18

No results posted yet for this study

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)

Conditions

  • Spastic Cerebral Palsy (sCP)

Interventions

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.

Sponsors & Collaborators

  • University Children's Hospital Basel

    lead OTHER

Principal Investigators

  • Heide Elke Viehweger, Prof. Dr. med. · University Children's Hospital Basel, Neuroorthopedics I Human Locomotion Research

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-11
Primary Completion
2023-09-30
Completion
2023-09-30

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04879199 on ClinicalTrials.gov