Stop Tip-toeing Around Toe-walking

University Children's Hospital Basel

Status: Completed

Conditions: Spastic Cerebral Palsy (sCP)

Treatments: Diagnostic Test: Dynamic stability measurement; Diagnostic Test: Static stability measurement

Study type: Interventional

Funder types: Other

Identifiers

NCT04879199

2021-00435 ks21Viehweger;

Details and patient eligibility

About

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)

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 7 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Typically Developing (TD) children

Experimental group

Description:

Static stability and Dynamic stability measurement in children with: 1) between the age of 7 and 18 years, 2) who are typically developing, 3) able to stand and walk alone without using assistance or assistive devices, 4) able to place their feet flat on the force platforms, and 5) with enough German language skills to follow the instructions.

Treatment:

Diagnostic Test: Dynamic stability measurement

Diagnostic Test: Static stability measurement

Spastic Cerebral Palsy (sCP) children

Experimental group

Description:

Static stability and Dynamic stability measurement in children with: 1) between the age of 7 and 18 years, 2) 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) \[98\], 3) being able to stand and walk alone without assistance or assistive devices, 4) able to place their feet flat on the force platforms, and 5) with enough German language skills to follow the instructions.

Treatment:

Diagnostic Test: Dynamic stability measurement

Diagnostic Test: Static stability measurement