NDT on Fall Risk in Cerebral Palsied Children

NCT05956444 | Completed

• 1 other identifier: FallRisk
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebral Palsy, Spastic; Falling

Outcome Measures

Primary Outcomes (4)

• LEGSys, Temporospatial Gait Analysis Device

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

  Beginning of the study

• LEGSys, Temporospatial Gait Analysis Device

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

  8 weeks

• 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

• 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

Study Arms (2)

Treatment Group

EXPERIMENTAL

Treated with both the treatment programs determined on the basis of the NDT and conventional physiotherapy. Programs prepared specifically for each child, in a 45-minute single session, 2 days a week, for 8 weeks in total. Each child was given a treatment program tailored to their needs.

Other: Neurodevelopmental Therapy (NDT); Other: Conventional Physiotherapy

Control Group

ACTIVE COMPARATOR

Treated with only the treatment programs determined on the basis of conventional physiotherapy.

Other: Conventional Physiotherapy

Interventions

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.

Treatment Group

Conventional Physiotherapy OTHER

Classical physiotherapy applications for balance.

Control Group; Treatment Group

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University

Denizli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Fatih Tekin, Prof.

  Faculty Member

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof.

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: July 21, 2023
• Study Start: June 1, 2022
• Primary Completion: August 1, 2022
• Study Completion: October 1, 2022
• Last Updated: July 21, 2023

Record last verified: 2023-07

Locations

TU (1)