Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06603636
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-07
Brief Title:
FOOT PROGRESSION ANGLE in RELATION to SPATIOTEMPORAL PARAMETERS of GAIT in CHILDREN with CEREBRAL PALSY
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Study Aim to Assess Foot Progression Angles in Diplegic Children Age Ranged from 5 to 8 Years Also Spatiotemporal Parameters of Gait for Them and If a Relation Between Foot Progression Angle and Spatiotemporal Parameters of Gait of Them
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study was applied to assess the difference of the foot progression angle and measuring spatiotemporal parameters of gait among the three age groups five to six six to seven and seven to eight years of diplegic cerebral palsied children and to investigate the relation between FPA of right and left lower extremity and spatiotemporal parameters of gait in diplegic cerebral palsied children
Sixty diplegic cerebral palsied children from both sexes with age ranged from five to eight years old were participated in this study
Children were selected from the outpatient clinic of faculty of physical therapy Cairo University
They were divided into three equal age groups group A from five to six years group B from six to seven years and group C from seven to eight years
Foot progression angle and spatiotemporal parameters of gait were evaluated for each participated child by the use of dynamic footprint during walking barefoot at free walking speed
Sixty diplegic cerebral palsied children from both sexes with age ranged from five to eight years old were participated in this study
Children were selected from the outpatient clinic of faculty of physical therapy Cairo University
They were divided into three equal age groups group A from five to six years group B from six to seven years and group C from seven to eight years
Foot progression angle and spatiotemporal parameters of gait were evaluated for each participated child by the use of dynamic footprint during walking barefoot at free walking speed
Detailed Description:
Introduction Cerebral palsy CP is the most common pediatric neurological and physical disability It is a group of permanent disorders of the development of movement and posture that are attributed to non-progressive disturbances that occurred in the developing fetal or infant brain along with accompanying conditions such as mental retardation epilepsy perceptual impairment language impairment and mental behavior abnormalities
Foot progression angle FPA is defined as the angle between the longitudinal axis of the foot and the line of progression of the childs gait It represents the rotational gait deviation of the lower extremity from the tip of the femoral head to the foot It was also defined as the angle of the foot relative to the progressive direction of the subjects during gait
Abnormal gait is a common problem in children with CP Because of motor weakness and poor voluntary motor control crouched gait or diplegic gait is an important functional biomarker in children with spastic diplegic CP In addition gait in children with CP is characterized by a slower walking speed a shorter-stride length and more time spent in double support
Purpose of the Study The purpose of the study is
To determine the side differences right and left sides on FPA values in diplegic CP children from five to eight years
To measuring spatiotemporal parameters of gait in diplegic CP children from five to eight years
To investigate the interrelationship between FPA and spatiotemporal parameters diplegic CP children from five to eight years
Subjects Instrumentations and Procedures
Subjects
Sixty diplegic andor hemiplegic CP children will participate in this study They will be selected from both sexes Subjects will be selected from the outpatient clinic of Faculty of Physical Therapy Cairo University according to the following criteria
Inclusion criteria
Their age will be ranged from six to eight years
Children diagnosed as diplegic andor hemiplegic CP
Children who can stand and ambulate without the use of an assistive device At Level II or III on the Gross Motor Function Classification System
Their degree of spasticity will be ranged from 1 to 1 according to the Modified Ashworth Scale
Children who are able to follow instructions and understand commands given to them during the testing procedure
Dynamic foot print will be used to assess FPA and spatial parameter of gait step length and stride length
Exclusion criteria
Children with Convulsions
Children with fixed contractures of lower extremities
Children with surgical interventions in the lower extremities
Children with visual andor auditory disorders
Instrumentation materials
The main used equipment and tools
1 Modified Ashworth Scale will be used to determine the degree of spasticity
2 Gross Motor Function Classification System will be used to determine children who can stand and ambulate without the use of an assistive device
