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Effect of Task-oriented Circuit Training on Gait Kinematics, Pelvic Symmetry and Endurance in Children With Hemiplegia

Primary Purpose

Cerebral Palsy, Spastic

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Task-oriented circuit training
Selected Physical therapy program
Sponsored by
Horus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy, Spastic focused on measuring hemiplegic cerebral palsy

Eligibility Criteria

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

Inclusion Criteria:

  • Their age will be ranged from 7-10 years.
  • Their motor function will be at level I and II according to Gross Motor Function Classification System GMFCS (Palisano et al., 2008).
  • The degree of spasticity will range from mild to moderate according to Modified Ashworth Scale (Bohannon and Smith, 1987).
  • They will be able to follow instructions during evaluation and treatment.

Exclusion Criteria:

Children will be excluded from the study if they have:

  • Other types of cerebral palsy.
  • Cardiovascular or respiratory disorders.
  • Botulinium muscular injection in the last 6 months
  • Surgical interference in lower limbs and/or spine.
  • Muscloskeletal problems or fixed deformities in the spine and/or lower extremities.
  • seizures.
  • Visual or hearing impairment.

Sites / Locations

  • Outpatient clinic, Faculty of Physical Therapy, Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Selected Physical Therapy group

Task-oriented circuit training group

Arm Description

will receive a selected physical therapy program for 90 minutes, 3 times/week for 3 successive months.

Children allocated to the study group will receive the same selected physical therapy program given to the control group for 45 minutes in addition to 45 minutes task-oriented circuit training program. The frequency of the whole program will be three times per week, for three months.

Outcomes

Primary Outcome Measures

Assessing the change in Angular displacement of joints during gait cycle
assessment via using 2D gait analysis by Kinovea software in order to measure change in angular displacement of joints during gait cycle including: angle of ankle dorsiflexion at initial contact, angle of knee extension at midstance and angle of hip extension during terminal stance. All of these measurements have the same unit which is (angle in degrees)
Assessing the change in Pelvic symmetry
by using palpation meter inclinometer to measure the change in anterior and lateral pelvic tilting angles in degrees
Assessing the change in spatial parameters of gait
assessment via using 2D gait analysis by Kinovea software in order to measure change in step length and stride length in centimeters.
Assessing the change in Temporal parameters of gait
assessment via using 2D gait analysis by Kinovea software in order to measure change in cadence (number of steps/minute) and walking speed (meter/minute)

Secondary Outcome Measures

Assessing the change in Trunk muscles endurance
Endurance of the trunk muscles will be evaluated using four endurance tests designed to establish the change in isometric trunk muscles endurance including; prone plank test (sec), timed partial curl up test (sec), front abdominal power test (cm) and unilateral supine bridge test (sec). For each trunk endurance measure, the examiner will instruct the child to hold the test position as long as possible prior to all testing. Each position will be tested three times and the average time will be recorded.

Full Information

First Posted
February 9, 2021
Last Updated
March 18, 2022
Sponsor
Horus University
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1. Study Identification

