CClinicalTrials.gg
CompletedNCT05301738Updated Mar 31, 2022

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

An interventional study of Plyometric Exercises and Standard Physical Therapy in Cerebral Palsy, sponsored by Cairo University. Completed at 1 site in Saudi Arabia. Open to participants aged 10 Years to 16 Years. Per ClinicalTrials.gov, last updated 2022-03-31.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled Nov 2020, registered Mar 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
10 Years to 16 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cerebral Palsy

Browse trials for

03

In context

Cerebral Palsy

1,853 studies on the registry are indexed under Cerebral Palsy; 435 are open to participants now.

This study's enrollment of 38 is above the median of 33 across 1,368 interventional studies indexed under Cerebral Palsy.

Browse Cerebral Palsy studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
38 participants (actual)

Study arms

  • Experimental
    Plyometric exercise group

    Participants in this group received the plyometric training program

    Other: Plyometric Exercises

  • Active comparator
    Control group

    Participants in this group received the standard physical rehabilitation program

    Other: Standard Physical Therapy

Interventions

  • OtherPlyometric Exercises

    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

  • OtherStandard Physical Therapy

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 months

  2. 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.

    Time frame: 2 months

  3. 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.

    Time frame: 2 months

  4. Fascicle length

    The linear distance (mm) between the insertion into the deep and superficial aponeurosis.

    Time frame: 2 months

  5. Pennation angle

    The angle (in degrees) between the fascicle and the deep aponeurosis.

    Time frame: 2 months

  6. Gastrocnemius muscle thickness

    The perpendicular distance (mm) between the deep and superficial aponeurosis.

    Time frame: 2 months

  7. 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.

    Time frame: 2 months

  8. 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.

    Time frame: 2 months

  9. 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.

    Time frame: 2 months

  10. 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.

    Time frame: 2 months

  11. Achilles tendon strain

    The achilles tendon strain (%) was calculated as the tendon elongation divided by the initial tendon length

    Time frame: 2 months

  12. Achilles tendon stress

    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

  13. Young's modulus

    Young's modulus (N/mm2) was calculated as the ratio of achilles tendon tensile stress to tensile strain

    Time frame: 2 months

07

Study locations

1 site
  • Ragab K. Elnaggar
    Al Kharj, Riyadh, Saudi Arabia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05301738
Lead sponsor
Cairo University
Responsible party
Ragab Kamal Elnaggar (Associate Professor, Cairo University) — Principal investigator
First posted
Mar 31, 2022
Start date
Nov 1, 2020
Primary completion
Dec 2, 2021
Completion
Dec 2, 2021
Last update
Mar 31, 2022

Study contacts

Ragab K Elnaggar, PhD
principal investigator · Prince Sattam Bin Abdulaziz University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion