- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05006144
Effects of Physical Training Following Selective Dorsal Rhizotomy on Non-ambulant Children With Bilateral Spastic Cerebral Palsy
Effects of Physical Training Following Selective Dorsal Rhizotomy on Trunk Control, Selectivity and Upper Extremity Function of Non-ambulant Children With Bilateral Spastic Cerebral Palsy: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
increased tone of lower extremity muscles interfere with the child sitting posture and trunk control. delayed sitting and lack of trunk control contribute to the impairments of upper extremity functions.
selective dorsal rhizotomy is a surgical procedure to control increased tone of the lower extremities. Therefore, the current study is carried out to investigate the effects of selective dorsal rhizotomy on trunk control, selectivity and upper extremity function of non-ambulant children with bilateral spastic cerebral palsy
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Giza, Egypt, 12662
- Amira Mahmoud Abd-elmonem
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- CP, spastic diplegia
- 4-7 years of age
- On Level IV-V on Gross Motor Function Classification System
- Partial trunk control (sitting with support).
Exclusion Criteria:
- Structural non-reducible deformities or musculoskeletal surgery in the lower extremities in the past 12 months
- Ankle clonus
- Exaggerated deep tendon reflex in the legs
- Babinski sign;
- Moderate to severe signs of dystonia, athetosis or ataxia.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: control group
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A custom-made articulating ankle foot orthosis
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Experimental: SDR-group
selective dorsal rhizotomy
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A custom-made articulating ankle foot orthosis
All SDRs were performed by a single neurosurgeon through an osteoplastic laminotomy from L2 to L5
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Segmental trunk control
Time Frame: period of the treatment was 4 successive months
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The Segmental Assessment of Trunk Control is applied to assess upright trunk postural control in sitting position based on subdividing the trunk into 6 segments.
The head/trunk control is acquired segment by segment if upright sitting posture can be maintained under three conditions including: static control at static position, active control while the child moves the head and/or arm and reactive control after external perturbation.The trunk segments according to the scale include: head/neck, thoracic (upper, mid and lower) and lumbar (upper and lower) segments.
It is an ordinal scale with a grade 1 to 7 is assigned for each segment with the score 7 indicates that the infant can't retain independent sitting (no hand support).
A score of 8 is given as full trunk control is gained.
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period of the treatment was 4 successive months
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Gross motor function
Time Frame: period of the treatment was 4 successive months
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The gross motor function measure-88 is a valid and reliable criterion referenced instrument; is currently used to evaluate the motor function over time in individuals with cerebral palsy.
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period of the treatment was 4 successive months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
upper extremity function
Time Frame: period of the treatment was 4 successive months
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The quality of upper extremity skill test is a reliable and valid tool used to measure the motor function in children with cerebral palsy ages of 18 months to 8 years.
T
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period of the treatment was 4 successive months
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Hazem A Aly, Phd, PhD of physical therapy for pediatrics, faculty of physical therapyCairo university
- Study Director: Ahmed rabie, Phd, Department of neurosurgery, faculty of medicine , Alexandria university
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- spastic cerebral palsy
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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