Cerebral PalsySSTTEPNCT00467415
Supported Speed Treadmill Training Exercise Program (SSTTEP) for Marginally Ambulatory Children With Cerebral Palsy
A study testing Partial body weight support treadmill training and Exercise in people with Cerebral Palsy, run by Shriners Hospitals for Children at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 13 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Partial body weight support treadmill training and Exercise
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 66 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2007to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- A diagnosis of spastic cerebral palsy;
- Impaired ambulation abilities as evidenced by a decreased in gait velocity below 80% of age expected value or gross motor function classification scale (GMFCS) Level III or IV;
- Able to ambulate independently for 8 steps with/without assistive devices to allow for adequate motion analysis data collection;
- Body weight of less than 150 pounds;
- Between the ages of 6 and 13 years;
- Able to follow multiple step commands and to attend to tasks associated with data collection;
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- Willingness to travel to one of the three sites for data collection sessions, and 2 weeks of intensive intervention;
- Willingness to commit to home program 30 minutes per session, 5 times week for 10 weeks, as well as adequate space and supervision for treadmill use at home;
- No reported musculoskeletal, cardiovascular or pulmonary conditions that would limit participation in moderate exercise program;
- Minimum of 12 months post surgery including soft tissue releases
- Six months post-Botox injections, significant changes in Baclofen dosing, or casting procedures to the lower extremities;
- Passive range of motion of lower extremity joints: < 30º contracture of hip in extension as measured by the Thomas Test; passive dorsiflexion range of motion to -15º with the knee extended, and knee extension range (90º/90º test) to 70º and <-20º knee extension.
- At least 2 years post- dorsal rhizotomy.
Who cannot join
- Children with "mixed" types of CP (i.e. athetosis) or other movement disorders (e.g. ataxia);
- Children receiving intrathecal Baclofen (baclofen pump);
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Shriners Hospital for Children, Philadelphia
Philadelphia, Pennsylvania, 19140
Shriners Hospital for Children, Shreveport
Shreveport, Louisiana, 71103
Washington University
St Louis, Missouri, 63104
About this study
Official title: Multi-Center Project: Supported Speed Treadmill Training Exercise Program (SSTTEP) for Marginally Ambulatory Children With Cerebral Palsy
The investigators are studying the effects of a 12-week exercise program, consisting of either:
- Walking on a treadmill with partial body weight
- 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 groups.Subjects 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 subject's two-week clinic-based training, a parent or caregiver is trained in all home program exercises and/or 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.
Read the 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-test/post-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 minutes/5 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 minutes/5 times per week for an additional 10 weeks.
- Conditions
- Cerebral Palsy
- Being tested
- Partial body weight support treadmill training, Exercise
- Keywords
- Walking, Treadmill, Partial Weightbearing
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial body weight support treadmill trainingBehavioural
Treadmill ambulation for 12 weeks. First 2 weeks for 10 total dose hours within clinical setting, final 10 weeks with 30 min/5 times week.
ExerciseBehavioural
Functional Strengthening exercise program for 12 weeks. First 2 weeks for 10 total dose hours within clinical setting, final 10 weeks with 30 min/5 times week.
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Spatio-Temporal Parameters
Measured: 6 months
Muscle Activation and Timing
Measured: 6 months
Pediatric Quality of Life Inventory (PEDS-QL)
Measured: 6 months
Canadian Occupational Performance Measure (COPM)
Measured: 6 months
Children's Assessment of Participation and Enjoyment (CAPE)
Measured: 6 months
Piers-Harris Children's Self-Concept Scale, 2nd Edition (PHCSCS-2)
Measured: 6 months
Gross Motor Function Measure (GMFM)
Measured: 6 months
Pediatric Outcomes Data Collection Instrument (PODCI)
Measured: 6 months
Gait Velocity
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2007 (estimated)
- Study startMay 2007
- Primary completionOct 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shriners Hospitals for Children
- Sponsor type
- University, hospital or other
- Investigators
- Randal Betz, MD, Principal investigator, Shriners Hospital for Children, Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00467415
- Sponsor's protocol ID
- SHC_COSAB9147
- Acronym
- SSTTEP
- Status last verified
- Aug 2008
- First submitted
- 27 Apr 2007
- Last updated
- 29 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center Project: Supported Speed Treadmill Training Exercise Program (SSTTEP) for Marginally Ambulatory Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT00467415
- Acronym / sponsor ID
- SSTTEP / SHC_COSAB9147
- Conditions
- Cerebral Palsy
- Keywords
- Walking, Treadmill, Partial Weightbearing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Shriners Hospitals for ChildrenUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Oct 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 30 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators are studying the effects of a 12-week exercise program, consisting of either:
- Walking on a treadmill with partial body weight
- 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 groups.Subjects 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 subject's two-week clinic-based training, a parent or caregiver is trained in all home program exercises and/or 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-test/post-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 minutes/5 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 minutes/5 times per week for an additional 10 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- A diagnosis of spastic cerebral palsy;
- Impaired ambulation abilities as evidenced by a decreased in gait velocity below 80% of age expected value or gross motor function classification scale (GMFCS) Level III or IV;
- Able to ambulate independently for 8 steps with/without assistive devices to allow for adequate motion analysis data collection;
- Body weight of less than 150 pounds;
- Between the ages of 6 and 13 years;
Key exclusion criteria (2 listed)
- Children with "mixed" types of CP (i.e. athetosis) or other movement disorders (e.g. ataxia);
- Children receiving intrathecal Baclofen (baclofen pump);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Partial body weight support treadmill trainingTreadmill ambulation for 12 weeks. First 2 weeks for 10 total dose hours within clinical setting, final 10 weeks with 30 min/5 times week. | Behavioural | – |
| ExerciseFunctional Strengthening exercise program for 12 weeks. First 2 weeks for 10 total dose hours within clinical setting, final 10 weeks with 30 min/5 times week. | Behavioural | – |
Primary outcome
Gait Spatio-Temporal Parameters
Time frame: 6 months
Muscle Activation and Timing
Time frame: 6 months
Pediatric Quality of Life Inventory (PEDS-QL)
Time frame: 6 months
Canadian Occupational Performance Measure (COPM)
Time frame: 6 months
Children's Assessment of Participation and Enjoyment (CAPE)
Time frame: 6 months
Piers-Harris Children's Self-Concept Scale, 2nd Edition (PHCSCS-2)
Time frame: 6 months
Gross Motor Function Measure (GMFM)
Time frame: 6 months
Pediatric Outcomes Data Collection Instrument (PODCI)
Time frame: 6 months
Gait Velocity
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Randal Betz, MD principal investigator
Shriners Hospital for Children, Philadelphia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partial body weight support treadmill training and Exercise in people with Cerebral Palsy, run by Shriners Hospitals for Children at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait Spatio-Temporal Parameters (time frame: 6 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2009; AzTrials last refreshed its copy on 2 Nov 2026.