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Completed

NCT Number: NCT05405881

Validity and Reliability of the PROprioception Measurement Tool (PROMT)

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?

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Key information

Age range

5 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Swiss Children's Rehab

Affoltern am Albis, Canton of Zurich, 8910, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Proprioception measurement tool

Other

No intervention, as it is a psychometric properties study

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Other outcomes

  1. Dynamic position sense with visual control

    Time frame: Through study completion, an average of 1 year

    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.

  2. Tactile localization task

    Time frame: Through study completion, an average of 1 year

    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.

  3. Selective control assessment of the lower extremity (SCALE)

    Time frame: Through study completion, an average of 1 year

    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).

  4. Modified Timed Up and go Test (mTUG)

    Time frame: Through study completion, an average of 1 year

    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

  5. Gross Motor Function Measure D&E (GMFM):

    Time frame: Through study completion, an average of 1 year

    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.

  6. Quality Function Measure (QFM)

    Time frame: 1 time-point

    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

  7. Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT)

    Time frame: Through study completion, an average of 1 year

    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.

  8. Functional Mobility Scale (FMS)

    Time frame: Through study completion, an average of 1 year

    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.

  9. Gillette Functional Assessment Questionnaire - walking Scale (FAQ)

    Time frame: Through study completion, an average of 1 year

    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.

  10. Feasibility Questionnaire

    Time frame: Through study completion, an average of 1 year

    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.

Sponsors and collaborators

Lead sponsor

University Children's Hospital, Zurich

Other

Collaborators

  • Queen Margaret University

Registry information

Official study 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.

Acronym: PROMT

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 6, 2022
Registry last updated
Dec 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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