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Treadmill With Ankle Weights on Balance in Spastic Cerebral Palsied Children

Primary Purpose

Cerebral Palsy

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Physical therapy program with treadmill training without using of ankle weights.
Physical therapy program with treadmill training with using of ankle weights.
Sponsored by
Beni-Suef University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Treadmill, Biodex Balance System, Cerebral Palsy

Eligibility Criteria

6 Years - 9 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

1-Children ages will be ranged from 6 to 9 years old. 2-Confirmed diagnosis of hemiparetic cerebral palsy by a pediatric neurologist.

3-Spasticity grades ranged from 1 to +1 according to modified Ashworth. 4-Balance problems (frequent falling especially when increasing speed or walking on uneven surface) based on the Biodex stability system.

5-Independent standing and walking. 6-Ability to follow simple verbal commands and instructions

Exclusion Criteria:

  1. Auditory or visual defects or any perceptual defects.
  2. Fixed deformities on both upper or/ lower limbs.
  3. Botox injection.
  4. Cardiovasucular disease.
  5. Surgery within the previous 24 months.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Physical therapy program with treadmill training without using of ankle weights.

    Physical therapy program with treadmill training with using of ankle weights.

    Arm Description

    Cerebral palsied children will receive the physical therapy program from 45- 60 min./ session in addition to gait training on treadmill for 30 min./ session.

    Cerebral palsied children will receive the physical therapy program from 45- 60 min./ session in addition to gait training on treadmill with ankle weights for 30 min./ session.

    Outcomes

    Primary Outcome Measures

    Balance
    Biodex Stability System will be used to measure overall stability index, anteroposterior stability index and mediolateral stability index.
    Muscle strength
    Handheld dynamometer (Lafayette) will be used to record dorsiflexors force in pounds (Lbs)

    Secondary Outcome Measures

    Functional balance assessment
    Pediatric Balance Scale will be used to assess functional balance. It contains 14 items (Sitting to standing-Standing to sitting-Transfers-Standing unsupported-Sitting unsupported-Standing with eyes closed-Standing with feet together-Standing with one foot in front-Standing on one foot-Turning 360 degrees-Turning to look behind-Retrieving object from floor-Placing alternate foot on stool-Reaching forward with outstretched arm) that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points.

    Full Information

    First Posted
    October 25, 2021
    Last Updated
    October 25, 2021
    Sponsor
    Beni-Suef University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05106829
    Brief Title
    Treadmill With Ankle Weights on Balance in Spastic Cerebral Palsied Children
    Official Title
    Effect of Treadmill Training Combined With Ankle Weights on Balance in Spastic Cerebral Palsied Children.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 1, 2021 (Anticipated)
    Primary Completion Date
    January 1, 2022 (Anticipated)
    Study Completion Date
    January 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Beni-Suef University

