Stop Tip-toeing Around Toe-walking
- Conditions
- Spastic Cerebral Palsy (sCP)
- Interventions
- Diagnostic Test: Static stability measurementDiagnostic Test: Dynamic stability measurement
- Registration Number
- NCT04879199
- Lead Sponsor
- 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)
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Spastic Cerebral Palsy (sCP) children Static stability measurement 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. Typically Developing (TD) children Static stability measurement 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. Typically Developing (TD) children Dynamic stability measurement 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. Spastic Cerebral Palsy (sCP) children Dynamic stability measurement 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.
- Primary Outcome Measures
Name Time Method Static stability assessed by Center of Pressure (COP) shifts in anterior-posterior and mediolateral directions under each limb 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)
Dynamic stability assessed by number of muscle synergies 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
Static stability assessed by Visual Analogue Scale (VAS) 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")
Static stability assessed by Ratio between H-reflex and M-wave amplitude 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)
Dynamic stability assessed by COP shifts in combination with base of support trajectory 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)
Dynamic stability assessed by interlimb coordination 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
Dynamic stability assessed by Self-perceived degree of safety during walking in the VR environment using a Visual Analogue Scale (VAS) 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
Name Time Method 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 kinematic data of upper \& lower extremities (joint angles in degree)
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: walking speed (normalized to leg length) \[m/(s\*mm)\]
Dynamic stability measurement assessed by spatiotemporal parameters: cadence [steps/min] one time assessment at baseline (complete baseline assessments up to 3 hours) Dynamic stability measurement assessed by spatiotemporal parameters: cadence \[steps/min\]
Dynamic stability measurement assessed by spatiotemporal parameters: step length [m] one time assessment at baseline (complete baseline assessments up to 3 hours) Dynamic stability measurement assessed by spatiotemporal parameters: step length \[m\]
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: stride width \[s\]
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: double support time \[s\]
Trial Locations
- Locations (1)
University Children's Hospital Basel, Neuroorthopedics I Human Locomotion Research
🇨🇭Basel, Switzerland