Validity and Reliability of the PROprioception Measurement Tool (PROMT)

Not Applicable

Completed

• Conditions: Upper Motor Neurone Lesion; Child Development; Proprioceptive Disorders; Cerebral Palsy

• Registration Number: NCT05405881
• Lead Sponsor: University Children's Hospital, Zurich

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.

Study Timeline

• Study First Submitted: 2022-05-12
• Study First Submitted QC: 2022-06-01
• Study First Posted: 2022-06-06
• Study Start: 2022-10-01
• Primary Completion: 2023-08-30
• Study Completion: 2023-08-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-30
• Last Update Posted: 2023-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Active position sense	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.
Joint Movement Sense	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	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.

Trial Locations

Locations (1)

Swiss Children's Rehab; 🇨🇭 Affoltern am Albis, Zurich, Switzerland