NDT on Fall Risk in Cerebral Palsied Children

Cerebral Palsy, Spastic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05956444
• Other study ID #: FallRisk
• Status: Completed
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: October 1, 2022

Study information

• Verified date: July 2023
• Source: Pamukkale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: October 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Cerebral Palsy, Spastic
• Falling
• Muscle Spasticity

Intervention

Other:
• Neurodevelopmental Therapy (NDT)
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
Classical physiotherapy applications for balance.

Locations

Country	Name	City	State
Turkey	Pamukkale University	Denizli

Sponsors (1)

Lead Sponsor	Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LEGSys, Temporospatial Gait Analysis Device	Determining the patient's risk of falling by performing a kinetic analysis of the gait	Beginning of the study
Primary	LEGSys, Temporospatial Gait Analysis Device	Determining the patient's risk of falling by performing a kinetic analysis of the gait	8 weeks
Primary	Pediatric Balance Scale (PBS)	Functional balance was assessed using PBS, which consists of fourteen tasks similar to activities of daily living. Higher scores indicate better balance.	Beginning of the study
Primary	Pediatric Balance Scale (PBS)	Functional balance was assessed using PBS, which consists of fourteen tasks similar to activities of daily living. Higher scores indicate better balance.	8 weeks