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Completed

NCT Number: NCT04879199

Stop Tip-toeing Around Toe-walking

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)

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Key information

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Basel, 4056, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  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 outcomes

  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]

Sponsors and collaborators

Lead sponsor

University Children's Hospital Basel

Other

Registry information

Official study title

Stop Tip-toeing Around Toe-walking: Towards a Better Understanding and More Effective Treatment of Toe-walkers With Cerebral Palsy

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 10, 2021
Registry last updated
Oct 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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