Stop Tip-toeing Around Toe-walking

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

Static stability measurement

Dynamic stability measurement

About this trial

This is an interventional diagnostic trial for Spastic Cerebral Palsy (sCP) focused on measuring tip-toeing, toe-walking, gait cycle, heel-strike, Static stability, Dynamic stability, Virtual Reality, Cerebral Palsy (CP)

Eligibility Criteria

7 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Typically Developing (TD) children

Spastic Cerebral Palsy (sCP) children

Arm 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.

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.

Outcomes

Primary Outcome Measures

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)

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")

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)

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)

Dynamic stability assessed by number of muscle synergies

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

Dynamic stability assessed by interlimb coordination

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)

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

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)]

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

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

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

Dynamic stability measurement assessed by spatiotemporal parameters: step length [m]

Full Information

NCT ID

NCT04879199

First Posted

May 3, 2021

Last Updated

October 17, 2023

Sponsor

University Children's Hospital Basel

1. Study Identification

Unique Protocol Identification Number

NCT04879199

Brief Title

Stop Tip-toeing Around Toe-walking

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

August 11, 2021 (Actual)

Primary Completion Date

September 30, 2023 (Actual)

Study Completion Date

September 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Children's Hospital Basel

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spastic Cerebral Palsy (sCP)

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

46 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Typically Developing (TD) children

Arm Type

Experimental

Arm 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.

Arm Title

Spastic Cerebral Palsy (sCP) children

Arm Type

Experimental

Arm 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.

Intervention Type

Diagnostic Test

Intervention Name(s)

Static stability measurement

Intervention Description

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.

Intervention Type

Diagnostic Test

Intervention Name(s)

Dynamic stability measurement

Intervention Description

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 Measure Information:

Title

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

Description

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)

Time Frame

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

Title

Static stability assessed by Visual Analogue Scale (VAS)

Description

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")

Time Frame

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

Title

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

Description

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)

Time Frame

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

Title

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

Description

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)

Time Frame

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

Title

Dynamic stability assessed by number of muscle synergies

Description

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

Time Frame

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

Title

Dynamic stability assessed by interlimb coordination

Description

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

Time Frame

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

Title

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

Description

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")

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

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)

Title

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

Description

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)

Title

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

Description

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

Time Frame

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

Title

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

Description

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)

Title

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

Description

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

Time Frame

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

Title

Dynamic stability measurement assessed by spatiotemporal parameters: step length [m]

Description

Dynamic stability measurement assessed by spatiotemporal parameters: step length [m]

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

7 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Heide Elke Viehweger, Prof. Dr. med.

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Basel

ZIP/Postal Code

4056

Country

Switzerland

Spastic Cerebral Palsy (sCP)

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial