Stop Tip-toeing Around Toe-walking

NCT04879199 | Completed

• 1 other identifier: 2021-00435; ks21Viehweger
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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)

Conditions

Spastic Cerebral Palsy (sCP)

Keywords

tip-toeing; toe-walking; gait cycle; heel-strike; Static stability; Dynamic stability; Virtual Reality; Cerebral Palsy (CP)

Outcome Measures

Primary Outcomes (7)

• Static stability assessed by Center of Pressure (COP) shifts in anterior-posterior and mediolateral directions under each limb

  COP shifts in anterior-posterior and mediolateral directions under each limb are assessed via the use of two force plates embedded in the floor (Kistler Instrumente AG, Winterthur, Switzerland, sample rate 1500 Hz) (mean value of three repetitions)

  one time assessment at baseline (complete baseline assessments up to 3 hours)

• Static stability assessed by Visual Analogue Scale (VAS)

  Self-perceived degree of safety during walking in the VR environment will be assessed using a Visual Analogue Scale (VAS) ranging from 0 ("feeling completely safe") to 10 ("feeling completely unsafe")

  one time assessment at baseline (complete baseline assessments up to 3 hours)

• Static stability assessed by Ratio between H-reflex and M-wave amplitude

  Ratio between H-reflex and M-wave amplitude, measured through soleus muscle in affected side of hemiplegic sCP and in none-dominant side for diplegic CP and TD (recruitment curve of the H-reflex and the M-wave of the Soleus elicited by stimulating the tibial nerve while standing)

  one time assessment at baseline (complete baseline assessments up to 3 hours)

• Dynamic stability assessed by COP shifts in combination with base of support trajectory

  COP shifts in combination with base of support trajectory assessed via the use of four force plates embedded in the floor (mean value of three repetitions)

  one time assessment at baseline (complete baseline assessments up to 3 hours)

• Dynamic stability assessed by number of muscle synergies

  Number of muscle synergies assessed via the use of a sixteen-channel surface electromyography system

  one time assessment at baseline (complete baseline assessments up to 3 hours)

• Dynamic stability assessed by interlimb coordination

  Interlimb coordination will be calculated by using kinematic data from lower and upper extremities

  one time assessment at baseline (complete baseline assessments up to 3 hours)

• Dynamic stability assessed by Self-perceived degree of safety during walking in the VR environment using a Visual Analogue Scale (VAS)

  Dynamic stability assessed by Self-perceived degree of safety during walking in the VR environment using a Visual Analogue Scale (VAS) ranging from 0 ("feeling completely safe") to 10 ("feeling completely unsafe")

  one time assessment at baseline (complete baseline assessments up to 3 hours)

Secondary Outcomes (6)

• Dynamic stability measurement assessed by kinematic data of upper & lower extremities (joint angles in degree)

  one time assessment at baseline (complete baseline assessments up to 3 hours)

• Dynamic stability measurement assessed by spatiotemporal parameters: walking speed (normalized to leg length) [m/(s*mm)]

  one time assessment at baseline (complete baseline assessments up to 3 hours)

• Dynamic stability measurement assessed by spatiotemporal parameters: stride width [s]

  one time assessment at baseline (complete baseline assessments up to 3 hours)

• Dynamic stability measurement assessed by spatiotemporal parameters: double support time [s]

  one time assessment at baseline (complete baseline assessments up to 3 hours)

• Dynamic stability measurement assessed by spatiotemporal parameters: cadence [steps/min]

  one time assessment at baseline (complete baseline assessments up to 3 hours)

Study Arms (2)

Typically Developing (TD) children

EXPERIMENTAL

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.

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

Spastic Cerebral Palsy (sCP) children

EXPERIMENTAL

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.

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

Interventions

Static stability measurement DIAGNOSTIC_TEST

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.

Spastic Cerebral Palsy (sCP) children; Typically Developing (TD) children

Dynamic stability measurement DIAGNOSTIC_TEST

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.

Spastic Cerebral Palsy (sCP) children; Typically Developing (TD) children

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• University Children's Hospital Basel: lead

Study Sites (1)

University Children's Hospital Basel, Neuroorthopedics I Human Locomotion Research

Basel, 4056, Switzerland

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Heide Elke Viehweger, Prof. Dr. med.

  University Children's Hospital Basel, Neuroorthopedics I Human Locomotion Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cross sectional, age-matched-controlled and monocentric study with an exploratory approach.

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 10, 2021
• Study Start: August 11, 2021
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: October 18, 2023

Record last verified: 2023-10

Locations

CH (1)