Validity and Reliability of the PROprioception Measurement Tool (PROMT)

NCT05405881 | Completed DMC

• 1 other identifier: BASEC Nr. 2021-01373
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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?

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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.

  Through study completion, an average of 1 year

• 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.

  Through study completion, an average of 1 year

• 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.

  Through study completion, an average of 1 year

Other Outcomes (10)

• Dynamic position sense with visual control

  Through study completion, an average of 1 year

• Tactile localization task

  Through study completion, an average of 1 year

• Selective control assessment of the lower extremity (SCALE)

  Through study completion, an average of 1 year

Study Arms (2)

Children with upper motor neuron lesions

OTHER

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)

Other: Proprioception measurement tool

Children without UMN lesions (developing typically)

OTHER

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)

Other: Proprioception measurement tool

Interventions

Proprioception measurement tool OTHER

No intervention, as it is a psychometric properties study

Children with upper motor neuron lesions; Children without UMN lesions (developing typically)

Eligibility Criteria

• Age: 5 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Children's Hospital, Zurich: lead
• Queen Margaret University: collaborator

Study Sites (1)

Swiss Children's Rehab

Affoltern am Albis, Canton of Zurich, 8910, Switzerland

Location

Related Publications (8)

• 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.

  PMID: 34872425 BACKGROUND

• 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.

  PMID: 29435801 BACKGROUND

• 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.

  PMID: 23767869 BACKGROUND

• 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.

  PMID: 17705910 BACKGROUND

• 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.

  PMID: 11002433 BACKGROUND

• 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.

  PMID: 33508563 BACKGROUND

• 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.

  PMID: 33896853 BACKGROUND

• 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.

  PMID: 19254610 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy; Somatosensory Disorders

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hubertus JA van Hedel

  University children's Hospital Zurich, Swiss children's Rehab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A cross-sectional observational psychometric study with repeated assessments.

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: June 6, 2022
• Study Start: October 1, 2022
• Primary Completion: August 30, 2023
• Study Completion: August 30, 2023
• Last Updated: December 1, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)