Cerebral PalsyNCT00292786
The Effects of Electrical Stimulation Gait Training on Walking and Posture for Children With Cerebral Palsy
A study testing Walking Practice with Functional Electrical Stimulation and Walking Practice in people with Cerebral Palsy, run by Shriners Hospitals for Children at 1 site in United States.
Trial summary
This proposal is designed to achieve the following specific aims and will test the associated hypotheses: AIM 1: To compare walking ability, standing posture, gait initiation and functional standing and stepping of twenty children with typical development to that of twenty children with spastic diplegia or hemiplegia… Read more about this study
- Who is it for?
- Ages 7 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Walking Practice with Functional Electrical Stimulation and Walking Practice
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Jan 2008
- 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 7 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- A diagnosis of spastic diplegia or spastic hemiplegia or a history of typically development for the measurement only group.
- A Level I, II or III gross motor function classification.
- The subject classified as Level I or II is able to walk indoors and outdoors and climb stairs holding onto a railing but experiences limitations walking in crowds or confined spaces. Subjects classified as Level III's need to walk with assistive devices and have limitations in their ability to ambulate outdoors and in the community. Children have at best only minimal ability to perform gross motor skills such as running and jumping.
- Male or female between the ages of 7 and 14 years of age.
- Family able and willing to provide adequate care to electrodes and electrode sites.
- Must be orthopedically cleared without imminent risk of hip subluxation or dislocation and no significant scoliosis.
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- Seizure-free.
- Visuoperceptual skills and cognitive/communication skills sufficient to follow multiple step commands and to attend to tasks associated with data collection.
- Absence of severe tactile hypersensitivity in the lower extremities.
- Willingness to stay in Philadelphia for extended period of time to train and return for follow-up data.
- Written, informed consent.
- One year post soft tissue releases to the lower extremities.
- Passive range of motion of lower extremity joints: <10 degrees contracture of hip in extension as measured by the Thomas Test; <5 degrees knee flexion contracture and popliteal angle <45 degrees; at least 0 degrees of ankle dorsiflexion with knee extended and foot in varus.
Who cannot join
- Children with "mixed" types of CP (ie:Athetosis) or other movement disorders (ie:Ataxia).
- Allergy or sensitivity to non-latex tape placed in the skin
- Female children cannot be pregnant. A pregnancy test will be given if it is possible that the child can become pregnant, to ascertain whether or not the child is pregnant.
Trial locations and contacts
1 site in 1 country.
United States1 site
Shriners Hospital for Children Philadelphia
Philadelphia, Pennsylvania, 19140
About this study
Official title: Electrical Stimulation Gait Training to Effect Improvements in Walking Function and Posture for Children With Cerebral Palsy
This proposal is designed to achieve the following specific aims and will test the associated hypotheses:
AIM 1: To compare walking ability, standing posture, gait initiation and functional standing and stepping of twenty children with typical development to that of twenty children with spastic diplegia or hemiplegia, CP.
Read more
Hypotheses
- Children with CP will demonstrate impaired coordination as compared to children of typical development. In addition, children with CP will demonstrate inappropriate foot contact area, decreased velocity and step length as compared to children of typical development.
- Children with CP will demonstrate impaired postural control as compared to children of typical development.
- Children with CP will demonstrate an impaired gait initiation motor program as compared to children with typical development.
- Children with CP will take more time to complete the timed up and go test and demonstrate decreased reaching distances in the functional reach test as compared to children of typical development.
AIM 2: Using a single-blinded, randomized, controlled study design, to assess the ability of a 12-week at-home electrical stimulation gait training program to improve walking ability, standing posture, gait initiation, functional standing and stepping, and satisfaction with walking ability for a group of 10 children with spastic diplegia or hemiplegia CP as compared to a group of 10 children with spastic diplegia or hemiplegia CP who undergo a 12-week at-home gait training program without electrical stimulation.
Hypotheses
- The ES gait training group will demonstrate improved joint coordination as compared to the group undergoing a gait training program without ES. The ES gait training group will demonstrate improved foot contact area, increased self-selected walking velocity and greater step length as compared to the group undergoing a gait training program without ES.
