Back to resultsGait Rehabilitation in Diplegic Children
Primary Purpose
Cerebral Palsy, Spastic Diplegia
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
gait training
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring gait, diplegia, ankle weight, botox injection
Eligibility Criteria
Inclusion Criteria:
- diagnosed as spastic diplegia.
- They were able to follow simple verbal instructions.
- The use of Ankle Foot Orthoses.
- Spasticity grade of 1+ or 2 in both calf and hamstring muscles according to modified Ashworth's scale (MAS).
- level I or II on the Gross Motor Function Classification System (GMFCS).
Exclusion Criteria:
- fixed contractures or deformities in the lower limbs.
- surgical orthopedic intervention.
- Botulinum A injection or use of neuromuscular blockers in the previous 6 months before the start of study.
Sites / Locations
- Faculty of Physical Therapy,Cairo University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Experimental
Arm Label
classical gait training
classical gait training using ankle weight
gait training using ankle weight after botulinum toxin injection
Arm Description
physical therapy exercises including classical gait training
physical therapy exercises including classical gait training while using ankle weight
physical therapy exercises including classical gait training while using ankle weight and with BOTOX injection
Outcomes
Primary Outcome Measures
measurement of knee excursion during gait
evaluation of knee flexion range of motion during gait using two dimension gait analysis.
evaluation of spasticity: modified ashowrth scale scores
hamstring and calf muscles evaluation of spasticity through passive movement .the score ranged from 0 ( nearly normal) to 5 (rigid in flexion or extension)
Secondary Outcome Measures
electromyography to asses spasticity in hamstring and calf muscles
Hoffman/Myogenic reflex to assess spasticity ratio
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05294874
Brief Title
Gait Rehabilitation in Diplegic Children
Official Title
Gait Rehabilitation in Ambulant Diplegic Children Using BOTOX and Ankle Weights
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
July 15, 2021 (Actual)
Primary Completion Date
November 14, 2021 (Actual)
Study Completion Date
November 25, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Background: Standing and walking serve an individual's basic need to move from place to place, and both are the most common activities that people do on a daily basis.
Aim: to investigate the combined effect of botulinum toxin A (BoNT-A) injection and ankle weight on the gait of diplegic children who are using Ankle foot orthoses.
Detailed Description
Methods: Sixty children with spastic diplegia were included in this prospective, controlled trial. Children were divided into three groups, each with 20 patients: Group 1 received classical gait rehabilitation; Group 2 received the same gait training while adding ankle weight ; and Group 3 received the same as group 2 plus botulinum toxin injection. The Modified Ashworth Scale (MAS),knee range-of-motion measures, and Hoffman /Myogenic reflex ratio were used to examine patients before the commencement of treatment and post-treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Spastic Diplegia
Keywords
gait, diplegia, ankle weight, botox injection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
classical gait training
Arm Type
Active Comparator
Arm Description
physical therapy exercises including classical gait training
Arm Title
classical gait training using ankle weight
Arm Type
Active Comparator
Arm Description
physical therapy exercises including classical gait training while using ankle weight
Arm Title
gait training using ankle weight after botulinum toxin injection
Arm Type
Experimental
Arm Description
physical therapy exercises including classical gait training while using ankle weight and with BOTOX injection
Intervention Type
Other
Intervention Name(s)
gait training
Other Intervention Name(s)
rehabilitation
Intervention Description
walking forward, sideway and backward walking on balance board
Primary Outcome Measure Information:
Title
measurement of knee excursion during gait
Description
evaluation of knee flexion range of motion during gait using two dimension gait analysis.
Time Frame
after 3 months of the treatment program.
Title
evaluation of spasticity: modified ashowrth scale scores
Description
hamstring and calf muscles evaluation of spasticity through passive movement .the score ranged from 0 ( nearly normal) to 5 (rigid in flexion or extension)
Time Frame
after 3 months of the treatment program.
Secondary Outcome Measure Information:
Title
electromyography to asses spasticity in hamstring and calf muscles
Description
Hoffman/Myogenic reflex to assess spasticity ratio
Time Frame
after 3 months of the treatment program.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosed as spastic diplegia.
They were able to follow simple verbal instructions.
The use of Ankle Foot Orthoses.
Spasticity grade of 1+ or 2 in both calf and hamstring muscles according to modified Ashworth's scale (MAS).
level I or II on the Gross Motor Function Classification System (GMFCS).
Exclusion Criteria:
fixed contractures or deformities in the lower limbs.
surgical orthopedic intervention.
Botulinum A injection or use of neuromuscular blockers in the previous 6 months before the start of study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nahla mohamed, phd
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Physical Therapy,Cairo University
City
Cairo
State/Province
Giza
ZIP/Postal Code
02
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
tables and figures of statistical analysis published
IPD Sharing Time Frame
after publication of the results
IPD Sharing Access Criteria
through contact the authors
Learn more about this trial
Gait Rehabilitation in Diplegic Children
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