Child DevelopmentPROMTNCT05405881
Validity and Reliability of the PROprioception Measurement Tool (PROMT)
A study testing Proprioception measurement tool in people with Child Development and Upper Motor Neurone Lesion, run by University Children's Hospital, Zurich at 1 site in Switzerland.
Trial summary
This project assesses the feasibility, reliability, and validity of the PROMT in children with a UMN lesion. The study questions are: is the newly developed PROMT a feasible, reliable, and valid tool to assess lower limb proprioception in children with UMN lesions? Does the PROMT differ between children with UMN… Read more about this study
- Who is it for?
- Ages 5 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Development, Upper Motor Neurone Lesion, Cerebral Palsy
- What is being tested?
- Proprioception measurement tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Oct 2022to 30 Aug 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 5 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- neuromotor impairments due to UMN lesions (diagnoses can be, for example, cerebral palsy (CP), acquired brain injuries, myelomeningocele, hydrocephalus)
- ability to sit with or without back support for 30 minutes
- ability to stand with or without support
- ability to do some steps
- informed consent.
Who cannot join
- severe visual impairment
- surgery within the last six months with involvement of the lower limbs
- botulinum toxin injection in the lower limbs within the previous three months
- unable to communicate pain or discomfort (verbally or nonverbally)
- noncompliance
- not able to follow simple short instructions
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Swiss Children's Rehab
Affoltern am Albis, Canton of Zurich, 8910
About this study
Official title: New Tool to Assess Proprioception of the Lower Limbs in Children With Upper Motor Neuron Lesions: Feasibility, Reliability, Validity, and Relevance for Motor Function.
This project assesses the feasibility, reliability, and validity of the PROMT in children with a UMN lesion. The study questions are: is the newly developed PROMT a feasible, reliable, and valid tool to assess lower limb proprioception in children with UMN lesions? Does the PROMT differ between children with UMN lesion and controlled neurotypically developing peers? Further, does the proprioception modalities assessed with the PROMT correlate with motor function in this group of children?
Read the detailed description
Somatosensory function is essential to all our movements and activities. This is also the case for children with Upper Motor Neuron (UMN) lesions, such as cerebral palsy or acquired brain lesions. Especially one category of somatosensory function, namely proprioception, seems to play a crucial role in motor control and motor learning. To date, no validated or reliable assessment tool exists to assess the different modalities of proprioception in children with UMN lesions. Therefore, the investigators designed an Inertial Measurement Unit's (IMU)-based outcome measure to assess three proprioception modalities. These are joint movement, joint position, and dynamic position sense. With the Unity software, the investigators have created a test setting that intuitively guides the tester and the participant through the standardised measurement procedures. The aim of this study is to investigate the feasibility, reliability, validity, and relevance in correspondence to motor function of this newly developed measurement tool.
The investigators plan to recruit 50 children with and 50 without UMN lesions. The feasibility criteria will be evaluated in the group of children with UMN lesions. The children with UMN lesions will be tested three times, twice from the same rater and once from another rater, to investigate inter-rater and test-retest reliability. To assess the relevance of this somatosensory category on motor function in children with UMN lesions, specific assessments on the body function, activity, and participation level of the international classification of functioning, disability, and health (ICF) will be performed. The aged-matched peers will be assessed once with the PROMT.
The PROMT should allow clinicians to assess lower limb proprioception in children with UMN lesions in a child-friendly manner. The analysis of the reliability results should allow to measure changes and probable association to motor function can lead us to further research questions to supplement the therapy program.
