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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05818839
• Other study ID #: BEU-CP-01
• Status: Completed
• Start date: July 1, 2022
• Est. completion date: February 20, 2023

Study information

• Verified date: April 2023
• Source: Dokuz Eylul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 20, 2023
• Est. primary completion date: November 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy

Locations

Country	Name	City	State
Turkey	Istanbul Okan University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Ilke KARA

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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