Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00467415
Status:
UNKNOWN
Last Update Posted:
2009-06-29
First Post:
2007-04-27
Brief Title:
Supported Speed Treadmill Training Exercise Program SSTTEP for Marginally Ambulatory Children With Cerebral Palsy
Sponsor:
Shriners Hospitals for Children
Organization:
Shriners Hospitals for Children
Study Overview
Official Title:
Multi-Center Project Supported Speed Treadmill Training Exercise Program SSTTEP for Marginally Ambulatory Children With Cerebral Palsy
Status:
UNKNOWN
Status Verified Date:
2008-08
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SSTTEP
Brief Summary:
The investigators are studying the effects of a 12-week exercise program consisting of either
1 Walking on a treadmill with partial body weight
2 Functional exercise program
The investigators would like to know the effects these two exercise programs have on the quality of life muscle strength and control coordination walking and functional movement of children with cerebral palsy who are marginal ambulators This is a randomized control trial with subjects randomly assigned to one of the 2 groupsSubjects in both groups will be seen twice a day for two weeks at our hospital for intervention and parent training and then participate in a 10 week home-based program During each subjects two-week clinic-based training a parent or caregiver is trained in all home program exercises andor equipment usage This person must be able to safely perform the exercise program with the child Each subject will also need to participate in three separate 5-hour long data collection sessions scheduled over the 4 month study period
1 Walking on a treadmill with partial body weight
2 Functional exercise program
The investigators would like to know the effects these two exercise programs have on the quality of life muscle strength and control coordination walking and functional movement of children with cerebral palsy who are marginal ambulators This is a randomized control trial with subjects randomly assigned to one of the 2 groupsSubjects in both groups will be seen twice a day for two weeks at our hospital for intervention and parent training and then participate in a 10 week home-based program During each subjects two-week clinic-based training a parent or caregiver is trained in all home program exercises andor equipment usage This person must be able to safely perform the exercise program with the child Each subject will also need to participate in three separate 5-hour long data collection sessions scheduled over the 4 month study period
Detailed Description:
This project proposes to answer the following questions Is partial body weight supported treadmill gait training PBWSTT effective in improving ambulation abilities neuromuscular impairments functional mobility disability and quality of life in marginally ambulatory children with cerebral palsy
Specific Aim 1 Assess the effect of a PBWSTT locomotor training intervention on quality of life treatment expectations self-efficacy and activity and participation of children with CP with limited ambulation skills We hypothesize that in comparison to a control group after a 12 week locomotor intervention children with CP intervention group with limited ambulation skills will demonstrate greater improvements in scores from common questionnaires compared to the control group
Specific Aim 2 Assess the effect of a PBWSTT locomotor training intervention on gross motor skills physical function biomechanics and coordination dynamics of ambulation and physical activity in ambulatory children with CP We hypothesize that in comparison to a control group after a 12 week PBWSTT locomotor training intervention children with CP with limited ambulation skills will demonstrate greater improvements in functional test scores compared to the control group
Specific Aim 3 Assess the effect of a PBWSTT locomotor training intervention on measures of body structure and function including spasticity muscle strength and joint-specific motor control We hypothesize that in comparison to a control group after a 12 week PBWSTT locomotor training intervention children with CP with limited ambulation skills will demonstrate greater improvements in muscle strength spasticity and joint specific motor control compared to the control group
This is a single blinded randomized controlled pre-testpost-test study design Sixty six ambulatory children between the ages of 6-12 years of age with cerebral palsy will undergo a 12-week training program Thirty three of these children will undergo a Supported Speed Treadmill Training Exercise Program SSTTEP and the remaining 33 children will receive the same amount of conventional physical therapy in the form of a personalized home exercise program and serve as a control group Three sets of measures will be obtained A1 at baseline prior to intervention A2 at the end of the 12-week intervention period and A3 4 weeks after the intervention has ended
The two primary aims of our study are to assess the efficacy of SSTTEP in improving quality of life functional ambulation energy expenditure gross motor skills and muscle strength and tone and to assess the efficacy of SSTTEP in improving the coordination of stepping and ambulation in children with CP
The intervention group will undergo a program of 10 hours of intensive SSTTEP training over a 14 day period After the initial training the subjects will participate in a home program of 30 minutes5 times per week for an additional 10 weeks
The control group with undergo a personalized exercise program consisting of 10 hours of intensive training over a 14 day period After the initial training the subjects will participate in a home program of 30 minutes5 times per week for an additional 10 weeks
Specific Aim 1 Assess the effect of a PBWSTT locomotor training intervention on quality of life treatment expectations self-efficacy and activity and participation of children with CP with limited ambulation skills We hypothesize that in comparison to a control group after a 12 week locomotor intervention children with CP intervention group with limited ambulation skills will demonstrate greater improvements in scores from common questionnaires compared to the control group
Specific Aim 2 Assess the effect of a PBWSTT locomotor training intervention on gross motor skills physical function biomechanics and coordination dynamics of ambulation and physical activity in ambulatory children with CP We hypothesize that in comparison to a control group after a 12 week PBWSTT locomotor training intervention children with CP with limited ambulation skills will demonstrate greater improvements in functional test scores compared to the control group
Specific Aim 3 Assess the effect of a PBWSTT locomotor training intervention on measures of body structure and function including spasticity muscle strength and joint-specific motor control We hypothesize that in comparison to a control group after a 12 week PBWSTT locomotor training intervention children with CP with limited ambulation skills will demonstrate greater improvements in muscle strength spasticity and joint specific motor control compared to the control group
This is a single blinded randomized controlled pre-testpost-test study design Sixty six ambulatory children between the ages of 6-12 years of age with cerebral palsy will undergo a 12-week training program Thirty three of these children will undergo a Supported Speed Treadmill Training Exercise Program SSTTEP and the remaining 33 children will receive the same amount of conventional physical therapy in the form of a personalized home exercise program and serve as a control group Three sets of measures will be obtained A1 at baseline prior to intervention A2 at the end of the 12-week intervention period and A3 4 weeks after the intervention has ended
The two primary aims of our study are to assess the efficacy of SSTTEP in improving quality of life functional ambulation energy expenditure gross motor skills and muscle strength and tone and to assess the efficacy of SSTTEP in improving the coordination of stepping and ambulation in children with CP
The intervention group will undergo a program of 10 hours of intensive SSTTEP training over a 14 day period After the initial training the subjects will participate in a home program of 30 minutes5 times per week for an additional 10 weeks
The control group with undergo a personalized exercise program consisting of 10 hours of intensive training over a 14 day period After the initial training the subjects will participate in a home program of 30 minutes5 times per week for an additional 10 weeks
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