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Completed

NCT Number: NCT05818839

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Okan University

Istanbul, 34959, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. The Pediatric Balance Scale

    Time frame: Baseline

    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.

  2. Trunk Control Measurement Scale

    Time frame: Baseline

    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

  3. 2-Minute Walk Test

    Time frame: Baseline

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

  4. Timed Up and Go Test

    Time frame: Baseline

    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.

  5. Muscle tone (Hz)

    Time frame: Baseline

    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.

  6. Stiffness (N/m)

    Time frame: Baseline

    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.

Sponsors and collaborators

Lead sponsor

Ilke KARA

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Apr 19, 2023
Registry last updated
Apr 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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