3 Dynamic Footprint Dynamic footprint will be used to measure FPA and spatial parameters of gait The materials were used for measurement and analyses of FPA Losel et al 1996 were
A walkway of 6 m length 61 cm width and 5 mm height
Paper of 610 cm by 457 cm 20 ft 15 ft to be placed on the walkway
Adhesive tape to stabilize the paper on the walkway
One chair at each end of the paper
Tray 1 cm depth large enough to accommodate both feet
Colored powder paint and talcum powder 1001
Two wet towels
Towel and wet wipes for cleansing feet placed at far end
Artist fixatives spray to be sprayed over successive footprints in order to prevent smudging of the prints
Adhesive transparent contact plastic to be placed over each individual footprint
Scissor for cutting the adhesive tape used to stabilize the paper
Transparent grid parallel lines
Fine 05 mm water soluble pen non-permanent marker
Two stainless steel rulers one 30 cm and the other one meter length
Transparent plastic protractor
Procedures of the study
Subjects recruitment Before recruitment a talk will be given by the researcher to parents to explain the purposes and methodology of the study The consent forms will then be given to childrenamp parents After collecting the consent forms subjects will be examined by the researcher for the inclusion and exclusion criteria Each eligible child according to the consent form and examination will participate in the study
The protocol of the study will be explained to the subjects before conducting the study
Dynamic Footprint Procedure
1 For measuring FPA
This procedure will be classified into two main phases
-- --
1 Measurement phase
- Footprint data will be obtained using 6 m lengths of white paper 45 cm wide for each trail
- The paper will be laid out over an elevated walkway 6 m in length and 5 mm above the floor
- All lining paper will be affixed with adhesive tape to prevent any slippage during data collection
- A chair will be positioned at either end of the paper
- The child will not be distracted by anything in the room which may change the motion pattern
- Each child will be standing bare-feet and was allowed to walk over the walkway several times to familiarize himselfherself with the procedure
- A wet towel will be placed at the base of the chair at both ends
- A tray 1 cm depth large enough to contain both feet containing a composite mixture of colored powder paint and talcum powder 1001 at the base of the chair at the starting end was used to generate the footprints to be analyzed
Each child will be instructed to place both feet on a wet towel then to place them in a tray Excess powder was gently shaken off
The container will be removed and the child was instructed to rise from the chair and walk at free walking speed to the other end looking straight ahead and sit down upon reaching the other end for cleansing feet by wet wipes and towel
Once adequate footprint will be obtained four successive mid-gait analysis footprints will be identified to exclude phases of acceleration and deceleration and will be sprayed with artists fixative spray in order to prevent smearing of the print and then left to dry
Once dry a piece of adhesive transparent contact plastic will be placed over each individual footprint before the 6 m length of paper was rolled up
All trails will be laminated to facilitate repeated measurements
Each childs name will be written in each paper
2 Analysis phase
- The first few steps of the footprints were generally disregarded because they were initiated from a static position and were therefore not indicative of the subjects steps during active locomotion
- A fine 05 mm water-soluble pen was used which enabled marks to be erased and didn39t leave any indentations on the laminated surface
- Stainless-steel rulers were used to draw lines and angles were measured with a transparent plastic protractor enabling measurement increments to 05
- A transparent grid a simple rectangle made up of parallel lines was placed over the footprint
- The longitudinal border of the grid was aligned with the apex of the hallux and the medial side of the forefoot To ensure parallel placement of the grid the distance between the top and bottom margins of the grid and the border of the paper were measured
- The grid was used to draw a line A representing the apex of the hallux Figure 2 A similar line B was drawn at the posterior aspect of the heel that was parallel to the line A dividing the length of the foot into three equal portions and creating lines C and D Shores 1980
The length of line C forefoot reference and D rear foot reference was measured using the outer borders of the print each line was bisected and thus midpoints will be determined
The medial and lateral borders of the entire footprint were defined by constructing two lines
1 The most medial aspect of the forefoot disregarding the toes was marked as was the most medial aspect of the heel These points were connected by a line to establish the medial border of the print
