NDT on Fall Risk in Cerebral Palsied Children

Sponsor
Pamukkale University (Other)
Overall Status
Completed
CT.gov ID
NCT05956444
Collaborator
(none)
44
1
2
4
11

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Neurodevelopmental Therapy (NDT)
  • Other: Conventional Physiotherapy
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Neurodevelopmental Treatment on Fall Risk and Balance in Children With Spastic Cerebral Palsy
Actual Study Start Date :
Jun 1, 2022
Actual Primary Completion Date :
Aug 1, 2022
Actual Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment Group

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)
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.

Other: Conventional Physiotherapy
Classical physiotherapy applications for balance.

Active Comparator: Control Group

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

Other: Conventional Physiotherapy
Classical physiotherapy applications for balance.

Outcome Measures

Primary Outcome Measures

  1. LEGSys, Temporospatial Gait Analysis Device [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 [8 weeks]

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

  3. Pediatric Balance Scale (PBS) [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) [8 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pamukkale University Denizli Turkey

Sponsors and Collaborators

  • Pamukkale University

Investigators

  • Study Chair: Fatih Tekin, Prof., Faculty Member

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fatih Tekin, Assist. Prof., Pamukkale University
ClinicalTrials.gov Identifier:
NCT05956444
Other Study ID Numbers:
  • FallRisk
First Posted:
Jul 21, 2023
Last Update Posted:
Jul 21, 2023
Last Verified:
Jul 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 21, 2023