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Stop Tip-toeing Around Toe-walking

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ClinicalTrials.gov Identifier: NCT04879199
Recruitment Status : Not yet recruiting
First Posted : May 10, 2021
Last Update Posted : July 7, 2021
Sponsor:
Information provided by (Responsible Party):
University Children's Hospital Basel

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)


Condition or disease Intervention/treatment Phase
Spastic Cerebral Palsy (sCP) Diagnostic Test: Static stability measurement Diagnostic Test: Dynamic stability measurement Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cross sectional, age-matched-controlled and monocentric study with an exploratory approach.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Stop Tip-toeing Around Toe-walking: Towards a Better Understanding and More Effective Treatment of Toe-walkers With Cerebral Palsy
Estimated Study Start Date : August 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Typically Developing (TD) children
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
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.

Experimental: Spastic Cerebral Palsy (sCP) children
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
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.




Primary Outcome Measures :
  1. Static stability assessed by Center of Pressure (COP) shifts in anterior-posterior and mediolateral directions under each limb [ Time Frame: one time assessment at baseline (complete baseline assessments up to 3 hours) ]
    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)

  2. Static stability assessed by Visual Analogue Scale (VAS) [ Time Frame: one time assessment at baseline (complete baseline assessments up to 3 hours) ]
    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")

  3. Static stability assessed by Ratio between H-reflex and M-wave amplitude [ Time Frame: one time assessment at baseline (complete baseline assessments up to 3 hours) ]
    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)

  4. Dynamic stability assessed by COP shifts in combination with base of support trajectory [ Time Frame: one time assessment at baseline (complete baseline assessments up to 3 hours) ]
    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)

  5. Dynamic stability assessed by number of muscle synergies [ Time Frame: one time assessment at baseline (complete baseline assessments up to 3 hours) ]
    Number of muscle synergies assessed via the use of a sixteen-channel surface electromyography system

  6. Dynamic stability assessed by interlimb coordination [ Time Frame: one time assessment at baseline (complete baseline assessments up to 3 hours) ]
    Interlimb coordination will be calculated by using kinematic data from lower and upper extremities

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


Secondary Outcome Measures :
  1. Dynamic stability measurement assessed by kinematic data of upper & lower extremities (joint angles in degree) [ Time Frame: one time assessment at baseline (complete baseline assessments up to 3 hours) ]
    Dynamic stability measurement assessed by kinematic data of upper & lower extremities (joint angles in degree)

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

  3. Dynamic stability measurement assessed by spatiotemporal parameters: stride width [s] [ Time Frame: one time assessment at baseline (complete baseline assessments up to 3 hours) ]
    Dynamic stability measurement assessed by spatiotemporal parameters: stride width [s]

  4. Dynamic stability measurement assessed by spatiotemporal parameters: double support time [s] [ Time Frame: one time assessment at baseline (complete baseline assessments up to 3 hours) ]
    Dynamic stability measurement assessed by spatiotemporal parameters: double support time [s]

  5. Dynamic stability measurement assessed by spatiotemporal parameters: cadence [steps/min] [ Time Frame: one time assessment at baseline (complete baseline assessments up to 3 hours) ]
    Dynamic stability measurement assessed by spatiotemporal parameters: cadence [steps/min]

  6. Dynamic stability measurement assessed by spatiotemporal parameters: step length [m] [ Time Frame: one time assessment at baseline (complete baseline assessments up to 3 hours) ]
    Dynamic stability measurement assessed by spatiotemporal parameters: step length [m]



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04879199


Contacts
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Contact: Heide Elke Viehweger, Prof. Dr. med. +41 (0) 61 704 2829 Heide.Viehweger@ukbb.ch
Contact: Regine Lohss +41 (0) 61 704 2829 regine.lohss@ukbb.ch

Locations
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Switzerland
University Children's Hospital Basel, Neuroorthopedics I Human Locomotion Research
Basel, Switzerland, 4056
Contact: Heide Elke Viehweger, Prof. Dr. med.    +41 61 704 2829    Heide.Viehweger@ukbb.ch   
Contact: Regine Lohss Lohss    +41 61 704 2829    regine.lohss@ukbb.ch   
Principal Investigator: Heide Elke Viehweger, Prof. Dr. med.         
Sponsors and Collaborators
University Children's Hospital Basel
Investigators
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Principal Investigator: Heide Elke Viehweger, Prof. Dr. med. University Children's Hospital Basel, Neuroorthopedics I Human Locomotion Research
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Responsible Party: University Children's Hospital Basel
ClinicalTrials.gov Identifier: NCT04879199    
Other Study ID Numbers: 2021-00435; ks21Viehweger
First Posted: May 10, 2021    Key Record Dates
Last Update Posted: July 7, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Children's Hospital Basel:
tip-toeing
toe-walking
gait cycle
heel-strike
Static stability
Dynamic stability
Virtual Reality
Cerebral Palsy (CP)
Additional relevant MeSH terms:
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Cerebral Palsy
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases