Strength Training in Children With Cerebral Palsy
Primary Purpose
Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Physical Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy
Eligibility Criteria
Inclusion Criteria:
- Unilateral cerebral palsy
- age from 8 to 12 years
- motor function level I or II according to the Gross Motor Function Classification System
- Spasticity level 1 or 1+ according to the Modified Ashworth Scale
Exclusion Criteria:
- Structural deformities
- Musculoskeletal or neural surgery in the last year
- BOTOX injection in the last 6 months.
- cardiopulmonary disorders interfering with the ability to engage in exercise training
- hemispatial neglect
Sites / Locations
- Ragab K. Elnaggar
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control group
SSC group
Arm Description
Participants in this group received the standard physical rehabilitation program.
Participants in this group received the standard physical rehabilitation program as the control group in addition to the SSC exercise program
Outcomes
Primary Outcome Measures
Gait symmetry
Gait symmetry indices (spatial and temporal) were measured about the step length and single-limb support time of the paretic and non-paretic leg through a 3D motion analysis system
Balance Capabilities
Some aspects of balance capabilities including sensory organization, reactive balance, and rhythmic weight shift were measured through a Pro Balance Master sytem.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04892576
Brief Title
Strength Training in Children With Cerebral Palsy
Official Title
Stretch-shortening Cycle Exercises: an Efficient Training Model for Optimizing Gait-symmetry and Balance Capabilities in Children With Unilateral Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
October 28, 2018 (Actual)
Primary Completion Date
November 6, 2019 (Actual)
Study Completion Date
November 6, 2019 (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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study was set out to assess the effect of stretch-shortening (SSC) exercises on gait-symmetry and balance in children with unilateral cerebral palsy (UCP). Forty-two children with UCP were randomly allocated to the control group (n = 21, received standard physical rehabilitation) or the SSC group (n =21, received standard rehabilitation plus SSC exercises). Both groups were assessed for ait-symmetry and balance pre and post-treatment.
Detailed Description
Forty-two children with UCP were recruited from the Physical Therapy Outpatient Clinic of Collee of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, King Khalid Hospital, and a tertiary referral hospital, Al-Kharj, Saudi Arabia. Their age ranged between 8 and 12 years, were functioning at levels I or II according to the Gross Motor Function Classification System, and had spasticity level 1 or 1+ per the Modified Ashworth Scale. Children were excluded if they had fixed deformities, underwent neuromuscular or orthopedic surgery in the last 12 months, submitted to BOTOX injection in the past 6 months, attentional neglect, cardiopulmonary problems preventing them from performing high-intense exercise training.
Outcome measures
Gait-symmetry Indices: Gait symmetry indices (Spatial and temporal) were measured through a 3D motion analysis system.
Balance capabilities: several aspects of balance including sensory organization, reactive balance, and rhythmic weight shift were tested through a Pro Balance Master system.
The control and SSC groups received a standard rehabilitation program for 45 minutes, twice a week for eight consecutive weeks. The program comprised advanced balance training, and gait training exercises, postural and flexibility exercises, strength training exercises. Additionally, the SSC group received an SSC exercise program for 30 minutes, twice/week for eight weeks per the National Strength and Conditioning Association guidelines and American Academy of Pediatrics safety standards. The SSC program consisted of ten unilateral and bilateral lower limb plyometrics in the form of hopping/bounding/jumping activities. The SSC training was preceded by a warm-up for 5 minutes and ended up with a 5-min cooldown.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A prospective pre-test post-test randomized controlled trial
Masking
Outcomes Assessor
Masking Description
This was a single-blind protocol. The researcher who collected the data was blind to the allocation of treatment
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Participants in this group received the standard physical rehabilitation program.
Arm Title
SSC group
Arm Type
Experimental
Arm Description
Participants in this group received the standard physical rehabilitation program as the control group in addition to the SSC exercise program
Intervention Type
Other
Intervention Name(s)
Physical Therapy
Intervention Description
The control group recieved the standard physical rehabilitation program conducted for 45 minutes, twice a week for eight consecutive weeks, and consisted of advanced balance training, gait training, postural and flexibility exercises, and strength training exercises.
The SSC group received the same program in addition to the SSC exercises for 30 minutes, two times per week for eight successive weeks
Primary Outcome Measure Information:
Title
Gait symmetry
Description
Gait symmetry indices (spatial and temporal) were measured about the step length and single-limb support time of the paretic and non-paretic leg through a 3D motion analysis system
Time Frame
2 months
Title
Balance Capabilities
Description
Some aspects of balance capabilities including sensory organization, reactive balance, and rhythmic weight shift were measured through a Pro Balance Master sytem.
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Unilateral cerebral palsy
age from 8 to 12 years
motor function level I or II according to the Gross Motor Function Classification System
Spasticity level 1 or 1+ according to the Modified Ashworth Scale
Exclusion Criteria:
Structural deformities
Musculoskeletal or neural surgery in the last year
BOTOX injection in the last 6 months.
cardiopulmonary disorders interfering with the ability to engage in exercise training
hemispatial neglect
Facility Information:
Facility Name
Ragab K. Elnaggar
City
Al Kharj
State/Province
Riyadh
Country
Saudi Arabia
12. IPD Sharing Statement
Plan to Share IPD
No
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Strength Training in Children With Cerebral Palsy
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