Comparison of the Effectiveness of Walking Back Exercises and Rebound Therapy in Cerebral Palsy Rehabilitation

January 5, 2021 updated by: ulkuatasoy2017, Istanbul Medipol University Hospital

Purpose of the study:

To investigate the effect of walking back exercises and rebound therapy on muscle strength, functionality, balance and aerobic capacity in children with CP Implication for rehabilitation:Determining the effects of rehabilitative interventions (back and forth walking exercises and rebound therapy) to be applied in children with CP with objective measurement methods (muscle US, tetrax balance system) and evaluating the effects of the results on functionality and respiratory parameters

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Inclusion Criteria:

Being diagnosed with SP To be in the age range of 6-15 years, where effective communication can be provided in evaluation and treatment processes and when walking begins to mature Having adequate communication skills Being on level I or level II according to GMFM No impairment in visual functions in terms of not affecting postural control responses, Children with family consent

Study design:

Application of the evaluation methods specified at the beginning of the study to all 30 patients with CP who were randomly divided into 2 groups.

Re-evaluations were planned 8 weeks after the first evaluation of all cases who were continuing with structured neurodevelopmental treatment programs. In addition to the ongoing structured neurodevelopmental treatment programs; Group 1: 12 weeks / 3 days 20 minutes walking back exercises on normal ground, Group 2: Rebound therapy exercises, which are arranged according to the functional levels of the cases, will be applied in 12 weeks / 3 days for 20 minutes.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Uskudar
      • İstanbul, Uskudar, Turkey
        • Recruiting
        • Umran medical center
        • Contact:
    • Ümraniye
      • İstanbul, Ümraniye, Turkey

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 15 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Being diagnosed with hemiparetic SP To be in the age range of 6-15 years, where effective communication can be provided in evaluation and treatment processes and when walking begins to mature Having adequate communication skills Being on level I or level II according to KMFSS No impairment in visual functions in terms of not affecting postural control responses, Children with family consent

Exclusion Criteria:

  • Orthopedic surgery and / or botulinum toxin-A application for the lower extremity in the last 6 months Being at level III, level IV or level V according to KMFSS Severe convulsion situations that cannot be controlled with drugs Presence of a medical condition that prevents participation in the study Congenital malformation conditions accompanying CP

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 15 hemiparetic cerebral palsy,walking back group
GMFM I or II degreed 6-15 age range hemiparetic cerebral palsy
Other: rebound therapy
3 days a week in 12 weeks
Other Names:
  • walking back exercise
EXPERIMENTAL: 15 hemiparetic cerebral palsy,rebound therapy group
GMFM I or II degreed 6-15 age range hemiparetic cerebral palsy
Other: rebound therapy
3 days a week in 12 weeks
Other Names:
  • walking back exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in muscle volume
Time Frame: one measurement at the beginning of the study, second measurement 8 weeks later, 3rd measurement at 12th week following
ultrasonic imaging
one measurement at the beginning of the study, second measurement 8 weeks later, 3rd measurement at 12th week following

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Medipol University Hospital

Investigators

  • Principal Investigator: ulku atasoy, msc.pt, PhD student

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 4, 2021

Primary Completion (ANTICIPATED)

December 15, 2021

Study Completion (ANTICIPATED)

December 15, 2021

Study Registration Dates

First Submitted

January 1, 2021

First Submitted That Met QC Criteria

January 1, 2021

First Posted (ACTUAL)

January 5, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 6, 2021

Last Update Submitted That Met QC Criteria

January 5, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10840098-604.01.01-E.66352

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all IPD that underlie results in a publication

IPD Sharing Time Frame

starting 6 months after publication).

IPD Sharing Access Criteria

Users and editors with journal memberships published for pubmed users

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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