Plyometric Exercise-induced Mechano-morphological Changes of Plantar Flexor Muscle-tendon Unit in Cerebral Palsy
Primary Purpose
Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Plyometric Exercises
Standard Physical Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy
Eligibility Criteria
Inclusion Criteria:
- Hemiparetic cerebral palsy
- Age between 10 to 16 years
- Spasticity level 1 or 1+ according to the Modified Ashworth Scale
- Gross motor function level I or II according to the Gross Motor Function Classification System
Exclusion Criteria:
- Structural deformities
- Musculoskeletal or neural surgery in the last year
- BOTOX injection in the last 6 months.
- Cardiopulmonary disorders limit the ability to engage in explosive exercise training
- Perceptual and behavioral disorders.
Sites / Locations
- Ragab K. Elnaggar
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Plyometric exercise group
Control group
Arm Description
Participants in this group received the plyometric training program
Participants in this group received the standard physical rehabilitation program
Outcomes
Primary Outcome Measures
Gastrocnemius muscle-tendon length
The distance from the medial femoral epicondyle to the insertion of the Achilles tendon on the calcaneus. The gastrocnemius muscle-tendon length normalized to the lower limb length (%) was recorded.
Achilles tendon length
The distance from the gastrocnemius muscle-tendon junction to its insertion. The achilles tendon length normalized to the lower limb length (%) was recorded.
Gastrocnemius muscle belly length
Distance between the medial femoral epicondyle and its muscle-tendon junction. The gastrocnemius muscle belly length normalized to the lower limb length (%) was recorded.
Fascicle length
The linear distance (mm) between the insertion into the deep and superficial aponeurosis.
Pennation angle
The angle (in degrees) between the fascicle and the deep aponeurosis.
Gastrocnemius muscle thickness
The perpendicular distance (mm) between the deep and superficial aponeurosis.
Passive range of motion of the ankle
The passive ankle dorsi and plantar flexion angle (degrees) were measured by moving the ankle into maximum dorsiflexion and plantarflexion through the isokinetic dynamometry.
Isometric maximum voluntary contractions of the plantar flexors.
The isometric maximum voluntary contraction was determined as the maximum rate of force (Nm) that participants were able to develop during an isometric contraction of the plantar flexors with the ankle in a neutral position (90 degrees) and the knee in a full extension.
Achilles tendon elongation
The difference (mm) between the calculated length changes of the muscle-tendon unit and the muscle-length changes recorded by the ultrasound.
Achilles tendon stiffness
The achilles tendon stiffness (N/m) was calculated through linear regression of the absolute tendon force and related changes in tendon length.
Achilles tendon strain
The achilles tendon strain (%) was calculated as the tendon elongation divided by the initial tendon length
Achilles tendon stress
The achilles tendon stress was calculated as the tendon elongation divided by the initial tendon length and expressed in (N/mm2).
Young's modulus
Young's modulus (N/mm2) was calculated as the ratio of achilles tendon tensile stress to tensile strain
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05301738
Brief Title
Plyometric Exercise-induced Mechano-morphological Changes of Plantar Flexor Muscle-tendon Unit in Cerebral Palsy
Official Title
Plyometric Exercise-induced Mechanical and Morphological Changes in Plantar Flexors' Muscle-tendon Unit in Children With Unilateral Cerebral Palsy: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
December 2, 2021 (Actual)
Study Completion Date
December 2, 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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study was designed to investigate the effect of three months of plyometric exercise training on the mechanical and morphological properties of the plantar flexor muscle-tendon unit in children with unilateral cerebral palsy (UCP). Thirty-eight children with UCP were randomly allocated to the plyometric exercise group (n = 19, underwent a plyometric training program) or the Control group (n =19, received usual physical rehabilitation alone). Both groups were assessed for the plantar flexors' morphological and mechanical properties before and after treatment.
Detailed Description
Thirty-eight children with CP participated in the study. They were recruited from King Khalid Hospital and Physical Therapy Center of College of Applied Medical Sciences at Prince Sattam bin Abdulaziz University, Al-Kharj, Saudi Arabia. Their age ranged between 10 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 nonreducible structural deformities, received neurolytic agents such as BOTOX or Phenol injections in the past six months, underwent neuromuscular or orthopedic surgery in the last 12 months, or if they had cardiopulmonary problems preventing them from performing high-intense exercise training.
Outcome measures
Plantar Flexors' Morphological Properties: length of gastrocnemius muscle-tendon unit, gastrocnemius muscle belly, and achilles, in addition to fascicle length, pennation angle, and gastrocnemius muscle thickness were assessed using a standard high-resolution ultrasound imaging system.
Plantar Flexors' Mechanical Properties: Passive range of motion of the ankle joint and maximum isometric voluntary contraction were assessed using an isokinetic dynamometer.