- Being tested
- Proprioception measurement tool
- Medical subject headings
- Cerebral Palsy, Somatosensory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioception measurement toolOther
No intervention, as it is a psychometric properties study
| Study group | Role | What they receive |
|---|---|---|
| Children with upper motor neuron lesions | Other | With the Proprioception Measurement Tool (PROMT) following modalities are assessed: joint movement sense, joint position sense, and active position sense. The child has to wear on each leg two Shimmer Sensors on the lower limb and the foot. The child sits on a table or bench, and the feet are free-hanging. A table is positioned in front of the child to place the smartphone or convertible notebook at a distance where the child can press the digital button. The table with an additional U-table platform prevents the child's view towards the legs. The duration of these three tests is 20 minutes. The comparator assessments on each level of the ICF-CY are conducted, and a feasibility questionnaire (detailed described under chapter outcome measures) Receives: Other: Proprioception measurement tool |
| Children without UMN lesions (developing typically) | Other | With the Proprioception Measurement Tool (PROMT) following modalities are assessed: joint movement sense, joint position sense, and active position sense. The child has to wear on each leg two Shimmer Sensors on the lower limb and the foot. The child sits on a table or bench, and the feet are free-hanging. A table is positioned in front of the child to place the smartphone or convertible notebook at a distance where the child can press the digital button. The table with an additional U-table platform prevents the child's view towards the legs. The duration of these three tests is 20 minutes. A feasibility questionnaire (detailed described under chapter outcome measures) Receives: Other: Proprioception measurement tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Joint Movement Sense
The child must recognise and confirm the direction of movement on the digital button, while the limb will be moved by the tester in a speed of 5-15°/second. Percentage of correct identified directions out of four trials and the angle in degree (°) until the movement detection for each trial are recorded.
Measured: Through study completion, an average of 1 year
Joint position sense
The child has to confirm a particular position (criterion position), while the limb is moved passively. Difference of degree (°) for each criterion position (delta), and the direction of the error (overestimation or underestimation of the position) are recorded.
Measured: Through study completion, an average of 1 year
Active position sense
The child has to confirm a particular position (criterion position), while the child moves the limb active. Difference of degree (°) for each criterion position (delta), and the direction of the error (overestimation or underestimation of the position) are recorded.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start1 Oct 2022
- Primary completion30 Aug 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Child DevelopmentStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- A cross-sectional observational psychometric study with repeated assessments.
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Margaret University
- Responsible party
- Sponsor
- Investigators
- Hubertus JA van Hedel, Principal investigator, University children's Hospital Zurich, Swiss children's Rehab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05405881
- Sponsor's protocol ID
- BASEC Nr. 2021-01373
- Acronym
- PROMT
- Status last verified
- Nov 2023
- First submitted
- 12 May 2022
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marsico P, Meier L, van der Linden ML, Mercer TH, van Hedel HJA. Psychometric Properties of Lower Limb Somatosensory Function and Body Awareness Outcome Measures in Children with Upper Motor Neuron Lesions: A Systematic Review. Dev Neurorehabil. 2022 Jul;25(5):314-327. doi: 10.1080/17518423.2021.2011976. Epub 2021 Dec 6.
PubMed 34872425Prinsen CAC, Mokkink LB, Bouter LM, Alonso J, Patrick DL, de Vet HCW, Terwee CB. COSMIN guideline for systematic reviews of patient-reported outcome measures. Qual Life Res. 2018 May;27(5):1147-1157. doi: 10.1007/s11136-018-1798-3. Epub 2018 Feb 12.
PubMed 29435801Damiano DL, Wingert JR, Stanley CJ, Curatalo L. Contribution of hip joint proprioception to static and dynamic balance in cerebral palsy: a case control study. J Neuroeng Rehabil. 2013 Jun 15;10(1):57. doi: 10.1186/1743-0003-10-57.
PubMed 23767869Dijkerman HC, de Haan EH. Somatosensory processes subserving perception and action. Behav Brain Sci. 2007 Apr;30(2):189-201; discussion 201-39. doi: 10.1017/S0140525X07001392.
PubMed 17705910Palisano RJ, Hanna SE, Rosenbaum PL, Russell DJ, Walter SD, Wood EP, Raina PS, Galuppi BE. Validation of a model of gross motor function for children with cerebral palsy. Phys Ther. 2000 Oct;80(10):974-85.
PubMed 11002433Uzun Akkaya K, Elbasan B. An investigation of the effect of the lower extremity sensation on gait in children with cerebral palsy. Gait Posture. 2021 Mar;85:25-30. doi: 10.1016/j.gaitpost.2020.12.026. Epub 2020 Dec 28.
PubMed 33508563Zarkou A, Lee SCK, Prosser L, Hwang S, Franklin C, Jeka J. Foot and ankle somatosensory deficits in children with cerebral palsy: A pilot study. J Pediatr Rehabil Med. 2021;14(2):247-255. doi: 10.3233/PRM-190643.