- The ES gait training group will demonstrate improved postural control as compared to the group undergoing a gait training program without ES.
- The ES gait training group will demonstrate improved gait initiation as compared to the gait training group without ES.
- The ES gait training group will demonstrate decreased times on the Timed Up and Go and an increase in functional reach as compared to the group undergoing a gait training program without ES.
- The ES gait training group will demonstrate greater satisfaction and self-perceived performance on everyday tasks related to walking function and posture as measured by the COPM compared to the group that undergoes a gait training program without ES.
Read the detailed description
This is a single blinded, randomized, controlled pre-test/post-test study design (Figure 4). The twenty children with spastic diplegia or hemiplegia CP will be randomized by a statistician to one of two treatment groups. One group will undergo a 12-week at-home gait training program with ES, subjects/guardians can choose either the surface or percutaneous stimulation subgroup, and the second group will undergo a 12-week at-home gait training program without ES. For both groups, data will be collected at five points: just before gait training, after 4 and 8 weeks of gait training, at the conclusion of gait training (after 12 weeks), and 4 weeks after gait training has been discontinued (16 weeks post initiation of gait training). Data collection at each follow-up point will include the kinetics and kinematics of walking, standing posture, gait initiation, plantar pressures, the administration of the Timed Up \& Go and Functional Reach Test, and the assessment of lower extremity muscle strength using a hand-held dynamometer. The Canadian Occupational Performance Measure (COPM) will be applied before and after the 12-week gait training program and 4 weeks after the gait training has been discontinued. For the 20 children with typical development, the same data will be collected (except for the COPM) and used for comparison to the pre-training data collected from all 20 children with CP.
- Conditions
- Cerebral Palsy
- Being tested
- Walking Practice with Functional Electrical Stimulation, Walking Practice
- Keywords
- Functional Electrical Stimulation, FES, Walking, Practice, Coordination, Posture
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking Practice with Functional Electrical StimulationBehavioural
Walking PracticeBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Kinematics, Spatial Temporal Parameters &Interjoint coordination, Standing Center of Pressure Variables, Canadian Occupational Performance Measurement, Muscle activation and timing, Timed up and go test, Functional Reach test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2006 (estimated)
- Study startJun 2005
- Primary completionJan 2008
- Study completionJan 2008
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
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shriners Hospitals for Children
- Sponsor type
- University, hospital or other
- Investigators
- James J McCarthy, MD, Principal investigator, Shriners Hospital for Children PhiladelphiaCarole A Tucker, PhD, PT, Study director, Shriners Hospital Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00292786
- Sponsor's protocol ID
- 8520
- Other IDs
- 4365
- Status last verified
- Feb 2008
- First submitted
- 15 Feb 2006
- Last updated
- 5 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Stimulation Gait Training to Effect Improvements in Walking Function and Posture for Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT00292786
- Acronym / sponsor ID
- 8520
- Conditions
- Cerebral Palsy
- Keywords
- Functional Electrical Stimulation, FES, Walking, Practice, Coordination, Posture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shriners Hospitals for ChildrenUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 16 Feb 2006 (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.
This proposal is designed to achieve the following specific aims and will test the associated hypotheses:
AIM 1: To compare walking ability, standing posture, gait initiation and functional standing and stepping of twenty children with typical development to that of twenty children with spastic diplegia or hemiplegia, CP.
Hypotheses
- Children with CP will demonstrate impaired coordination as compared to children of typical development. In addition, children with CP will demonstrate inappropriate foot contact area, decreased velocity and step length as compared to children of typical development.
- Children with CP will demonstrate impaired postural control as compared to children of typical development.
- Children with CP will demonstrate an impaired gait initiation motor program as compared to children with typical development.
- Children with CP will take more time to complete the timed up and go test and demonstrate decreased reaching distances in the functional reach test as compared to children of typical development.
