Biomechanical Properties and Their Association With Balance and Functional Mobility in Children With Cerebral Palsy

NCT05818839 | Completed

• 1 other identifier: BEU-CP-01
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to investigate the differences in the biomechanical properties of the dorsal trunk and lower extremity muscles of children with unilateral spastic cerebral palsy compared with their typically developing peers, and the effect of these biomechanical properties on balance and functional mobility performance.

Conditions

Cerebral Palsy

Keywords

postural balance; muscle properties; mobility; paralysis; children

Outcome Measures

Primary Outcomes (6)

• The Pediatric Balance Scale

  The Pediatric Balance Scale assesses functional balance in three categories: self-care, mobility and social function, using 14 items. Each item is scored from 0 (indicating low function) to 4 (indicating highest function), with a maximum score of 56 points. A higher score indicates better balance.

  Baseline

• Trunk Control Measurement Scale

  The TCSM was used to assess seated trunk balance and consisted of 15 items. Each item was scored from 0 to 3, with 0 indicating inability to perform the task and 3 indicating the full performance of the item. A high score indicated good trunk control

  Baseline

• 2-Minute Walk Test

  The children were asked to walk at a normal pace, without running, and the distance they walked for 2 minutes was recorded.

  Baseline

• Timed Up and Go Test

  The children were seated with their feet in full contact with the floor, in a chair with back support only, and with their hip and knee joints at 90 degrees. On the start command, they were asked to walk 3 metres to the wall at a pace they felt comfortable with and then sit back down in the chair.

  Baseline

• Muscle tone (Hz)

  The muscle tone which is a biomechanical property of the muscles evaluated with a portable hand-held myotonometer. This myotonometer (MyotonPRO - Tallinn, Estonia) is non-invasive and provides a quantitative assessment of a muscle's biomechanical properties. The MyotonPRO applies a short-intensity mechanical impulse on the skin overlying the muscle or facia. The tissue's response then generates a signal that is recorded, and an internal software program produces an acceleration graph.

  Baseline

• Stiffness (N/m)

  The stiffness which is a biomechanical property of muscles will be evaluated with a portable hand-held myotonometer. This myotonometer (MyotonPRO - Tallinn, Estonia) is non-invasive and provides a quantitative assessment of a muscle's biomechanical properties. The MyotonPRO applies a short-intensity mechanical impulse on the skin overlying the muscle or facia. The tissue's response then generates a signal that is recorded, and an internal software program produces an acceleration graph.

  Baseline

Study Arms (2)

UCP

Children diagnosed with unilateral spastic cerebral palsy

TyD

Typically developing children

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children diagnosed with unilateral spastic cerebral palsy (GMFCS level I-II, spasticity level MAS ≤ 2) and their age-matched typically developing peers.

You may qualify if:

• aged between 4 and 12 years,
• spasticity level MAS≤2,
• mental level sufficient to understand commands given,
• and ambulation without the use of an orthosis or other device. In addition, children had to be GMFCS level I or II.

You may not qualify if:

• a history of spinal surgery or spinal orthosis use,
• uncorrected vision or hearing problems,
• severe epileptic seizures,
• lower extremity contractures,
• botulinum toxin A injection in the previous six months,
• lower extremity surgery in less than one year,
• use of pharmacological agents that affect muscle tone,
• and poor cooperation.
• aged between 4 and 12 years,
• no neurological or orthopaedic diagnosis,
• no known systemic problems,
• normal vision and hearing,
• and a mental level sufficient to understand the commands given.

Sponsors & Collaborators

• Ilke KARA: lead

Study Sites (1)

Istanbul Okan University

Istanbul, 34959, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy; Paralysis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Co-Investigator

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: April 19, 2023
• Study Start: July 1, 2022
• Primary Completion: November 20, 2022
• Study Completion: February 20, 2023
• Last Updated: April 19, 2023

Record last verified: 2023-04

Locations

TU (1)