NCT04694118

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 1, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

January 4, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 5, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2021

Completed
Last Updated

January 6, 2021

Status Verified

January 1, 2021

Enrollment Period

12 months

First QC Date

January 1, 2021

Last Update Submit

January 5, 2021

Conditions

Keywords

Cerebral palsy,neurodevelopmental therapy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

3 days a week in 12 weeks

Also known as: walking back exercise
15 hemiparetic cerebral palsy,rebound therapy group15 hemiparetic cerebral palsy,walking back group

Eligibility Criteria

Age6 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Umran medical center

Istanbul, Uskudar, Turkey (Türkiye)

RECRUITING

Ulku Atasoy

Istanbul, Ümraniye, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • ulku atasoy, msc.pt

    PhD student

    PRINCIPAL INVESTIGATOR

Central Study Contacts

devrim tarakcı, assoc.prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomise controlled clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Msc.physiotherapist

Study Record Dates

First Submitted

January 1, 2021

First Posted

January 5, 2021

Study Start

January 4, 2021

Primary Completion

December 15, 2021

Study Completion

December 15, 2021

Last Updated

January 6, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will share

all IPD that underlie results in a publication

Shared Documents
STUDY PROTOCOL
Time Frame
starting 6 months after publication).
Access Criteria
Users and editors with journal memberships published for pubmed users
More information

Locations