PubMed 33896853Wingert JR, Burton H, Sinclair RJ, Brunstrom JE, Damiano DL. Joint-position sense and kinesthesia in cerebral palsy. Arch Phys Med Rehabil. 2009 Mar;90(3):447-53. doi: 10.1016/j.apmr.2008.08.217.
PubMed 19254610
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Tool to Assess Proprioception of the Lower Limbs in Children With Upper Motor Neuron Lesions: Feasibility, Reliability, Validity, and Relevance for Motor Function.
- ClinicalTrials.gov ID
- NCT05405881
- Acronym / sponsor ID
- PROMT / BASEC Nr. 2021-01373
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Collaborators
- Queen Margaret University
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 6 Jun 2022 (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.
This project assesses the feasibility, reliability, and validity of the PROMT in children with a UMN lesion. The study questions are: is the newly developed PROMT a feasible, reliable, and valid tool to assess lower limb proprioception in children with UMN lesions? Does the PROMT differ between children with UMN lesion and controlled neurotypically developing peers? Further, does the proprioception modalities assessed with the PROMT correlate with motor function in this group of children?
Detailed description
Somatosensory function is essential to all our movements and activities. This is also the case for children with Upper Motor Neuron (UMN) lesions, such as cerebral palsy or acquired brain lesions. Especially one category of somatosensory function, namely proprioception, seems to play a crucial role in motor control and motor learning. To date, no validated or reliable assessment tool exists to assess the different modalities of proprioception in children with UMN lesions. Therefore, the investigators designed an Inertial Measurement Unit's (IMU)-based outcome measure to assess three proprioception modalities. These are joint movement, joint position, and dynamic position sense. With the Unity software, the investigators have created a test setting that intuitively guides the tester and the participant through the standardised measurement procedures. The aim of this study is to investigate the feasibility, reliability, validity, and relevance in correspondence to motor function of this newly developed measurement tool.
The investigators plan to recruit 50 children with and 50 without UMN lesions. The feasibility criteria will be evaluated in the group of children with UMN lesions. The children with UMN lesions will be tested three times, twice from the same rater and once from another rater, to investigate inter-rater and test-retest reliability. To assess the relevance of this somatosensory category on motor function in children with UMN lesions, specific assessments on the body function, activity, and participation level of the international classification of functioning, disability, and health (ICF) will be performed. The aged-matched peers will be assessed once with the PROMT.
The PROMT should allow clinicians to assess lower limb proprioception in children with UMN lesions in a child-friendly manner. The analysis of the reliability results should allow to measure changes and probable association to motor function can lead us to further research questions to supplement the therapy program.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A cross-sectional observational psychometric study with repeated assessments.
| Arm | Type | Receives |
|---|---|---|
| Children with upper motor neuron lesions | Other | Other: Proprioception measurement toolWith the Proprioception Measurement Tool (PROMT) following modalities are assessed: joint movement sense, joint position sense, and active position sense. The child has to wear on each leg two Shimmer Sensors on the lower limb and the foot. The child sits on a table or bench, and the feet are free-hanging. A table is positioned in front of the child to place the smartphone or convertible notebook at a distance where the child can press the digital button. The table with an additional U-table platform prevents the child's view towards the legs. The duration of these three tests is 20 minutes. The comparator assessments on each level of the ICF-CY are conducted, and a feasibility questionnaire (detailed described under chapter outcome measures) |
| Children without UMN lesions (developing typically) | Other | Other: Proprioception measurement toolWith the Proprioception Measurement Tool (PROMT) following modalities are assessed: joint movement sense, joint position sense, and active position sense. The child has to wear on each leg two Shimmer Sensors on the lower limb and the foot. The child sits on a table or bench, and the feet are free-hanging. A table is positioned in front of the child to place the smartphone or convertible notebook at a distance where the child can press the digital button. The table with an additional U-table platform prevents the child's view towards the legs. The duration of these three tests is 20 minutes. A feasibility questionnaire (detailed described under chapter outcome measures) |
Who may qualify
- Ages
- 5 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- neuromotor impairments due to UMN lesions (diagnoses can be, for example, cerebral palsy (CP), acquired brain injuries, myelomeningocele, hydrocephalus)
- ability to sit with or without back support for 30 minutes
- ability to stand with or without support
- ability to do some steps
- informed consent.
