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

Primary Purpose

Cerebral Palsy, Spastic

Status

Unknown status

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

rebound therapy

About this trial

This is an interventional treatment trial for Cerebral Palsy, Spastic focused on measuring Cerebral palsy,, neurodevelopmental therapy

Eligibility Criteria

6 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Umran medical centerRecruiting
Ulku AtasoyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

15 hemiparetic cerebral palsy,walking back group

15 hemiparetic cerebral palsy,rebound therapy group

Arm Description

GMFM I or II degreed 6-15 age range hemiparetic cerebral palsy

Outcomes

Primary Outcome Measures

changes in muscle volume

ultrasonic imaging

Secondary Outcome Measures

Full Information

NCT ID

NCT04694118

First Posted

January 1, 2021

Last Updated

January 5, 2021

Sponsor

Istanbul Medipol University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04694118

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Unknown status

Study Start Date

January 4, 2021 (Actual)

Primary Completion Date

December 15, 2021 (Anticipated)

Study Completion Date

December 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Istanbul Medipol University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cerebral Palsy, Spastic

Keywords

Cerebral palsy,, neurodevelopmental therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

randomise controlled clinical trial

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

15 hemiparetic cerebral palsy,walking back group

Arm Type

Experimental

Arm Description

GMFM I or II degreed 6-15 age range hemiparetic cerebral palsy

Arm Title

15 hemiparetic cerebral palsy,rebound therapy group

Arm Type

Experimental

Arm Description

GMFM I or II degreed 6-15 age range hemiparetic cerebral palsy

Intervention Type

Other

Intervention Name(s)

rebound therapy

Other Intervention Name(s)

walking back exercise

Intervention Description

3 days a week in 12 weeks

Primary Outcome Measure Information:

Title

changes in muscle volume

Description

ultrasonic imaging

Time Frame

one measurement at the beginning of the study, second measurement 8 weeks later, 3rd measurement at 12th week following

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

devrim tarakcı, assoc.prof.

Phone

4448544

Ext

1890

dtarakci@medipol.edu.tr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ulku atasoy, msc.pt

Organizational Affiliation

PhD student

Official's Role

Principal Investigator

Facility Information:

Facility Name

Umran medical center

City

İstanbul

State/Province

Uskudar

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

ülkü atasoy, msc.pt

Phone

+905435796261

ulkuatasoy2017@gmail.com

Facility Name

Ulku Atasoy

City

İstanbul

State/Province

Ümraniye

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

ulku atasoy, msc.pt

Phone

+905435796261

ulkuatasoy2017@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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 URL

https://pubmed.ncbi.nlm.nih.gov/

Learn more about this trial

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

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