Spastic DiplegiaPhase 2NCT00004751
Phase II Randomized Study of Selective Dorsal Rhizotomy and Physiotherapy Vs Physiotherapy Alone for Spastic Diplegia
A Phase 2 study testing Surgery and Physical therapy in people with Spastic Diplegia, run by National Institute of Neurological Disorders and Stroke (NINDS).
Trial summary
OBJECTIVES: I. Assess the efficacy and safety of selective dorsal rhizotomy and physiotherapy compared with physiotherapy alone in improving gross motor function and reducing spasticity in children with spastic diplegia. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Spastic Diplegia
- What is being tested?
- Surgery and Physical therapy
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Oct 1991to not given
- Phase
- Phase 2
- 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
- Spastic diplegia, i.e.: Measurable spasticity with more lower than upper limb involvement
- Fair to good trunk and head control
- Little or no bulbar involvement
- Able to walk or has potential to walk indoors with assistive devices
- No fixed musculoskeletal deformity greater than 15 degrees
- Prior orthopedic surgery acceptable if spastic muscle group is in physiologic biomechanical position and retains voluntary power
- No detectable athetosis, rigidity, ataxia, or other movement disorder
- No disease-related, treatable condition that may become urgent during study, e.g., hip subluxation requiring adductor release
--Patient Characteristics--
- Age: 3 to 18
- Other: Intelligence Quotient greater than 50 Developmental age 3 years or higher
- Able to follow multi-step commands
- Expressive communication skills at 3-year level or higher
- Mild dysarthria or drooling does not exclude
- Stable social environment
- Regular school and physical therapy attendance
- Normal psychiatric status
- Guardian able to give support and follow-up care
- No medical contraindication to anesthesia or surgery, e.g.: Previous anesthesia reaction
- Chronic lung disease
- Uncontrollable seizures
- Scoliosis Vertebral anomaly
- Neural tube defect
- No visual impairment sufficient to hinder mobility
- Able to come to Children's Hospital and Medical Center for follow-up Insurance coverage adequate for surgery and postoperative physiotherapy
About this study
OBJECTIVES:
- Assess the efficacy and safety of selective dorsal rhizotomy and physiotherapy compared with physiotherapy alone in improving gross motor function and reducing spasticity in children with spastic diplegia.
Read the detailed description
PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by age and the ability to ambulate 50 feet unaided. Each stratum is block randomized.
Patients are randomly assigned to surgery plus intensive physical therapy versus intensive physical therapy alone.
The surgical procedure is a selective dorsal rhizotomy. Physical therapy (PT) includes passive and active range of motion, facilitation of isolated muscle control, transitional movements, strengthening, transfer skills, and gait training. The PT schedule is 2-hour sessions 5 days a week for 1 month, 1-hour sessions 5 days a week for 5 months, then a standard therapy program for the remainder of the study (total of 6 months). Parents supervise exercise on non-PT days.
Patients are followed at 6, 12, and 24 months.
- Conditions
- Spastic Diplegia
- Being tested
- Surgery, Physical therapy
- Keywords
- cerebral palsy, neurologic and psychiatric disorders, rare disease, spastic diplegia
- Medical subject headings
- Cerebral Palsy, Neurologic Manifestations, Mental Disorders, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Physical therapyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2000 (estimated)
- Study startOct 1991
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spastic DiplegiaStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Seattle Children's Hospital
- Investigators
- John F. McLaughlin, Study chair, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004751
- Sponsor's protocol ID
- 199/11667
- Other IDs
- CHS-01699211
- Status last verified
- Feb 1997
- First submitted
- 24 Feb 2000
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized Study of Selective Dorsal Rhizotomy and Physiotherapy Vs Physiotherapy Alone for Spastic Diplegia
- ClinicalTrials.gov ID
- NCT00004751
- Acronym / sponsor ID
- 199/11667
- Conditions
- Spastic Diplegia
- Keywords
- cerebral palsy, neurologic and psychiatric disorders, rare disease, spastic diplegia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Collaborators
- Seattle Children's Hospital
- Study start
- Oct 1991
- First posted
- 25 Feb 2000 (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.
OBJECTIVES:
- Assess the efficacy and safety of selective dorsal rhizotomy and physiotherapy compared with physiotherapy alone in improving gross motor function and reducing spasticity in children with spastic diplegia.
Detailed description
PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by age and the ability to ambulate 50 feet unaided. Each stratum is block randomized.
Patients are randomly assigned to surgery plus intensive physical therapy versus intensive physical therapy alone.
The surgical procedure is a selective dorsal rhizotomy. Physical therapy (PT) includes passive and active range of motion, facilitation of isolated muscle control, transitional movements, strengthening, transfer skills, and gait training. The PT schedule is 2-hour sessions 5 days a week for 1 month, 1-hour sessions 5 days a week for 5 months, then a standard therapy program for the remainder of the study (total of 6 months). Parents supervise exercise on non-PT days.
Patients are followed at 6, 12, and 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| Surgery | Procedure or surgery | – |
| Physical therapy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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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.
John F. McLaughlin study chair
Seattle Children's Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Surgery and Physical therapy in people with Spastic Diplegia, run by National Institute of Neurological Disorders and Stroke (NINDS).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
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 24 Jun 2005.