- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05301738
Plyometric Exercise-induced Mechano-morphological Changes of Plantar Flexor Muscle-tendon Unit in Cerebral Palsy
Plyometric Exercise-induced Mechanical and Morphological Changes in Plantar Flexors' Muscle-tendon Unit in Children With Unilateral Cerebral Palsy: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Riyadh
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Al Kharj, Riyadh, Saudi Arabia
- Ragab K. Elnaggar
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Plyometric exercise group
Participants in this group received the plyometric training program
|
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
|
ACTIVE_COMPARATOR: Control group
Participants in this group received the standard physical rehabilitation program
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gastrocnemius muscle-tendon length
Time Frame: 2 months
|
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.
|
2 months
|
Achilles tendon length
Time Frame: 2 months
|
The distance from the gastrocnemius muscle-tendon junction to its insertion.
The achilles tendon length normalized to the lower limb length (%) was recorded.
|
2 months
|
Gastrocnemius muscle belly length
Time Frame: 2 months
|
Distance between the medial femoral epicondyle and its muscle-tendon junction.
The gastrocnemius muscle belly length normalized to the lower limb length (%) was recorded.
|
2 months
|
Fascicle length
Time Frame: 2 months
|
The linear distance (mm) between the insertion into the deep and superficial aponeurosis.
|
2 months
|
Pennation angle
Time Frame: 2 months
|
The angle (in degrees) between the fascicle and the deep aponeurosis.
|
2 months
|
Gastrocnemius muscle thickness
Time Frame: 2 months
|
The perpendicular distance (mm) between the deep and superficial aponeurosis.
|
2 months
|
Passive range of motion of the ankle
Time Frame: 2 months
|
The passive ankle dorsi and plantar flexion angle (degrees) were measured by moving the ankle into maximum dorsiflexion and plantarflexion through the isokinetic dynamometry.
|
2 months
|
Isometric maximum voluntary contractions of the plantar flexors.
Time Frame: 2 months
|
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.
|
2 months
|
Achilles tendon elongation
Time Frame: 2 months
|
The difference (mm) between the calculated length changes of the muscle-tendon unit and the muscle-length changes recorded by the ultrasound.
|
2 months
|
Achilles tendon stiffness
Time Frame: 2 months
|
The achilles tendon stiffness (N/m) was calculated through linear regression of the absolute tendon force and related changes in tendon length.
|
2 months
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Achilles tendon strain
Time Frame: 2 months
|
The achilles tendon strain (%) was calculated as the tendon elongation divided by the initial tendon length
|
2 months
|
Achilles tendon stress
Time Frame: 2 months
|
The achilles tendon stress was calculated as the tendon elongation divided by the initial tendon length and expressed in (N/mm2).
|
2 months
|
Young's modulus
Time Frame: 2 months
|
Young's modulus (N/mm2) was calculated as the ratio of achilles tendon tensile stress to tensile strain
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2 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RHPT/0020/0059
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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