Spastic Cerebral Palsy (sCP)NCT04879199
Stop Tip-toeing Around Toe-walking
A study testing Static stability measurement and Dynamic stability measurement in people with Spastic Cerebral Palsy (sCP), run by University Children's Hospital Basel at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Spastic Cerebral Palsy (sCP)
- What is being tested?
- Static stability measurement and Dynamic stability measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSwitzerland
- Study dates
- 11 Aug 2021to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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°)
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Children's Hospital Basel, Neuroorthopedics I Human Locomotion Research
Basel, 4056
About this study
Official title: Stop Tip-toeing Around Toe-walking: Towards a Better Understanding and More Effective Treatment of Toe-walkers With Cerebral Palsy
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.
Read more
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)
Read the 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.
- Conditions
- Spastic Cerebral Palsy (sCP)
- Being tested
- Static stability measurement, Dynamic stability measurement
- Keywords
- tip-toeing, toe-walking, gait cycle, heel-strike, Static stability, Dynamic stability, Virtual Reality, Cerebral Palsy (CP)
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Static stability measurementDiagnostic 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 measurementDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Static stability measurement; Diagnostic Test: Dynamic stability measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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")
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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")
Measured: 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)
Dynamic stability measurement assessed by kinematic data of upper \& lower extremities (joint angles in degree)
Measured: 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: walking speed (normalized to leg length) [m/(s*mm)]
Measured: 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: stride width [s]
Measured: one time assessment at baseline (complete baseline assessments up to 3 hours)
Dynamic stability measurement assessed by spatiotemporal parameters: double support time [s]
Dynamic stability measurement assessed by spatiotemporal parameters: double support time [s]
Measured: 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: cadence [steps/min]
Measured: 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: step length [m]
Measured: one time assessment at baseline (complete baseline assessments up to 3 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start11 Aug 2021
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spastic Cerebral Palsy (sCP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Cross sectional, age-matched-controlled and monocentric study with an exploratory approach.
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital Basel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heide Elke Viehweger, Prof. Dr. med., Principal investigator, University Children's Hospital Basel, Neuroorthopedics I Human Locomotion Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04879199
- Sponsor's protocol ID
- 2021-00435; ks21Viehweger
- Status last verified
- Oct 2023
- First submitted
- 3 May 2021
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stop Tip-toeing Around Toe-walking: Towards a Better Understanding and More Effective Treatment of Toe-walkers With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04879199
- Acronym / sponsor ID
- 2021-00435; ks21Viehweger
- Conditions
- Spastic Cerebral Palsy (sCP)
- Keywords
- tip-toeing, toe-walking, gait cycle, heel-strike, Static stability, Dynamic stability, Virtual Reality, Cerebral Palsy (CP)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University Children's Hospital BaselUniversity, hospital or other
- Study start
- 11 Aug 2021 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 10 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cross sectional, age-matched-controlled and monocentric study with an exploratory approach.
| Arm | Type | Receives |
|---|---|---|
| Typically Developing (TD) children | Experimental | Diagnostic Test: Static stability measurement, Diagnostic Test: Dynamic stability measurementStatic 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 | Experimental | Diagnostic Test: Static stability measurement, Diagnostic Test: Dynamic stability measurementStatic 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. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Static stability measurementThe 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 | Spastic Cerebral Palsy (sCP) children, Typically Developing (TD) children |
| Dynamic stability measurementThe 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. | Diagnostic test | Spastic Cerebral Palsy (sCP) children, Typically Developing (TD) children |
Primary outcome
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)
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")
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)
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)
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
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
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")
6 secondary outcomes
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 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: stride width [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]
Time frame: one time assessment at baseline (complete baseline assessments up to 3 hours)
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: step length [m]
Time frame: one time assessment at baseline (complete baseline assessments up to 3 hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heide Elke Viehweger, Prof. Dr. med. principal investigator
University Children's Hospital Basel, Neuroorthopedics I Human Locomotion Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Static stability measurement and Dynamic stability measurement in people with Spastic Cerebral Palsy (sCP), run by University Children's Hospital Basel at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.