Unique Protocol Identification Number
NCT04761263
Brief Title
Effect of Task-oriented Circuit Training on Gait Kinematics, Pelvic Symmetry and Endurance in Children With Hemiplegia
Official Title
Effect of Task-oriented Circuit Training on Gait Kinematics, Pelvic Symmetry and Endurance in Children With Hemiplegia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
February 7, 2021 (Actual)
Primary Completion Date
February 15, 2022 (Actual)
Study Completion Date
March 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Horus 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
Statement of the problem: Does task-oriented circuit training have an effect on kinematic parameters of gait, pelvic symmetry and trunk endurance in children with hemiplegic CP? Purpose of the study: This study aims to: Investigate the effect of exercise-based task-oriented circuit training on gait kinematics including (Stride length, step length, cadence, walking speed, ankle dorsiflexion angle in initial contact, knee extension angle in midstance and hip extension angle in terminal stance) in children with hemiplegic CP. Determine the effect of task-oriented circuit training on pelvic symmetry including (Anterior and lateral pelvic tilting) in children with hemiplegic CP. Examine the effect of task-oriented circuit training on trunk endurance including (prone plank test, timed partial curl up test, front abdominal power test and unilateral supine bridge test) in children with hemiplegic CP.
Detailed Description
Children with CP have lowered physical fitness levels because their motor impairments restrict their participation in daily physical activities. Children with hemiplegic CP may experience a variety of concomitant health conditions including, movement difficulty, postural and balance instability, muscle spasticity, difficulty with motor planning and control, and cognitive impairments. They also have diminished force generation, debilitated proprioception around the core, lack of enough harmonization in core musculature, and diminished capacity to adjust coupling between the trunk, pelvis, and hip stabilizers leading to diminished proficiency of movement. According to the concept of motor learning, training is considered to be most effective when the training task is specific to the intended outcome, as optimal improvement in function involves the practice of task-specific activities. Due to the shift in focus on functional movements rather than muscle activity or movement patterns, there has been a task-oriented approach which is based on the system model of motor control providing motivation due to specific achievements that can be made. Task-oriented circuit training effectively provides various sensory stimulation and promotes functional activities for stroke patients; however, more attention is becoming directed to children with CP to examine the effect of the task-oriented circuit training program on functional performance in children with CP. Therefore, the aim of this study is to determine the effect of rehabilitation delivered as a task-oriented circuit exercise program on kinematic parameters of gait, pelvic symmetry, and trunk endurance in children with hemiplegic CP.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Spastic
Keywords
hemiplegic cerebral palsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
two different groups received different interventions at the same time
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Selected Physical Therapy group
Arm Type
Active Comparator
Arm Description
will receive a selected physical therapy program for 90 minutes, 3 times/week for 3 successive months.
Arm Title
Task-oriented circuit training group
Arm Type
Experimental
Arm Description
Children allocated to the study group will receive the same selected physical therapy program given to the control group for 45 minutes in addition to 45 minutes task-oriented circuit training program. The frequency of the whole program will be three times per week, for three months.
Intervention Type
Other
Intervention Name(s)
Task-oriented circuit training
Intervention Description
The task-oriented circuit training program consisted of 14 workstations. Time spent at each station will be 1.5 minutes. The children will complete the activity at one station and move to another station. The whole circuit will be completed in 21 minutes and it will be repeated twice per session with 3 minutes rest interval between the 2 circuits. Children will be encouraged to work as hard as possible at each workstation and will also be given verbal feedback and instructions aimed at improving performance. The progression of the task will be considered according to each child's ability and progressed as tolerated. Progressions include increasing the number of repetitions and increasing complexity of the exercise performed at each workstation, such as the distance reached in standing, reducing the height of the chair during sit-to stand, changing the height of blocks or by increasing speed of movement.
Intervention Type
Other
Intervention Name(s)
Selected Physical therapy program
Intervention Description
Facilitation of balance reactions from standing position including; standing on one leg, weight shifting from standing position, stoop and recover from standing, squat from standing and standing on balance board. Facilitation of counterpoising mechanism through instructing the child to kick ball from standing position as well as catching and throwing ball with his hands. Gait training activities including: walking using different obstacles (rolls, wedges, stepper) and walking up and down stairs. Facilitation of protective reaction from standing position by pushing the child in different directions. Facilitation of rising mechanism through changing position as well as returning back to the original position e.g.: from lying to standing and from sitting to standing. Strengthening exercises for back and abdominal muscles as well as upper and lower limbs. Jumping in place and jumping a board.
Primary Outcome Measure Information:
Title
Assessing the change in Angular displacement of joints during gait cycle
Description
assessment via using 2D gait analysis by Kinovea software in order to measure change in angular displacement of joints during gait cycle including: angle of ankle dorsiflexion at initial contact, angle of knee extension at midstance and angle of hip extension during terminal stance. All of these measurements have the same unit which is (angle in degrees)
Time Frame
at baseline and after 3 months of intervention
Title
Assessing the change in Pelvic symmetry
Description
by using palpation meter inclinometer to measure the change in anterior and lateral pelvic tilting angles in degrees
Time Frame
at baseline and after 3 months of intervention
Title
Assessing the change in spatial parameters of gait
Description
assessment via using 2D gait analysis by Kinovea software in order to measure change in step length and stride length in centimeters.
Time Frame
at baseline and after 3 months of intervention
Title
Assessing the change in Temporal parameters of gait
Description
assessment via using 2D gait analysis by Kinovea software in order to measure change in cadence (number of steps/minute) and walking speed (meter/minute)
Time Frame
at baseline and after 3 months of intervention
Secondary Outcome Measure Information:
Title
Assessing the change in Trunk muscles endurance
Description
Endurance of the trunk muscles will be evaluated using four endurance tests designed to establish the change in isometric trunk muscles endurance including; prone plank test (sec), timed partial curl up test (sec), front abdominal power test (cm) and unilateral supine bridge test (sec). For each trunk endurance measure, the examiner will instruct the child to hold the test position as long as possible prior to all testing. Each position will be tested three times and the average time will be recorded.
Time Frame
at baseline and after 3 months of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Their age will be ranged from 7-10 years. Their motor function will be at level I and II according to Gross Motor Function Classification System GMFCS (Palisano et al., 2008). The degree of spasticity will range from mild to moderate according to Modified Ashworth Scale (Bohannon and Smith, 1987). They will be able to follow instructions during evaluation and treatment. Exclusion Criteria: Children will be excluded from the study if they have: Other types of cerebral palsy. Cardiovascular or respiratory disorders. Botulinium muscular injection in the last 6 months Surgical interference in lower limbs and/or spine. Muscloskeletal problems or fixed deformities in the spine and/or lower extremities. seizures. Visual or hearing impairment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed El-Sayed, Assistant lecturer
Organizational Affiliation
Horus University in Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Outpatient clinic, Faculty of Physical Therapy, Cairo University
City
Cairo
ZIP/Postal Code
34518
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Task-oriented Circuit Training on Gait Kinematics, Pelvic Symmetry and Endurance in Children With Hemiplegia

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