Cerebral PalsyNCT01657994
Combined Functional Electrical Stimulation & Robotic Gait Training for Children With Cerebral Palsy
A study testing Combined functional electrical stimulation and robotic gait training in people with Cerebral Palsy, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The purpose of this research study is to learn more about the usefulness of a physical therapy treatment that combines robot-assisted walking with electrical impulses that help to make muscles contract. This treatment is intended for children with cerebral palsy. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Combined functional electrical stimulation and robotic gait training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Sep 2013
- 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- GMFCS II, III, or IV cerebral palsy
- 5-12 years of age
- meet safety criteria for robotic gait training (<300 lbs, intact skin, femoral length 21-47 cm, ability to follow simple instructions)
- meet safety criteria for functional electrical stimulation (voluntary hip and knee muscle contraction, intact skin)
Who cannot join
- planned major intervention during study period
- contractures that interfere with upright stance
- history of non-traumatic long bone fracture or clinically significant osteoporosis
- significant concurrent illness
- significant condition not typically associated with cerebral palsy
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
The purpose of this research study is to learn more about the usefulness of a physical therapy treatment that combines robot-assisted walking with electrical impulses that help to make muscles contract. This treatment is intended for children with cerebral palsy. Up to eleven children with cerebral palsy will receive up to 18 treatments and will have several evaluations before and after treatment.
- Conditions
- Cerebral Palsy
- Being tested
- Combined functional electrical stimulation and robotic gait training
- Keywords
- cerebral palsy, gait training, robotic, functional electrical stimulation
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined functional electrical stimulation and robotic gait trainingOther
Also called Lokomat, RT-50
up to 18 sessions of approximately 45 minutes occurring over up to 9 weeks
| Study group | Role | What they receive |
|---|---|---|
| therapy plus fes | Experimental | robotic gait training plus functional electrical stimulation Receives: Other: Combined functional electrical stimulation and robotic gait training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gross Motor Function Measure-66 using multiple baseline assessments
Measured: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
Secondary outcomes (9)
Change in strength via myometry
Measured: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
Change in Observational Gait Scale
Measured: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
Change in Modified Ashworth Scale
Measured: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
Change in Goniometry at the knee
Measured: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
Change in 6 minute walk
Measured: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
Change in 10 meter walk
Measured: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
Change in Children's Assessment of Participation and Enjoyment
Measured: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
Change in Cerebral Palsy Quality of Life Questionnaire
Measured: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
Change in Canadian Occupational Performance Measure
Measured: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2012 (estimated)
- Study startMay 2012
- Primary completionJul 2013
- Study completionSep 2013
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Cerebral Palsy International Research Foundation
- Responsible party
- Sponsor
- Investigators
- Jilda Vargus-Adams, MD MSc, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01657994
- Sponsor's protocol ID
- R-796-10
- Status last verified
- Aug 2016
- First submitted
- 17 May 2012
- Last updated
- 1 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Functional Electrical Stimulation & Robotic Gait Training for Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT01657994
- Acronym / sponsor ID
- R-796-10
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, gait training, robotic, functional electrical stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Cerebral Palsy International Research Foundation
- Study start
- May 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 6 Aug 2012 (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 purpose of this research study is to learn more about the usefulness of a physical therapy treatment that combines robot-assisted walking with electrical impulses that help to make muscles contract. This treatment is intended for children with cerebral palsy. Up to eleven children with cerebral palsy will receive up to 18 treatments and will have several evaluations before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| therapy plus fes | Experimental | Other: Combined functional electrical stimulation and robotic gait trainingrobotic gait training plus functional electrical stimulation |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- GMFCS II, III, or IV cerebral palsy
- 5-12 years of age
- meet safety criteria for robotic gait training (<300 lbs, intact skin, femoral length 21-47 cm, ability to follow simple instructions)
- meet safety criteria for functional electrical stimulation (voluntary hip and knee muscle contraction, intact skin)
Key exclusion criteria (5 listed)
- planned major intervention during study period
- contractures that interfere with upright stance
- history of non-traumatic long bone fracture or clinically significant osteoporosis
- significant concurrent illness
- significant condition not typically associated with cerebral palsy
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 |
|---|---|---|
| Combined functional electrical stimulation and robotic gait trainingAlso: Lokomat, RT-50up to 18 sessions of approximately 45 minutes occurring over up to 9 weeks | Other | therapy plus fes |
Primary outcome
Change in Gross Motor Function Measure-66 using multiple baseline assessments
Time frame: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
9 secondary outcomes
Change in strength via myometry
Time frame: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
Change in Observational Gait Scale
Time frame: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
Change in Modified Ashworth Scale
Time frame: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
Change in Goniometry at the knee
Time frame: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
Change in 6 minute walk
Time frame: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
Change in 10 meter walk
Time frame: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
Change in Children's Assessment of Participation and Enjoyment
Time frame: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
Change in Cerebral Palsy Quality of Life Questionnaire
Time frame: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
Change in Canadian Occupational Performance Measure
Time frame: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment
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 1 Sep 2016.
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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.
Jilda Vargus-Adams, MD MSc principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined functional electrical stimulation and robotic gait training in people with Cerebral Palsy, run by Children's Hospital Medical Center, Cincinnati 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 4 inclusion and 5 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 1 Sep 2016. 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?
Change in Gross Motor Function Measure-66 using multiple baseline assessments (time frame: 4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment). 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 1 Sep 2016.