NDT on Fall Risk in Cerebral Palsied Children

Not Applicable

Completed

• Conditions: Falling; Cerebral Palsy, Spastic
• Interventions: Other: Conventional Physiotherapy; Other: Neurodevelopmental Therapy (NDT)

• Registration Number: NCT05956444
• Lead Sponsor: Pamukkale University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-01
• Primary Completion: 2022-08-01
• Study Completion: 2022-10-01
• Status Verified: 2023-07
• Study First Submitted: 2023-07-06
• Study First Submitted QC: 2023-07-13
• Last Update Submitted: 2023-07-13
• Study First Posted: 2023-07-21
• Last Update Posted: 2023-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Conventional Physiotherapy	Treated with only the treatment programs determined on the basis of conventional physiotherapy.
Treatment Group	Conventional Physiotherapy	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.
Treatment Group	Neurodevelopmental Therapy (NDT)	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Pamukkale University; 🇹🇷 Denizli, Turkey