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

Sponsor
Istanbul Medipol University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04694118
Collaborator
(none)
30
Enrollment
2
Locations
2
Arms
11.3
Anticipated Duration (Months)
15
Patients Per Site
1.3
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Other: rebound therapy
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
randomise controlled clinical trialrandomise controlled clinical trial
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison of the Effectiveness of Walking Back Exercises and Rebound Therapy in Cerebral Palsy Rehabilitation
Actual Study Start Date :
Jan 4, 2021
Anticipated Primary Completion Date :
Dec 15, 2021
Anticipated Study Completion Date :
Dec 15, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. changes in muscle volume [one measurement at the beginning of the study, second measurement 8 weeks later, 3rd measurement at 12th week following]

      ultrasonic imaging

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 15 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Umran medical center İstanbul Uskudar Turkey
    2 Ulku Atasoy İstanbul Ümraniye Turkey

    Sponsors and Collaborators

    • Istanbul Medipol University Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ulkuatasoy2017, Msc.physiotherapist, Istanbul Medipol University Hospital
    ClinicalTrials.gov Identifier:
    NCT04694118
    Other Study ID Numbers:
    • 10840098-604.01.01-E.66352
    First Posted:
    Jan 5, 2021
    Last Update Posted:
    Jan 6, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by ulkuatasoy2017, Msc.physiotherapist, Istanbul Medipol University Hospital
    Cerebral palsy,
    neurodevelopmental therapy
    Additional relevant MeSH terms:
    Paralysis
    Cerebral Palsy

    Study Results

    No Results Posted as of Jan 6, 2021