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Completed

NCT Number: NCT05956444

NDT on Fall Risk in Cerebral Palsied Children

Children with spastic cerebral palsy experience falls due to weakness in balance skills and abnormalities in gait parameters. It is necessary to improve the quality of life of these children by reducing the frequency of falling. Aim of this study was to investigate the effect of Neurodevelopmental Treatment on the risk of falling and balance and to contribute to the literature on this subject. Cases were randomized into study and control groups. At the beginning of the study, the balance skills of all the cases with spastic cerebral palsy were measured with the Pediatric Balance Scale, and the gait parameters and fall risks were measured with the LEGSys Temporospatial Gait Analysis Device. Then, an 8-week, case-specific, neurodevelopmental therapy program with intensive gait and balance training was applied to the study group in a 45-minute single session, 2 days a week. The control group received 8 weeks of conventional physiotherapy. At the end of the treatment process, the evaluations were repeated with the same methods.

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Key information

Conditions

Cerebral Palsy, Spastic Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Falling Nervous System Diseases

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pamukkale University

Denizli, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Cerebral Palsy diagnosis
  • Spastic type
  • Gross Motor Function Classification System Level I and II

Exclusion criteria

  • Tendon release surgery or Botox application in the last 6 months

Treatment and study plan

Neurodevelopmental Therapy (NDT)

Other

In the treatment program; vestibular and proprioceptive training on the balance board; dynamic balance training in sitting with eyes open and closed, kneeling upright and standing; balance exercises in front of the mirror; standing on one leg with eyes open and closed to increase proprioceptive input; vestibular and proprioceptive training on exercise balls of the appropriate size; balance training on the trampoline; footpad sensory stimulation with different materials; weight-bearing training in sitting, crawling, kneeling and standing positions; functional reaching and throwing-holding exercises in different positions; multitasking pieces of training; gait exercises in various ways and training for climbing and descending stairs appropriate to the child's situation (assisted, unaided, symmetrical, reciprocal) took place.

Conventional Physiotherapy

Other

Classical physiotherapy applications for balance.

Primary outcomes

  1. LEGSys, Temporospatial Gait Analysis Device

    Time frame: Beginning of the study

    Determining the patient's risk of falling by performing a kinetic analysis of the gait

  2. LEGSys, Temporospatial Gait Analysis Device

    Time frame: 8 weeks

    Determining the patient's risk of falling by performing a kinetic analysis of the gait

  3. Pediatric Balance Scale (PBS)

    Time frame: Beginning of the study

    Functional balance was assessed using PBS, which consists of fourteen tasks similar to activities of daily living. Higher scores indicate better balance.

  4. Pediatric Balance Scale (PBS)

    Time frame: 8 weeks

    Functional balance was assessed using PBS, which consists of fourteen tasks similar to activities of daily living. Higher scores indicate better balance.

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Official study title

Effect of Neurodevelopmental Treatment on Fall Risk and Balance in Children With Spastic Cerebral Palsy

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 21, 2023
Registry last updated
Jul 21, 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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