NCT07669857

Brief Summary

The goal of this clinical trial is to evaluate the effect of plyometric training with cross-education on lower limb muscle strength, selective motor control, and balance in children with hemiplegic cerebral palsy (HCP). It will also assess the safety and feasibility of applying this training program in pediatric rehabilitation. The main questions it aims to answer are: Does plyometric training with cross-education improve lower limb muscle strength in children with HCP? Does it improve selective motor control in the affected lower limb? Does it improve balance in children with HCP? Researchers will compare a study group receiving conventional physiotherapy plus plyometric training applied to the less affected limb to a control group receiving conventional physiotherapy only. Participants will: Receive treatment for 12 weeks (2 sessions per week) Attend regular physiotherapy sessions including stretching, strengthening, balance, and gait training Participate in plyometric exercises (study group only) Be assessed before and after the intervention using standardized tests for muscle strength, selective motor control, and balance

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress39%
Jun 2026Sep 2026

First Submitted

Initial submission to the registry

June 21, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 25, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

June 25, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2026

Expected
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

June 25, 2026

Status Verified

June 1, 2026

Enrollment Period

3 months

First QC Date

June 21, 2026

Last Update Submit

June 21, 2026

Conditions

Keywords

Cross-education effectHemiplegic cerebral palsyPlyometric training

Outcome Measures

Primary Outcomes (3)

  • Lower Limb Muscle Strength

    Lower limb muscle strength will be assessed in the more affected limb using a hand-held dynamometer (HHD). Quadriceps and hamstring muscle groups will be tested. The "make test" will be used to measure maximal isometric muscle strength. Each child will be instructed to gradually generate maximal force over approximately 5 seconds while maintaining a fixed joint position to avoid compensatory movements. The dynamometer will be stabilized and resistance applied via an ankle cuff positioned above the malleoli. Each muscle group will be tested three times, with 30 seconds rest between trials. The average of the three maximal voluntary contractions will be recorded as the final value. Standardized positioning and verbal encouragement will be used to ensure maximal effort

    12 weeks

  • Selective Motor Control (SMC)

    Selective motor control of the lower limb will be assessed using the Selective Control Assessment of the Lower Extremity (SCALE), which is a simple clinical tool that can be completed in less than 15 minutes and does not require special equipment (Fowler et al., 2009). The SCALE will be used to evaluate selective voluntary motor control at five joints of the lower limb including the hip, knee, ankle, subtalar joint, and toes on both sides. For each joint, a representative movement that is independent of typical synergistic flexor or extensor patterns will be selected. Most assessments will be performed in sitting position, while hip movements will be assessed in side-lying position to allow optimal observation of movement control. These standardized positions also facilitate visual feedback and accommodate potential proprioceptive deficits. The examiner will demonstrate each movement before testing. Children will then be asked to perform the movement independently, and performance wil

    12 weeks

  • Balance

    Postural stability will be assessed using the Biodex Balance System (BBS), a computerized dynamic platform used to evaluate neuromuscular control and balance performance. The system allows controlled platform movement in anterior-posterior and medial-lateral directions and provides stability indices including the Overall Stability Index (OSI), Anteroposterior Stability Index (APSI), and Mediolateral Stability Index (MLSI), which reflect postural control abilities Prior to testing, each child will undergo a familiarization session to ensure understanding of the procedure and reduce anxiety. During assessment, the child will stand barefoot on the platform in a two-leg stance with arms at the sides. Safety handrails will be adjusted according to height, but children will be instructed not to hold them during testing.

    12 weeks

Study Arms (2)

Study Group

EXPERIMENTAL
Other: Conventional PhysiotherapyOther: Plyometric training

Control group

ACTIVE COMPARATOR
Other: Conventional Physiotherapy

Interventions

Stretching, strengthening, balance, and gait training program.

Control groupStudy Group

The plyometric training program will be applied to the less affected lower limb and is designed to enhance neuromuscular performance, explosive strength, proprioception, and motor coordination through rapid eccentric-concentric muscle actions. Each training session will begin with a 5-minute warm-up to prepare the child physically and psychologically for exercise. The main training phase will include progressive plyometric exercises targeting lower limb function. A 5-minute cool-down period will be performed at the end of each session to promote muscle relaxation and reduce fatigue

Study Group

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosed with HCP by a pediatric neurologist.
  • Age range 6 and 10 years old.
  • Their grade of spasticity level 1 or 1+ according to MAS.
  • Their gross motor function level is I, II on GMFCS.
  • Able to follow verbal instructions and cooperate during assessment and training.

You may not qualify if:

  • Presence of corrective neurological/musculoskeletal surgery of the lower limb in the previous year or botulinum toxin injections of the lower limb within the previous 6 months.
  • Presence of visual or auditory impairments that would affect balance performance.
  • Uncontrolled epileptic seizures or recent medication changes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Cairo University

Giza, Giza Governorate, 11562, Egypt

Location

Faculty of physical therapy Cairo University

Cairo, Egypt

Location

Physical therapy Cairo University

Giza, Egypt

Location

MeSH Terms

Interventions

Plyometric Exercise

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Mayada Ghalwash Abdelkarem

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned into two parallel groups: a study group receiving conventional physiotherapy combined with unilateral plyometric training applied to the less affected lower limb, and a control group receiving conventional physiotherapy only
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 21, 2026

First Posted

June 25, 2026

Study Start

June 25, 2026

Primary Completion (Estimated)

September 25, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

June 25, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations