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NDT on Fall Risk in Cerebral Palsied Children

Primary Purpose

Cerebral Palsy, Spastic, Falling

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Neurodevelopmental Therapy (NDT)
Conventional Physiotherapy
Sponsored by
Pamukkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy, Spastic

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pamukkale University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment Group

Control Group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

LEGSys, Temporospatial Gait Analysis Device
Determining the patient's risk of falling by performing a kinetic analysis of the gait
LEGSys, Temporospatial Gait Analysis Device
Determining the patient's risk of falling by performing a kinetic analysis of the gait
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.
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.

Secondary Outcome Measures

Full Information

First Posted
July 6, 2023
Last Updated
July 13, 2023
Sponsor
Pamukkale University
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1. Study Identification

Unique Protocol Identification Number
NCT05956444
Brief Title
NDT on Fall Risk in Cerebral Palsied Children
Official Title
Effect of Neurodevelopmental Treatment on Fall Risk and Balance in Children With Spastic Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
October 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Spastic, Falling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Treated with only the treatment programs determined on the basis of conventional physiotherapy.
Intervention Type
Other
Intervention Name(s)
Neurodevelopmental Therapy (NDT)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional Physiotherapy
Intervention Description
Classical physiotherapy applications for balance.
Primary Outcome Measure Information:
Title
LEGSys, Temporospatial Gait Analysis Device
Description
Determining the patient's risk of falling by performing a kinetic analysis of the gait
Time Frame
Beginning of the study
Title
LEGSys, Temporospatial Gait Analysis Device
Description
Determining the patient's risk of falling by performing a kinetic analysis of the gait
Time Frame
8 weeks
Title
Pediatric Balance Scale (PBS)
Description
Functional balance was assessed using PBS, which consists of fourteen tasks similar to activities of daily living. Higher scores indicate better balance.
Time Frame
Beginning of the study
Title
Pediatric Balance Scale (PBS)
Description
Functional balance was assessed using PBS, which consists of fourteen tasks similar to activities of daily living. Higher scores indicate better balance.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatih Tekin, Prof.
Organizational Affiliation
Faculty Member
Official's Role
Study Chair
Facility Information:
Facility Name
Pamukkale University
City
Denizli
Country
Turkey

12. IPD Sharing Statement

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NDT on Fall Risk in Cerebral Palsied Children

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