    4. Oversight

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

    5. Study Description

    Brief Summary
    The purpose of the study is to investigate the effect of treadmill training combined with ankle weights on balance in spastic cerebral palsied children.
    Detailed Description
    Cerebral palsy defined as a non-progressive, non-hereditary lesion of the cerebral cortex resulting in postural and motion disturbances. Spastic cerebral palsied children have deficits in the selection of appropriate sensory inputs for postural control. Balance is a complex motor skill often referred to as postural control which is the ability to maintain equilibrium in a gravitational field by keeping or returning the center of body mass over the base of support. Treadmill gait training supporting the body weight which simulates walking on flat land is prescribed in rehabilitation of spastic cerebral palsy to improve their balance or to reduce their gait disturbance. Several studies support the use of ankle weights during treadmill gait training to reinforce muscle strength and, improve the symmetry of gait while, there is no research conducted on balance in spastic cerebral palsied children. Hence, there is need to study the effect of treadmill training combined with ankle weights on balance in spastic cerebral palsied children. Fourty children with spastic hemiparetic cerebral palsied children (based on power analysis) from both sexes (6-9 years) will be recruited from different private pediatric physical therapy clinics. They will be divided randomly into control group (20 children) and study group (20 children). Control group will be participated in designed physical therapy program in addition to gait training on treadmill with full weight bearing without using of ankle weights. Study group will be participated in the same designed physical therapy program received by the control group in addition to gait training on treadmill with ankle weights on the affected side ankle.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cerebral Palsy
    Keywords
    Treadmill, Biodex Balance System, Cerebral Palsy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Physical therapy and ankle weights.
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    By random generator
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Physical therapy program with treadmill training without using of ankle weights.
    Arm Type
    Active Comparator
    Arm Description
    Cerebral palsied children will receive the physical therapy program from 45- 60 min./ session in addition to gait training on treadmill for 30 min./ session.
    Arm Title
    Physical therapy program with treadmill training with using of ankle weights.
    Arm Type
    Experimental
    Arm Description
    Cerebral palsied children will receive the physical therapy program from 45- 60 min./ session in addition to gait training on treadmill with ankle weights for 30 min./ session.
    Intervention Type
    Other
    Intervention Name(s)
    Physical therapy program with treadmill training without using of ankle weights.
    Intervention Description
    The physical therapy program include manual standing on the mat, manual standing on the mat with step forward and step backward, kneeling and half kneeling on the mat, changing position exercises from prone to standing and from supine to standing, equilibrium, protective and righting reactions using balance board and medical ball, balance training exercise from standing on the mat, strengthening exercises for weak dorsiflexors, stooping and recovery exercising from standing position, squatting to standing exercise, gait training in different directions and, stretching exercises for tight muscles (e.g: hip flexors, hamstrings and calf muscles in lower limb and for wrist flexors, pronators and elbow flexors in upper limb) + gait training on treadmill without ankle weights.
    Intervention Type
    Other
    Intervention Name(s)
    Physical therapy program with treadmill training with using of ankle weights.
    Intervention Description
    he physical therapy program include manual standing on the mat, manual standing on the mat with step forward and step backward, kneeling and half kneeling on the mat, changing position exercises from prone to standing and from supine to standing, equilibrium, protective and righting reactions using balance board and medical ball, balance training exercise from standing on the mat, strengthening exercises for weak dorsiflexors, stooping and recovery exercising from standing position, squatting to standing exercise, gait training in different directions and, stretching exercises for tight muscles (e.g: hip flexors, hamstrings and calf muscles in lower limb and for wrist flexors, pronators and elbow flexors in upper limb) + gait training on treadmill with ankle weights.
    Primary Outcome Measure Information:
    Title
    Balance
    Description
    Biodex Stability System will be used to measure overall stability index, anteroposterior stability index and mediolateral stability index.
    Time Frame
    Up to 8 weeks
    Title
    Muscle strength
    Description
    Handheld dynamometer (Lafayette) will be used to record dorsiflexors force in pounds (Lbs)
    Time Frame
    Up to 8 weeks
    Secondary Outcome Measure Information:
    Title
    Functional balance assessment
    Description
    Pediatric Balance Scale will be used to assess functional balance. It contains 14 items (Sitting to standing-Standing to sitting-Transfers-Standing unsupported-Sitting unsupported-Standing with eyes closed-Standing with feet together-Standing with one foot in front-Standing on one foot-Turning 360 degrees-Turning to look behind-Retrieving object from floor-Placing alternate foot on stool-Reaching forward with outstretched arm) that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points.
    Time Frame
    Up to 8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    9 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 1-Children ages will be ranged from 6 to 9 years old. 2-Confirmed diagnosis of hemiparetic cerebral palsy by a pediatric neurologist. 3-Spasticity grades ranged from 1 to +1 according to modified Ashworth. 4-Balance problems (frequent falling especially when increasing speed or walking on uneven surface) based on the Biodex stability system. 5-Independent standing and walking. 6-Ability to follow simple verbal commands and instructions Exclusion Criteria: Auditory or visual defects or any perceptual defects. Fixed deformities on both upper or/ lower limbs. Botox injection. Cardiovasucular disease. Surgery within the previous 24 months.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Eman Wagdy, PH.D
    Phone
    01008079576
    Email
    Eman.wagdy@pt.bsu.edu.eg

    12. IPD Sharing Statement

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    Treadmill With Ankle Weights on Balance in Spastic Cerebral Palsied Children

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