Key exclusion criteria (6 listed)
- severe visual impairment
- surgery within the last six months with involvement of the lower limbs
- botulinum toxin injection in the lower limbs within the previous three months
- unable to communicate pain or discomfort (verbally or nonverbally)
- noncompliance
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 |
|---|---|---|
| Proprioception measurement toolNo intervention, as it is a psychometric properties study | Other | Children with upper motor neuron lesions, Children without UMN lesions (developing typically) |
Primary outcome
Joint Movement Sense
Time frame: Through study completion, an average of 1 year
The child must recognise and confirm the direction of movement on the digital button, while the limb will be moved by the tester in a speed of 5-15°/second. Percentage of correct identified directions out of four trials and the angle in degree (°) until the movement detection for each trial are recorded.
Joint position sense
Time frame: Through study completion, an average of 1 year
The child has to confirm a particular position (criterion position), while the limb is moved passively. Difference of degree (°) for each criterion position (delta), and the direction of the error (overestimation or underestimation of the position) are recorded.
Active position sense
Time frame: Through study completion, an average of 1 year
The child has to confirm a particular position (criterion position), while the child moves the limb active. Difference of degree (°) for each criterion position (delta), and the direction of the error (overestimation or underestimation of the position) are recorded.
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 1 Dec 2023.
- Background: PubMed 34872425Marsico P, Meier L, van der Linden ML, Mercer TH, van Hedel HJA. Psychometric Properties of Lower Limb Somatosensory Function and Body Awareness Outcome Measures in Children with Upper Motor Neuron Lesions: A Systematic Review. Dev Neurorehabil. 2022 Jul;25(5):314-327. doi: 10.1080/17518423.2021.2011976. Epub 2021 Dec 6.
- Background: PubMed 29435801Prinsen CAC, Mokkink LB, Bouter LM, Alonso J, Patrick DL, de Vet HCW, Terwee CB. COSMIN guideline for systematic reviews of patient-reported outcome measures. Qual Life Res. 2018 May;27(5):1147-1157. doi: 10.1007/s11136-018-1798-3. Epub 2018 Feb 12.
- Background: PubMed 23767869Damiano DL, Wingert JR, Stanley CJ, Curatalo L. Contribution of hip joint proprioception to static and dynamic balance in cerebral palsy: a case control study. J Neuroeng Rehabil. 2013 Jun 15;10(1):57. doi: 10.1186/1743-0003-10-57.
- Background: PubMed 17705910Dijkerman HC, de Haan EH. Somatosensory processes subserving perception and action. Behav Brain Sci. 2007 Apr;30(2):189-201; discussion 201-39. doi: 10.1017/S0140525X07001392.
- Background: PubMed 11002433Palisano RJ, Hanna SE, Rosenbaum PL, Russell DJ, Walter SD, Wood EP, Raina PS, Galuppi BE. Validation of a model of gross motor function for children with cerebral palsy. Phys Ther. 2000 Oct;80(10):974-85.
- Background: PubMed 33508563Uzun Akkaya K, Elbasan B. An investigation of the effect of the lower extremity sensation on gait in children with cerebral palsy. Gait Posture. 2021 Mar;85:25-30. doi: 10.1016/j.gaitpost.2020.12.026. Epub 2020 Dec 28.
- Background: PubMed 33896853Zarkou A, Lee SCK, Prosser L, Hwang S, Franklin C, Jeka J. Foot and ankle somatosensory deficits in children with cerebral palsy: A pilot study. J Pediatr Rehabil Med. 2021;14(2):247-255. doi: 10.3233/PRM-190643.
- Background: PubMed 19254610Wingert JR, Burton H, Sinclair RJ, Brunstrom JE, Damiano DL. Joint-position sense and kinesthesia in cerebral palsy. Arch Phys Med Rehabil. 2009 Mar;90(3):447-53. doi: 10.1016/j.apmr.2008.08.217.
- Individual participant dataSharing planned: No
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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.
Hubertus JA van Hedel principal investigator
University children's Hospital Zurich, Swiss children's Rehab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proprioception measurement tool in people with Child Development and Upper Motor Neurone Lesion, run by University Children's Hospital, Zurich 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 5 inclusion and 6 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 1 Dec 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?
Joint Movement Sense (time frame: Through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05405881, which also lists 8 linked publications.
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 1 Dec 2023.