2 The most lateral border of the forefoot again disregarding the toes was marked as was the most lateral border of the heel These points were connected to establish a lateral border of the print
The study was applied to assess the difference of the foot progression angle and measuring spatiotemporal parameters of gait among the three age groups five to six six to seven and seven to eight years of diplegic cerebral palsied children and to investigate the relation between FPA of right and left lower extremity and spatiotemporal parameters of gait in diplegic cerebral palsied children
Sixty diplegic cerebral palsied children from both sexes with age ranged from five to eight years old were participated in this study
Children were selected from the outpatient clinic of faculty of physical therapy Cairo University
They were divided into three equal age groups group A from five to six years group B from six to seven years and group C from seven to eight years
Foot progression angle and spatiotemporal parameters of gait were evaluated for each participated child by the use of dynamic footprint during walking barefoot at free walking speed
Foot progression angle FPA is defined as the angle between the longitudinal axis of the foot and the line of progression of the childs gait It represents the rotational gait deviation of the lower extremity from the tip of the femoral head to the foot It was also defined as the angle of the foot relative to the progressive direction of the subjects during gait
Abnormal gait is a common problem in children with CP Because of motor weakness and poor voluntary motor control crouched gait or diplegic gait is an important functional biomarker in children with spastic diplegic CP In addition gait in children with CP is characterized by a slower walking speed a shorter-stride length and more time spent in double support
Purpose of the Study The purpose of the study is
To determine the side differences right and left sides on FPA values in diplegic CP children from five to eight years
To measuring spatiotemporal parameters of gait in diplegic CP children from five to eight years
To investigate the interrelationship between FPA and spatiotemporal parameters diplegic CP children from five to eight years
Subjects Instrumentations and Procedures
Subjects
Sixty diplegic andor hemiplegic CP children will participate in this study They will be selected from both sexes Subjects will be selected from the outpatient clinic of Faculty of Physical Therapy Cairo University according to the following criteria
Inclusion criteria
Their age will be ranged from six to eight years
Children diagnosed as diplegic andor hemiplegic CP
Children who can stand and ambulate without the use of an assistive device At Level II or III on the Gross Motor Function Classification System
Their degree of spasticity will be ranged from 1 to 1 according to the Modified Ashworth Scale
Children who are able to follow instructions and understand commands given to them during the testing procedure
Dynamic foot print will be used to assess FPA and spatial parameter of gait step length and stride length
Exclusion criteria
Children with Convulsions
Children with fixed contractures of lower extremities
Children with surgical interventions in the lower extremities
Children with visual andor auditory disorders
Instrumentation materials
The main used equipment and tools
1 Modified Ashworth Scale will be used to determine the degree of spasticity
2 Gross Motor Function Classification System will be used to determine children who can stand and ambulate without the use of an assistive device
3 Dynamic Footprint Dynamic footprint will be used to measure FPA and spatial parameters of gait The materials were used for measurement and analyses of FPA Losel et al 1996 were
A walkway of 6 m length 61 cm width and 5 mm height
Paper of 610 cm by 457 cm 20 ft 15 ft to be placed on the walkway
Adhesive tape to stabilize the paper on the walkway
One chair at each end of the paper
Tray 1 cm depth large enough to accommodate both feet
Colored powder paint and talcum powder 1001
Two wet towels
Towel and wet wipes for cleansing feet placed at far end
Artist fixatives spray to be sprayed over successive footprints in order to prevent smudging of the prints
Adhesive transparent contact plastic to be placed over each individual footprint
Scissor for cutting the adhesive tape used to stabilize the paper
Transparent grid parallel lines
Fine 05 mm water soluble pen non-permanent marker
Two stainless steel rulers one 30 cm and the other one meter length
Transparent plastic protractor
Procedures of the study
Subjects recruitment Before recruitment a talk will be given by the researcher to parents to explain the purposes and methodology of the study The consent forms will then be given to childrenamp parents After collecting the consent forms subjects will be examined by the researcher for the inclusion and exclusion criteria Each eligible child according to the consent form and examination will participate in the study
