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Effect of Nordic Walking on Gait-asymmetry Patterns in Children With Hemiparesis

Primary Purpose

Cerebral Palsy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
designed physical therapy program
Nordic walking
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Cerebral palsy, gait, spatio-temporal gait parameters, unilateral cerebral palcy, Nordic walking

Eligibility Criteria

6 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Their age will range from 6-10 years, from both sexes. Level I, II and III of gross motor functional classification system (GMFCS) (Jooyeon et al., 2011) Grade 1 and 1+ spasticity according to the Modified Ashworth Scale (MAS). (Cloptonetal et al., 2005). Exclusion Criteria: Uncontrolled epilepsy. Mental retardation or autistic features. Significant visual or auditory problems according to medical reports (audio-vestibular and ophthalmic examination), Structural or fixed soft tissue deformities of the lower and/or upper extremities. Neurological or orthopedic surgery in the past 12 months in the lower and/or upper extremities. Botox injection in the lower and/or upper extremities in the past 6 months.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    control group

    Nordic walking group

    Arm Description

    15 Children in this group will receive a designed physical therapy program for 60 minutes per session, three times a week, for three consecutive months.

    Children in this group will receive the same designed physical therapy program for 60 minutes per session, three times a week, for three consecutive months. while the Nordic walking training for 20 minutes will replace the functional gait training.

    Outcomes

    Primary Outcome Measures

    Assessment of gait
    The gait parameters will be assessed by kinovea software. Kinovea, free 2D motion analysis software, was created in 2009 via the non-profit collaboration of several researchers, athletes, coaches and programmers from all over the world. It enables the analysis of distances, angles, coordinates and spatial-temporal parameters frame by frame from a video recording. These measurements can be made from different perspectives, since the software carries out calibrations in non-perpendicular planes to the camera-object line analyzed. spatio-temporal parameters will be measured

    Secondary Outcome Measures

    Full Information

    First Posted
    September 29, 2022
    Last Updated
    November 30, 2022
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05644652
    Brief Title
    Effect of Nordic Walking on Gait-asymmetry Patterns in Children With Hemiparesis
    Official Title
    Effect of Nordic Walking on Gait-asymmetry Patterns in Children With Hemiparesis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2023 (Anticipated)
    Primary Completion Date
    January 30, 2024 (Anticipated)
    Study Completion Date
    January 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Nordic walking is a physical activity consisting of walking with poles similar to ski poles. The poles are designed for the purpose of activating the upper body during walking. The poles are equipped with rubber or spike tips and the walking itself resembles.
    Detailed Description
    Compared to normal walking in Nordic walking there is a stronger involvement of the upper body. Furthermore, by using the poles, the muscles in the upper body can be activated, and the length of each step taken is supposedly increased, resulting in a faster gait .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cerebral Palsy
    Keywords
    Cerebral palsy, gait, spatio-temporal gait parameters, unilateral cerebral palcy, Nordic walking

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    control group
    Arm Type
    Experimental
    Arm Description
    15 Children in this group will receive a designed physical therapy program for 60 minutes per session, three times a week, for three consecutive months.
    Arm Title
    Nordic walking group
    Arm Type
    Experimental
    Arm Description
    Children in this group will receive the same designed physical therapy program for 60 minutes per session, three times a week, for three consecutive months. while the Nordic walking training for 20 minutes will replace the functional gait training.
    Intervention Type
    Other
    Intervention Name(s)
    designed physical therapy program
    Intervention Description
    it will be applied for for 60 min weekly for 3 successive months in the form of three sets of exercises (20 minutes each) as follows: Flexibility exercises to restore joint mobility of soft tissues. Static and dynamic balance exercises Functional strengthening exercises. Functional gait training.
    Intervention Type
    Other
    Intervention Name(s)
    Nordic walking
    Intervention Description
    it will be conducted according to the guidelines of the International Nordic Walking Federation
    Primary Outcome Measure Information:
    Title
    Assessment of gait
    Description
    The gait parameters will be assessed by kinovea software. Kinovea, free 2D motion analysis software, was created in 2009 via the non-profit collaboration of several researchers, athletes, coaches and programmers from all over the world. It enables the analysis of distances, angles, coordinates and spatial-temporal parameters frame by frame from a video recording. These measurements can be made from different perspectives, since the software carries out calibrations in non-perpendicular planes to the camera-object line analyzed. spatio-temporal parameters will be measured
    Time Frame
    after 3 successive months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    10 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Their age will range from 6-10 years, from both sexes. Level I, II and III of gross motor functional classification system (GMFCS) (Jooyeon et al., 2011) Grade 1 and 1+ spasticity according to the Modified Ashworth Scale (MAS). (Cloptonetal et al., 2005). Exclusion Criteria: Uncontrolled epilepsy. Mental retardation or autistic features. Significant visual or auditory problems according to medical reports (audio-vestibular and ophthalmic examination), Structural or fixed soft tissue deformities of the lower and/or upper extremities. Neurological or orthopedic surgery in the past 12 months in the lower and/or upper extremities. Botox injection in the lower and/or upper extremities in the past 6 months.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Amira M Abd-elmonem, PhD
    Phone
    01155553316
    Email
    Dramira.salim2020@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Emam H El-negamy, Phd
    Organizational Affiliation
    Cairo university, faculty of physical therapy
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Maricha A Nashed, B.Sc.
    Organizational Affiliation
    Cairo university, faculty of physical therapy
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Effect of Nordic Walking on Gait-asymmetry Patterns in Children With Hemiparesis

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