AIM 2: Using a single-blinded, randomized, controlled study design, to assess the ability of a 12-week at-home electrical stimulation gait training program to improve walking ability, standing posture, gait initiation, functional standing and stepping, and satisfaction with walking ability for a group of 10 children with spastic diplegia or hemiplegia CP as compared to a group of 10 children with spastic diplegia or hemiplegia CP who undergo a 12-week at-home gait training program without electrical stimulation.
Hypotheses
- The ES gait training group will demonstrate improved joint coordination as compared to the group undergoing a gait training program without ES. The ES gait training group will demonstrate improved foot contact area, increased self-selected walking velocity and greater step length as compared to the group undergoing a gait training program without ES.
- The ES gait training group will demonstrate improved postural control as compared to the group undergoing a gait training program without ES.
- The ES gait training group will demonstrate improved gait initiation as compared to the gait training group without ES.
- The ES gait training group will demonstrate decreased times on the Timed Up and Go and an increase in functional reach as compared to the group undergoing a gait training program without ES.
- The ES gait training group will demonstrate greater satisfaction and self-perceived performance on everyday tasks related to walking function and posture as measured by the COPM compared to the group that undergoes a gait training program without ES.
Detailed description
This is a single blinded, randomized, controlled pre-test/post-test study design (Figure 4). The twenty children with spastic diplegia or hemiplegia CP will be randomized by a statistician to one of two treatment groups. One group will undergo a 12-week at-home gait training program with ES, subjects/guardians can choose either the surface or percutaneous stimulation subgroup, and the second group will undergo a 12-week at-home gait training program without ES. For both groups, data will be collected at five points: just before gait training, after 4 and 8 weeks of gait training, at the conclusion of gait training (after 12 weeks), and 4 weeks after gait training has been discontinued (16 weeks post initiation of gait training). Data collection at each follow-up point will include the kinetics and kinematics of walking, standing posture, gait initiation, plantar pressures, the administration of the Timed Up \& Go and Functional Reach Test, and the assessment of lower extremity muscle strength using a hand-held dynamometer. The Canadian Occupational Performance Measure (COPM) will be applied before and after the 12-week gait training program and 4 weeks after the gait training has been discontinued. For the 20 children with typical development, the same data will be collected (except for the COPM) and used for comparison to the pre-training data collected from all 20 children with CP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- A diagnosis of spastic diplegia or spastic hemiplegia or a history of typically development for the measurement only group.
- A Level I, II or III gross motor function classification.
- The subject classified as Level I or II is able to walk indoors and outdoors and climb stairs holding onto a railing but experiences limitations walking in crowds or confined spaces. Subjects classified as Level III's need to walk with assistive devices and have limitations in their ability to ambulate outdoors and in the community. Children have at best only minimal ability to perform gross motor skills such as running and jumping.
- Male or female between the ages of 7 and 14 years of age.
- Family able and willing to provide adequate care to electrodes and electrode sites.
Key exclusion criteria (3 listed)
- Children with "mixed" types of CP (ie:Athetosis) or other movement disorders (ie:Ataxia).
- Allergy or sensitivity to non-latex tape placed in the skin
- Female children cannot be pregnant. A pregnancy test will be given if it is possible that the child can become pregnant, to ascertain whether or not the child is pregnant.
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 |
|---|---|---|
| Walking Practice with Functional Electrical Stimulation | Behavioural | – |
| Walking Practice | Behavioural | – |
Primary outcome
Gait Kinematics, Spatial Temporal Parameters &Interjoint coordination, Standing Center of Pressure Variables, Canadian Occupational Performance Measurement, Muscle activation and timing, Timed up and go test, Functional Reach test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2008.
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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.
James J McCarthy, MD principal investigator
Shriners Hospital for Children Philadelphia
Carole A Tucker, PhD, PT study director
Shriners Hospital Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking Practice with Functional Electrical Stimulation and Walking Practice in people with Cerebral Palsy, run by Shriners Hospitals for Children at 1 site 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 3 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: finished, as of the sponsor's last update on 5 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Kinematics, Spatial Temporal Parameters &Interjoint coordination, Standing Center of Pressure Variables, Canadian Occupational Performance Measurement, Muscle activation and timing, Timed up and go test, Functional Reach test. 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 5 Feb 2008.