Unilateral Versus Bilateral Lower-Limb Plyometric Training in Children With Cerebral Palsy
Primary Purpose
Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Unilateral plyometric training
Bilateral plyometric training
Standard physical therapy
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy
Eligibility Criteria
Inclusion Criteria:
- Unilateral cerebral palsy
- Age 12-18 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/contractures
- Musculoskeletal or neural surgery in the last year
- BOTOX injection in the last 6 months.
- Cardiopulmonary disorders that interfere with the ability to engage in exercise training.
- Perceptual and/or behavioral disorders.
Sites / Locations
- Ragab K. Elnaggar
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Paretic-limb-only plyometric training group
Doule-limb plyometric training
Control group
Arm Description
Participants in this group performed plyometric movements/exercises unilaterally using the paretic leg.
Participants in this group performed plyometric movements/exercises bilaterally through the paretic and non-paretic legs.
Participants in this group received the standard physical rehabilitation program.
Outcomes
Primary Outcome Measures
Spatial gait symmetry
The spatial gait symmetry index was measured about the step length of the paretic and non-paretic leg through the portable GAITRite system. Lower scores indicate a more symmetrical pattern.
Temporal gait symmetry
The temporal gait symmetry index was measured about the single-limb support time of the paretic and non-paretic leg through the portable GAITRite system. Lower scores indicate a more symmetrical pattern
Limit of postural stability
The capacity to control and move the center-of-gravity in various directions across their base-of-support was assessed utilizing the Biodex balance system. Values are expressed as accuracy % and higher scores mean better balance capability.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05302102
Brief Title
Unilateral Versus Bilateral Lower-Limb Plyometric Training in Children With Cerebral Palsy
Official Title
Paretic-limb-only Plyometric Training Versus Volume-matched Double-limb Training for Ameliorating Balance Capability and Gait Symmetry in Adolescents With Unilateral Cerebral Palsy: A Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 6, 2019 (Actual)
Primary Completion Date
August 27, 2020 (Actual)
Study Completion Date
August 27, 2020 (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
No
5. Study Description
Brief Summary
This study was set out to compare the effect of paretic-limb-only plyometric training versus double-limb training on balance capability and gait symmetry in adolescents with unilateral cerebral palsy (U-CP). Sixty-nine children with U-CP were randomly allocated to the paretic-limb-only plyometric training group (n = 23; performed plyometric movements/exercises unilaterally using the paretic leg only), the double-limb plyometric training group (n = 23; performed plyometric movements/exercises bilaterally through both lower legs), or the Control group (n =23, received standard rehabilitation plus SSC exercises). All groups were assessed for gait-symmetry and balance capability pre and post-treatment.
Detailed Description
Sixty-nine children with U-CP were recruited from the Physical Therapy Outpatient Clinic of College 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 12 and 18 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, had attentional neglect, and if they had cardiopulmonary problems preventing them from performing high-intense exercise training.
Outcome measures
Gait-symmetry Indices: Gait symmetry indices (Spatial and temporal) were measured through the portable GAITRite system.
Dynamic balance: The directional dynamic limit of stability (forward, backward, paretic, and non-paretic) and overall limit of stability were assessed using the Biodex balance system.
All groups were trained for 45 minutes, twice per week, for 12 successive weeks. The paretic-limb-only plyometric training group performed plyometric movements/exercises unilaterally using the paretic leg only. The double-limb plyometric training group performed plyometric movements/exercises bilaterally through both lower legs. The plyometric training program consisted of five unilateral and five bilateral lower limb plyometrics in the form of hopping/bounding/jumping activities. The plyometric training was preceded by a warm-up for 5 minutes and ended up with a 5-min cooldown. The control group received the standard rehabilitation program, which comprised advanced balance training, and gait training exercises, postural and flexibility exercises, strength training exercises.
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, randomized controlled clinical trial
Masking
Outcomes Assessor
Masking Description
This was a single-blind protocol. The researcher who collected the data was blinded to the treatment allocation.
Allocation
Randomized
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Paretic-limb-only plyometric training group
Arm Type
Experimental
Arm Description
Participants in this group performed plyometric movements/exercises unilaterally using the paretic leg.
Arm Title
Doule-limb plyometric training
Arm Type
Experimental
Arm Description
Participants in this group performed plyometric movements/exercises bilaterally through the paretic and non-paretic legs.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Participants in this group received the standard physical rehabilitation program.
Intervention Type
Other
Intervention Name(s)
Unilateral plyometric training
Intervention Description
The paretic-limb-only plyometric training group received a plyometric exercise program performed unilaterally through the paretic leg only for 45 minutes, three times per week for 12 successive weeks. The training was conducted under close supervision of a licensed pediatric physical therapist according to safety performance guidelines defined by the American Academy of Pediatrics and the US National Strength and Conditioning Association.
Intervention Type
Other
Intervention Name(s)
Bilateral plyometric training
Intervention Description
The double-limb plyometric training group received a plyometric exercise program performed bilaterally through the paretic and non-paretic legs for 45 minutes, three times per week for 12 successive weeks. The training was conducted under close supervision of a licensed pediatric physical therapist according to safety performance guidelines defined by the American Academy of Pediatrics and the US National Strength and Conditioning Association.
Intervention Type
Other
Intervention Name(s)
Standard physical therapy
Intervention Description
The control group received the standard physical rehabilitation program conducted for 45 minutes, thrice a week for 12 consecutive weeks, and consisted of advanced balance training, gait training, postural and flexibility exercises, and strength training exercises.
Primary Outcome Measure Information:
Title
Spatial gait symmetry
Description
The spatial gait symmetry index was measured about the step length of the paretic and non-paretic leg through the portable GAITRite system. Lower scores indicate a more symmetrical pattern.
Time Frame
2 months
Title
Temporal gait symmetry
Description
The temporal gait symmetry index was measured about the single-limb support time of the paretic and non-paretic leg through the portable GAITRite system. Lower scores indicate a more symmetrical pattern
Time Frame
2 months
Title
Limit of postural stability
Description
The capacity to control and move the center-of-gravity in various directions across their base-of-support was assessed utilizing the Biodex balance system. Values are expressed as accuracy % and higher scores mean better balance capability.
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Unilateral cerebral palsy
Age 12-18 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/contractures
Musculoskeletal or neural surgery in the last year
BOTOX injection in the last 6 months.
Cardiopulmonary disorders that interfere with the ability to engage in exercise training.
Perceptual and/or behavioral disorders.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ragab K Elnaggar, PhD
Organizational Affiliation
Prince Sattam Bin Abdulaziz University
Official's Role
Principal Investigator
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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Unilateral Versus Bilateral Lower-Limb Plyometric Training in Children With Cerebral Palsy
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