Comparison of the Effectiveness of Walking Back Exercises... | NCT04694118

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

NCT04694118

Sponsor

Istanbul Medipol University Hospital

Status

Unknown status

Last Update Posted

Jan 6, 2021Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Cerebral Palsy, Spastic

Interventions

rebound therapy

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 4, 2021Actual

Primary Completion Date

Dec 15, 2021Estimated

Completion Date

Dec 15, 2021Estimated

First Submitted Date

Jan 1, 2021

First Submission Date that Met QC Criteria

Jan 1, 2021

First Posted Date

Jan 5, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 5, 2021

Last Update Posted Date

Jan 6, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

ulkuatasoy2017, Msc.physiotherapist, Istanbul Medipol University HospitalPrincipal Investigator

Lead Sponsor

Istanbul Medipol University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
15 hemiparetic cerebral palsy,walking back group	Experimental	GMFM I or II degreed 6-15 age range hemiparetic cerebral palsy	Other: rebound therapy
15 hemiparetic cerebral palsy,rebound therapy group	Experimental	GMFM I or II degreed 6-15 age range hemiparetic cerebral palsy	Other: rebound therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
rebound therapy	Other	3 days a week in 12 weeks	15 hemiparetic cerebral palsy,rebound therapy group 15 hemiparetic cerebral palsy,walking back group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

15 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
devrim tarakcı, assoc.prof.	Contact	4448544	1890	dtarakci@medipol.edu.tr

Overall Officials

Name	Affiliation	Role
ulku atasoy, msc.pt	PhD student	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Umran medical center	Recruiting	Istanbul	Uskudar		Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

all IPD that underlie results in a publication

Types

Study Protocol

Time Frame

starting 6 months after publication).

Access Criteria

Users and editors with journal memberships published for pubmed users

URL

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

Condition Browse Module

MeSH Terms

ID	Term
D002547	Cerebral Palsy

Ancestor Terms

ID	Term
D001925	Brain Damage, Chronic
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided