Plyometric Exercise-induced Mechano-morphological Changes of Plantar Flexor Muscle-tendon Unit in Cerebral Palsy

March 20, 2022 updated by: Ragab Kamal Elnaggar, Cairo University

Plyometric Exercise-induced Mechanical and Morphological Changes in Plantar Flexors' Muscle-tendon Unit in Children With Unilateral Cerebral Palsy: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

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

  1. 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.
  2. 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

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Riyadh
      • Al Kharj, Riyadh, Saudi Arabia
        • Ragab K. Elnaggar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 16 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2020

Primary Completion (ACTUAL)

December 2, 2021

Study Completion (ACTUAL)

December 2, 2021

Study Registration Dates

First Submitted

March 20, 2022

First Submitted That Met QC Criteria

March 20, 2022

First Posted (ACTUAL)

March 31, 2022

Study Record Updates

Last Update Posted (ACTUAL)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 20, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • RHPT/0020/0059

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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