Isokinetic Strength Training in Children With Hemiparetic 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:
- Hemiparetic cerebral palsy
- Age 8-16 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
Experimental
Active Comparator
Arm Label
IsoK-ST group
Control group
Arm Description
Participants in this group received the usual physical rehabilitation program in addition to an IsoK-ST program.
Participants in this group received the usual physical rehabilitation program only.
Outcomes
Primary Outcome Measures
Weight-bearing symmetry
The weight-bearing symmetry indices of the rearfoot and forefoot segments were measured using a Pressure analysis system.
Gait-symmetry indices
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 the portable GAIT Rite system
Dynamic balance
The directional (forward, backward, paretic, and non-paretic) and overall dynamic limits of stability were assessed through the Biodex balance system.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04907448
Brief Title
Isokinetic Strength Training in Children With Hemiparetic Cerebral Palsy
Official Title
Optimization of Weight-bearing- and Walking-symmetry and Dynamic Balance Using an Isokinetic Strength Training Protocol in Children With Hemiparetic Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
December 23, 2018 (Actual)
Primary Completion Date
January 9, 2020 (Actual)
Study Completion Date
January 9, 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 endeavored to assess the effect of an isokinetic strength training (IsoK-ST) program on weight-bearing symmetry, gait-symmetry, and dynamic balance in children with hemiparetic cerebral palsy (HCP). Thirty-six children with HCP were randomly allocated to the IsoK-ST group (n = 18, received their usual physical rehabilitation program plus an IsoK-ST program) or the Control group (n =18, received usual physical rehabilitation alone). Both groups were assessed for weight-bearing symmetry, gait-symmetry, and dynamic balance before and after treatment.
Detailed Description
Thirty-six children with HCP 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 16 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 structural nonreducible deformities, underwent neuromuscular or orthopedic surgery in the last 12 months, submitted to BOTOX injection in the past 6 months, sensory-perceptual disorders, unstable convulsions, cardiopulmonary problems preventing them from performing high-intense exercise training.
Outcome measures
Weight-bearing symmetry index: The weight-bearing symmetry index for the rearfoot and forefoot segments were assessed through a pressure analysis system
Gait-symmetry Indices: Gait symmetry indices (Spatial and temporal) were measured through the portable GAIT Rite 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.
The IsoK-ST and control groups received their usual physical rehabilitation program for 45 minutes, three times 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 IsoK-ST group received an IsoK-ST program, thrice/week for eight weeks per the National Strength and Conditioning Association guidelines and American Academy of Pediatrics safety standards. The IsoK-ST consisted of 3 sets (5-10 repetitions) of maximal concentric contraction of knee extensors and flexors on the affected side at angular speeds of 90, 120, 180, and 240 deg./sec., with intervals of rest for two minutes after each selected speed. The IsoK-ST workout was proceeded by a 5-minute warm-up and ended up with a 5-minute cool-dowm.
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
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IsoK-ST group
Arm Type
Experimental
Arm Description
Participants in this group received the usual physical rehabilitation program in addition to an IsoK-ST program.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Participants in this group received the usual physical rehabilitation program only.
Intervention Type
Other
Intervention Name(s)
Physical Therapy
Intervention Description
The IsoK-ST group received their usual physical therapy program for 45 minutes, three times a week for eight successive weeks, which comprised advanced balance training, weight-bearing exercises, gait training, postural and flexibility exercises, and strength training exercises.
Additionally, the IsoK-ST group received an IsoK-ST program, thrice/week for eight successive weeks.
The control group received the usual physical rehabilitation program only for 45 minutes, three times a week for eight successive weeks.
Primary Outcome Measure Information:
Title
Weight-bearing symmetry
Description
The weight-bearing symmetry indices of the rearfoot and forefoot segments were measured using a Pressure analysis system.
Time Frame
2 months
Title
Gait-symmetry indices
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 the portable GAIT Rite system
Time Frame
2 months
Title
Dynamic balance
Description
The directional (forward, backward, paretic, and non-paretic) and overall dynamic limits of stability were assessed through the Biodex balance system.
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hemiparetic cerebral palsy
Age 8-16 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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Isokinetic Strength Training in Children With Hemiparetic Cerebral Palsy
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