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

NCT05301738 | Completed DMC

• 1 other identifier: RHPT/0020/0059
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (13)

• 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.

  2 months

• 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.

  2 months

• 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.

  2 months

• Fascicle length

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

  2 months

• Pennation angle

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

  2 months

• Gastrocnemius muscle thickness

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

  2 months

• 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.

  2 months

• 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.

  2 months

• 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.

  2 months

• 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.

  2 months

• Achilles tendon strain

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

  2 months

• Achilles tendon stress

  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

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

  2 months

Study Arms (2)

Plyometric exercise group

EXPERIMENTAL

Participants in this group received the plyometric training program

Other: Plyometric Exercises

Control group

ACTIVE COMPARATOR

Participants in this group received the standard physical rehabilitation program

Other: Standard Physical Therapy

Interventions

Plyometric Exercises OTHER

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

Plyometric exercise group

Standard Physical Therapy OTHER

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.

Control group

Eligibility Criteria

• Age: 10 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Ragab K. Elnaggar

Al Kharj, Riyadh Region, Saudi Arabia

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Plyometric Exercise

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ragab K Elnaggar, PhD

  Prince Sattam Bin Abdulaziz University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This was a single-blind protocol. The researcher who collected the data was blind to the allocation of treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: A prospective pre-test post-test randomized controlled trial

Study Record Dates

• First Submitted: March 20, 2022
• First Posted: March 31, 2022
• Study Start: November 1, 2020
• Primary Completion: December 2, 2021
• Study Completion: December 2, 2021
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)