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Validity and Reliability of the PROprioception Measurement Tool (PROMT) (PROMT)

Primary Purpose

Child Development, Upper Motor Neurone Lesion, Cerebral Palsy

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Proprioception measurement tool
Sponsored by
University Children's Hospital, Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Child Development

Eligibility Criteria

5 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • Swiss Children's RehabRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Children with upper motor neuron lesions

Children without UMN lesions (developing typically)

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
May 12, 2022
Last Updated
May 15, 2023
Sponsor
University Children's Hospital, Zurich
Collaborators
Queen Margaret University
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1. Study Identification

Unique Protocol Identification Number
NCT05405881
Brief Title
Validity and Reliability of the PROprioception Measurement Tool (PROMT)
Acronym
PROMT
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
July 10, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Children's Hospital, Zurich
Collaborators
Queen Margaret University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Development, Upper Motor Neurone Lesion, Cerebral Palsy, Proprioceptive Disorders

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
A cross-sectional observational psychometric study with repeated assessments.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Children with upper motor neuron lesions
Arm Type
Other
Arm Description
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)
Arm Title
Children without UMN lesions (developing typically)
Arm Type
Other
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Proprioception measurement tool
Intervention Description
No intervention, as it is a psychometric properties study
Primary Outcome Measure Information:
Title
Joint Movement Sense
Description
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.
Time Frame
Through study completion, an average of 1 year
Title
Joint position sense
Description
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.
Time Frame
Through study completion, an average of 1 year
Title
Active position sense
Description
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.
Time Frame
Through study completion, an average of 1 year
Other Pre-specified Outcome Measures:
Title
Dynamic position sense with visual control
Description
The child has to confirm a particular position (criterion position) marked with a visual target, while the child moves the limb actively. Difference of degree (°) for each criterion position (delta), and the direction of the error (overestimation or underestimation of the position) are recorded.
Time Frame
Through study completion, an average of 1 year
Title
Tactile localization task
Description
A tactile input with a 10-gram monofilament on the sole of the foot must be identified by the child either on a map of the foot or directly by pointing to the sole of the foot. These are scored using a 4-point scale (0 of 3 = insufficient body representation, 1 of 3 = restricted body representation, 2 of 3 = diminished body representation; 3 of 3 = good body representation). Both legs are scored separately. Output: Total score per leg.
Time Frame
Through study completion, an average of 1 year
Title
Selective control assessment of the lower extremity (SCALE)
Description
To assess selective voluntary motor control of the lower extremity (hip, knee, upper ankle, lower ankle, and toes). Each joint is scored as 2 (normal), 1 (impaired), or 0 (unable). Both legs are scored separately. Output: Total Score (per leg).
Time Frame
Through study completion, an average of 1 year
Title
Modified Timed Up and go Test (mTUG)
Description
The child sits on a chair and is asked to stand up, walk 3 meters and touch a target, turn around, return to the chair, and sit down. The time for the task will be recorded
Time Frame
Through study completion, an average of 1 year
Title
Gross Motor Function Measure D&E (GMFM):
Description
The Dimension D assesses 13 tasks in a standing position, Dimension E contains 14 items of walking, running, or jumping tasks. For each Dimension, a percentage score will be evaluated.
Time Frame
Through study completion, an average of 1 year
Title
Quality Function Measure (QFM)
Description
To assesses the quality of gross motor function rated from a video recording of the child performing the GMFM. The QFM assesses five quality of movement attributes: alignment, co-ordination, dissociated movement, stability and weight-shift. For each GMFM-66 Stand/Walk item, the three most appropriate quality attributes have been pre-selected for scoring. Each quality attribute is scored on a 4-point response scale using item-specific response options described on the Quality FM score form
Time Frame
1 time-point
Title
Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT)
Description
Is a computer-adapted interview to assess daily activities, mobility, social/cognitive, and responsibility. PEDI CAT has been translated into German and shows good validity and reliability. The administration time of the short version is 10 minutes.
Time Frame
Through study completion, an average of 1 year
Title
Functional Mobility Scale (FMS)
Description
Is a score of the gait ability in the daily environment of the children over three distances (5meter, 50meter, and 500meter). For each distance, a score between 1-6 indicates the independence of walking (higher score the more independent the child is). The sum score will be calculated. The administration of this test takes 5 minutes. It will be conducted by interviewing the parents or caregivers.
Time Frame
Through study completion, an average of 1 year
Title
Gillette Functional Assessment Questionnaire - walking Scale (FAQ)
Description
The FAQ involves a range of walking abilities, describing various levels of mobility on a 10-level ordinal scale, with the levels differing in environment, terrains, or obstacles.
Time Frame
Through study completion, an average of 1 year
Title
Feasibility Questionnaire
Description
Includes following items: time tracking for the preparation of the test, for each PROMT modality, the export of the data, and for evaluation. The Number of technique issues. Subject feedback of the children with UMN is assessed with a visual analogue scale (measured in millimetres; (from 0-100; where 0 means very easy/or none, and 100 means very difficult/or extreme) on perception of pain or discomfort/comfort, demand for concentration and fatigue. Rater's subjective feedback assessed with a visual analogue scale (measured in millimetres; (from 0-100; where 0 means very easy/or none, and 100 means very difficult/or extreme) on application and performance of the PROMT modalities, estimation of the comprehensibility of the test instructions for the child.
Time Frame
Through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Petra Marsico, MSc
Phone
+44762 52 97
Email
petra.marsico@kispi.uzh.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Hubertus JA van Hedel, Prof
Phone
+41 44 762 52 91
Email
hubertus.vanhedel@kispi.uzh.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hubertus JA van Hedel
Organizational Affiliation
University children's Hospital Zurich, Swiss children's Rehab
Official's Role
Principal Investigator
Facility Information:
Facility Name
Swiss Children's Rehab
City
Affoltern am Albis
State/Province
Zurich
ZIP/Postal Code
8910
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Petra Marsico, MScPT
Phone
+41447625297
Email
petra.marsico@kispi.uzh.ch
First Name & Middle Initial & Last Name & Degree
Hubertus JA van Hedel, Prof
Phone
+41447625297
Email
Hubertus.vanhedel@kispi.uzh.ch

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34872425
Citation
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.
Results Reference
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PubMed Identifier
29435801
Citation
Prinsen 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.
Results Reference
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PubMed Identifier
23767869
Citation
Damiano 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.
Results Reference
background
PubMed Identifier
17705910
Citation
Dijkerman 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.
Results Reference
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PubMed Identifier
11002433
Citation
Palisano 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.
Results Reference
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PubMed Identifier
33508563
Citation
Uzun 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.
Results Reference
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PubMed Identifier
33896853
Citation
Zarkou 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.
Results Reference
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PubMed Identifier
19254610
Citation
Wingert 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.
Results Reference
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Validity and Reliability of the PROprioception Measurement Tool (PROMT)

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