The protocol of the study will be explained to the subjects before conducting the study
Dynamic Footprint Procedure
1 For measuring FPA
This procedure will be classified into two main phases
-- --
1 Measurement phase
- Footprint data will be obtained using 6 m lengths of white paper 45 cm wide for each trail
- The paper will be laid out over an elevated walkway 6 m in length and 5 mm above the floor
- All lining paper will be affixed with adhesive tape to prevent any slippage during data collection
- A chair will be positioned at either end of the paper
- The child will not be distracted by anything in the room which may change the motion pattern
- Each child will be standing bare-feet and was allowed to walk over the walkway several times to familiarize himselfherself with the procedure
- A wet towel will be placed at the base of the chair at both ends
- A tray 1 cm depth large enough to contain both feet containing a composite mixture of colored powder paint and talcum powder 1001 at the base of the chair at the starting end was used to generate the footprints to be analyzed
Each child will be instructed to place both feet on a wet towel then to place them in a tray Excess powder was gently shaken off
The container will be removed and the child was instructed to rise from the chair and walk at free walking speed to the other end looking straight ahead and sit down upon reaching the other end for cleansing feet by wet wipes and towel
Once adequate footprint will be obtained four successive mid-gait analysis footprints will be identified to exclude phases of acceleration and deceleration and will be sprayed with artists fixative spray in order to prevent smearing of the print and then left to dry
Once dry a piece of adhesive transparent contact plastic will be placed over each individual footprint before the 6 m length of paper was rolled up
All trails will be laminated to facilitate repeated measurements
Each childs name will be written in each paper
2 Analysis phase
- The first few steps of the footprints were generally disregarded because they were initiated from a static position and were therefore not indicative of the subjects steps during active locomotion
- A fine 05 mm water-soluble pen was used which enabled marks to be erased and didn39t leave any indentations on the laminated surface
- Stainless-steel rulers were used to draw lines and angles were measured with a transparent plastic protractor enabling measurement increments to 05
- A transparent grid a simple rectangle made up of parallel lines was placed over the footprint
- The longitudinal border of the grid was aligned with the apex of the hallux and the medial side of the forefoot To ensure parallel placement of the grid the distance between the top and bottom margins of the grid and the border of the paper were measured
- The grid was used to draw a line A representing the apex of the hallux Figure 2 A similar line B was drawn at the posterior aspect of the heel that was parallel to the line A dividing the length of the foot into three equal portions and creating lines C and D Shores 1980
The length of line C forefoot reference and D rear foot reference was measured using the outer borders of the print each line was bisected and thus midpoints will be determined
The medial and lateral borders of the entire footprint were defined by constructing two lines
1 The most medial aspect of the forefoot disregarding the toes was marked as was the most medial aspect of the heel These points were connected by a line to establish the medial border of the print
2 The most lateral border of the forefoot again disregarding the toes was marked as was the most lateral border of the heel These points were connected to establish a lateral border of the print
The study was applied to assess the difference of the foot progression angle and measuring spatiotemporal parameters of gait among the three age groups five to six six to seven and seven to eight years of diplegic cerebral palsied children and to investigate the relation between FPA of right and left lower extremity and spatiotemporal parameters of gait in diplegic cerebral palsied children
Sixty diplegic cerebral palsied children from both sexes with age ranged from five to eight years old were participated in this study
Children were selected from the outpatient clinic of faculty of physical therapy Cairo University
They were divided into three equal age groups group A from five to six years group B from six to seven years and group C from seven to eight years
Foot progression angle and spatiotemporal parameters of gait were evaluated for each participated child by the use of dynamic footprint during walking barefoot at free walking speed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None