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

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34959
    • Istanbul Okan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion criteria for unilateral spastic cerebral palsy were:

• 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.

Exclusion criteria were:

• 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.

Inclusion criteria for controls were:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
UCP; Children diagnosed with unilateral spastic cerebral palsy
TyD; Typically developing children

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ilke KARA

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): November 20, 2022
• Study Completion (Actual): February 20, 2023

Study Registration Dates

• First Submitted: April 6, 2023
• First Submitted That Met QC Criteria: April 18, 2023
• First Posted (Actual): April 19, 2023

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 18, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: children; mobility; postural balance; paralysis; muscle properties
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: BEU-CP-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No