The plyometric exercise group received a 12-week plyometric training program. Each session lasted 45 minutes and was repeated two times a week. The training was conducted in conformity with the National Strength and Conditioning Association guidelines and American Academy of Pediatrics safety standards. The plyometric exercise program consisted of ten unilateral and bilateral lower limb plyometrics in the form of hopping/bounding/jumping activities. The Iplyometric workout was proceeded by a 5-minute warm-up and ended up with a 5-minute cool-down. The control group received their usual physical rehabilitation program for 45 minutes, twice/week for 12 consecutive weeks. The program 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 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
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Plyometric exercise group
Arm Type
Experimental
Arm Description
Participants in this group received the plyometric training program
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)
Plyometric Exercises
Intervention Description
The plyometric exercise group received a 12-week plyometric training program. Each session lasted 45 minutes and was repeated two times a week. The training was conducted in conformity with the National Strength and Conditioning Association guidelines and American Academy of Pediatrics safety standards. The plyometric exercise program consisted of ten unilateral and bilateral lower limb plyometrics in the form of hopping/bounding/jumping activities. The Iplyometric workout was proceeded by a 5-minute warm-up and ended up with a 5-minute cool-down
Intervention Type
Other
Intervention Name(s)
Standard Physical Therapy
Intervention Description
The control group received their usual physical rehabilitation program for 45 minutes, twice/week for 12 consecutive weeks. The program comprised advanced balance training, and gait training exercises, postural and flexibility exercises, strength training exercises.
Primary Outcome Measure Information:
Title
Gastrocnemius muscle-tendon length
Description
The distance from the medial femoral epicondyle to the insertion of the Achilles tendon on the calcaneus. The gastrocnemius muscle-tendon length normalized to the lower limb length (%) was recorded.
Time Frame
2 months
Title
Achilles tendon length
Description
The distance from the gastrocnemius muscle-tendon junction to its insertion. The achilles tendon length normalized to the lower limb length (%) was recorded.
Time Frame
2 months
Title
Gastrocnemius muscle belly length
Description
Distance between the medial femoral epicondyle and its muscle-tendon junction. The gastrocnemius muscle belly length normalized to the lower limb length (%) was recorded.
Time Frame
2 months
Title
Fascicle length
Description
The linear distance (mm) between the insertion into the deep and superficial aponeurosis.
Time Frame
2 months
Title
Pennation angle
Description
The angle (in degrees) between the fascicle and the deep aponeurosis.
Time Frame
2 months
Title
Gastrocnemius muscle thickness
Description
The perpendicular distance (mm) between the deep and superficial aponeurosis.
Time Frame
2 months
Title
Passive range of motion of the ankle
Description
The passive ankle dorsi and plantar flexion angle (degrees) were measured by moving the ankle into maximum dorsiflexion and plantarflexion through the isokinetic dynamometry.
Time Frame
2 months
Title
Isometric maximum voluntary contractions of the plantar flexors.
Description
The isometric maximum voluntary contraction was determined as the maximum rate of force (Nm) that participants were able to develop during an isometric contraction of the plantar flexors with the ankle in a neutral position (90 degrees) and the knee in a full extension.
Time Frame
2 months
Title
Achilles tendon elongation
Description
The difference (mm) between the calculated length changes of the muscle-tendon unit and the muscle-length changes recorded by the ultrasound.
Time Frame
2 months
Title
Achilles tendon stiffness
Description
The achilles tendon stiffness (N/m) was calculated through linear regression of the absolute tendon force and related changes in tendon length.
Time Frame
2 months
Title
Achilles tendon strain
Description
The achilles tendon strain (%) was calculated as the tendon elongation divided by the initial tendon length
Time Frame
2 months
Title
Achilles tendon stress
Description
The achilles tendon stress was calculated as the tendon elongation divided by the initial tendon length and expressed in (N/mm2).
Time Frame
2 months
Title
Young's modulus
Description
Young's modulus (N/mm2) was calculated as the ratio of achilles tendon tensile stress to tensile strain
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hemiparetic cerebral palsy
Age between 10 to 16 years
Spasticity level 1 or 1+ according to the Modified Ashworth Scale
Gross motor function level I or II according to the Gross Motor Function Classification System
Exclusion Criteria:
Structural deformities
Musculoskeletal or neural surgery in the last year
BOTOX injection in the last 6 months.
Cardiopulmonary disorders limit the ability to engage in explosive exercise training
Perceptual and 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
Learn more about this trial
Plyometric Exercise-induced Mechano-morphological Changes of Plantar Flexor Muscle-tendon Unit in Cerebral Palsy
We'll reach out to this number within 24 hrs