Clinical trial NCT04879199: Stop Tip-toeing Around Toe-walking
Official title: Stop Tip-toeing Around Toe-walking: Towards a Better Understanding and More Effective Treatment of Toe-walkers With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spastic Cerebral Palsy (sCP)
Keywords: tip-toeing
toe-walking
gait cycle
heel-strike
Static stability
Dynamic stability
Virtual Reality
Cerebral Palsy (CP)
Lead sponsor: University Children's Hospital Basel
Sponsor class: OTHER
First posted: 2021-05-10
Enrollment: 46
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cross sectional, age-matched-controlled and monocentric study with an exploratory approach.
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: Inclusion Criteria for TD children:

* between the age of 7 and 18 years
* who are typically developing
* able to stand and walk alone without using assistance or assistive devices
* able to place their feet flat on the force platforms
* with enough German language skills to follow the instructions

Inclusion Criteria for sCP children:

* between the age of 7 and 18 years
* with the diagnosis of spastic CP or CP similar (both unilateral and bilateral), functionally classified level I or II according to the Gross Motor Function Classification System (GMFCS)
* being able to stand and walk alone without assistance or assistive devices
* able to place their feet flat on the force platforms
* with enough German language skills to follow the instructions

Exclusion Criteria for TD children:

* severe visual, cognitive, or auditory impairments that would interfere with the study instructions and the VR immersion
* any vestibular problems (e.g. severe motion sickness)
* history of epilepsy, pace-marker or/and electrical pumps (due to possible interference with electrical stimulation)
* prior experience of VR to ensure a comparable baseline between subjects

Exclusion Criteria for sCP children:

* severe visual, cognitive, or auditory impairments that would interfere with the study instructions and the VR immersion
* severe knee flexion gait (\>45°)
* walking capacity \<50m
* botulinum toxin type A treatment (past 6 months)
* orthopedic surgery of upper or lower extremities (past 12 months)
* any vestibular problems (e.g. severe motion sickness or dizziness)
* history of epilepsy, pace-marker or/and electrical pumps (due to possible interference with electrical stimulation)
* prior experience of VR as they may already be adapted to VR.

Primary outcomes:
measure: Static stability assessed by Center of Pressure (COP) shifts in anterior-posterior and mediolateral directions under each limb
timeFrame: one time assessment at baseline (complete baseline assessments up to 3 hours)
measure: Static stability assessed by Visual Analogue Scale (VAS)
timeFrame: one time assessment at baseline (complete baseline assessments up to 3 hours)
measure: Static stability assessed by Ratio between H-reflex and M-wave amplitude
timeFrame: one time assessment at baseline (complete baseline assessments up to 3 hours)
measure: Dynamic stability assessed by COP shifts in combination with base of support trajectory
timeFrame: one time assessment at baseline (complete baseline assessments up to 3 hours)
measure: Dynamic stability assessed by number of muscle synergies
timeFrame: one time assessment at baseline (complete baseline assessments up to 3 hours)
measure: Dynamic stability assessed by interlimb coordination
timeFrame: one time assessment at baseline (complete baseline assessments up to 3 hours)
measure: Dynamic stability assessed by Self-perceived degree of safety during walking in the VR environment using a Visual Analogue Scale (VAS)
timeFrame: one time assessment at baseline (complete baseline assessments up to 3 hours)
Secondary outcomes:
measure: Dynamic stability measurement assessed by kinematic data of upper & lower extremities (joint angles in degree)
timeFrame: one time assessment at baseline (complete baseline assessments up to 3 hours)
measure: Dynamic stability measurement assessed by spatiotemporal parameters: walking speed (normalized to leg length) [m/(s*mm)]
timeFrame: one time assessment at baseline (complete baseline assessments up to 3 hours)
measure: Dynamic stability measurement assessed by spatiotemporal parameters: stride width [s]
timeFrame: one time assessment at baseline (complete baseline assessments up to 3 hours)
measure: Dynamic stability measurement assessed by spatiotemporal parameters: double support time [s]
timeFrame: one time assessment at baseline (complete baseline assessments up to 3 hours)
measure: Dynamic stability measurement assessed by spatiotemporal parameters: cadence [steps/min]
timeFrame: one time assessment at baseline (complete baseline assessments up to 3 hours)
measure: Dynamic stability measurement assessed by spatiotemporal parameters: step length [m]
timeFrame: one time assessment at baseline (complete baseline assessments up to 3 hours)
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Children's Hospital Basel, Neuroorthopedics I Human Locomotion Research
Study officials:
affiliation: University Children's Hospital Basel, Neuroorthopedics I Human Locomotion Research
name: Heide Elke Viehweger, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: