Validity and Reliability of the PROprioception Measurement Tool (PROMT)

University of Zurich (UZH)

Status: Completed

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

Treatments: Other: Proprioception measurement tool

Study type: Interventional

Funder types: Other

Identifiers

NCT05405881

BASEC Nr. 2021-01373

Details and patient eligibility

About

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?

Full 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.

Enrollment: 99 patients

Sex: All

Ages: 5 to 19 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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99 participants in 2 patient groups

Children with upper motor neuron lesions

Other group

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)

Treatment:

Other: Proprioception measurement tool

Children without UMN lesions (developing typically)

Other group

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)

Treatment:

Other: Proprioception measurement tool