Clinical trial NCT05405881: Validity and Reliability of the PROprioception Measurement Tool (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
Overall status: COMPLETED
Phase: NA
Conditions: Child Development
Upper Motor Neurone Lesion
Cerebral Palsy
Proprioceptive Disorders
Lead sponsor: University Children's Hospital, Zurich
Sponsor class: OTHER
Collaborators: name: Queen Margaret University
First posted: 2022-06-06
Enrollment: 99
Sex: ALL
Minimum age (years): 5
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A cross-sectional observational psychometric study with repeated assessments.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Joint Movement Sense
timeFrame: Through study completion, an average of 1 year
measure: Joint position sense
timeFrame: Through study completion, an average of 1 year
measure: Active position sense
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
measure: Dynamic position sense with visual control
timeFrame: Through study completion, an average of 1 year
measure: Tactile localization task
timeFrame: Through study completion, an average of 1 year
measure: Selective control assessment of the lower extremity (SCALE)
timeFrame: Through study completion, an average of 1 year
measure: Modified Timed Up and go Test (mTUG)
timeFrame: Through study completion, an average of 1 year
measure: Gross Motor Function Measure D&E (GMFM):
timeFrame: Through study completion, an average of 1 year
measure: Quality Function Measure (QFM)
timeFrame: 1 time-point
measure: Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT)
timeFrame: Through study completion, an average of 1 year
measure: Functional Mobility Scale (FMS)
timeFrame: Through study completion, an average of 1 year
measure: Gillette Functional Assessment Questionnaire - walking Scale (FAQ)
timeFrame: Through study completion, an average of 1 year
measure: Feasibility Questionnaire
timeFrame: Through study completion, an average of 1 year
Locations:
city: Affoltern am Albis
country: Switzerland
facility: Swiss Children's Rehab
state: Zurich
Study officials:
affiliation: University children's Hospital Zurich, Swiss children's Rehab
name: Hubertus JA van Hedel
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.