Effect of Task Oriented Training With Functional Electrical Stimulation on Balance in Children With Hemiparesis

To investigate the efficacy of combination of task-oriented training and Functional electrical stimulation of ankle dorsiflexor muscles on:

1. Strength of ankle muscles in children with hemiparesis.
2. Balance in children with hemiparesis.

Study Overview

• Status: Recruiting
• Conditions: Hemiparesis; Children, Only
• Intervention / Treatment: Other: Selected therapeutic program; Other: Selected Task oriented training program; Device: Selected Functional electrical stimulation

Detailed Description

Children with hemiparetic cerebral palsy often favor their non-paretic side, leading to asymmetrical walking and balance issues. Muscle weakness significantly restricts motor function, prompting a shift from spasticity management to strength training, which has a positive correlation with gross motor function and gait. Task-oriented training has been shown to enhance balance. Children with hemiparesis tend to prefer mobility equipment due to balance disturbances. Functional electrical stimulation of ankle dorsiflexors combined with task-oriented training is being investigated for its effectiveness in improving balance in these children.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nourhan Reda Abdel Razek Dawood, physical therapist; Phone Number: 01017173755; Email: Eman_pediatrics2016@yahoo.com

Study Locations

• Egypt
  • Damietta, Egypt
    • Recruiting
    • Damietta general hospital.
    • Contact: Nourhan Reda Abdel Razek Dawood, physical therapist; Phone Number: 01017173755; Email: Eman_pediatrics2016@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. The age of the selected children will be ranged from 6 to 9 years.
2. Able to follow simple instructions.
3. Degree of spasticity is ranging from 1to 1+ according to modified Ashworth scale.
4. The level of motor function of the children will be levels I-II according to Gross Motor Function Classification System.

Exclusion Criteria:

The children will be excluded if they have one or more of the following criteria:

1. Visual, hearing disorders.
2. Recent Botox injection or orthopedic surgery in the lower limb in the last 6 months before the start of the study.
3. Any fixed deformity of lower limb.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: conventional exercise program; The control group consist of 18 children will receive conventional exercise program for 60 min.	Other: Selected therapeutic program; The program will run three days a week on non-consecutive days, focusing on various exercises for children. Activities include: 1) knee manipulation for balance; 2) guided body weight shifting; 3) balancing on a board; 4) training for equilibrium and protective reactions; 5) gait training in a closed environment with obstacles; 6) open environment gait training; 7) strengthening exercises for the back, hips, and knees; and 8) passive stretching for tight muscles in both lower and upper limbs.
Experimental: task-oriented training; Study group consist of 18 children will receive task-oriented training while applying the functional electrical stimulation on the affected lower limb for 20 min in addition to conventional exercise program for 40 min.	Other: Selected therapeutic program; The program will run three days a week on non-consecutive days, focusing on various exercises for children. Activities include: 1) knee manipulation for balance; 2) guided body weight shifting; 3) balancing on a board; 4) training for equilibrium and protective reactions; 5) gait training in a closed environment with obstacles; 6) open environment gait training; 7) strengthening exercises for the back, hips, and knees; and 8) passive stretching for tight muscles in both lower and upper limbs.; Other: Selected Task oriented training program; 1. Activities involve standing and reaching for objects at various distances and heights. 2. Sit-to-stand tasks are performed from different chair heights and while carrying objects. 3. Stepping activities occur in various directions and on different block heights and surfaces. 4. Alternating heel and toe raises focus on increasing repetitions. 5. Stairs are ascended and descended with added weight and object carrying. 6. Backward walking starts near a wall, progressing to shuttle runs. 7. Walking on a balance beam involves increased speed and varied surfaces.; Device: Selected Functional electrical stimulation; The study will utilize Everyway Medical Instruments for electrical stimulation, with one electrode on the tibialis anterior muscle and the other on the common peroneal nerve. A tilt sensor will trigger stimulation during the swing phase of the tibia. The stimulation parameters include a pulse frequency of 25-40 hertz, a pulse duration of 250 to 300 milliseconds, and an on-off time ratio of 1:2 for 20 minutes, aimed at inducing ankle dorsiflexion while preventing inversion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of balance	Pediatric balance scale will be used to assess balance for all children participated in this study. It contains 14-item. Scoring for each item is scored 0 points (lowest function) to 4 points (highest function), with maximum score of 56 points. Calculation of the total score by summation of the score of the 14 items	at baseline and after 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of muscle strength	Each child will practice two trials per test to ensure familiarity. Peak force values will be recorded using the handheld dynamometer after three trials for both break and method tests for each muscle group. Standardized instructions will be provided, and encouragement will be given for maximal effort. During the break test, force will increase progressively over one second to maximize muscle fiber activation. Children will be shown test conduct prior to starting three trials. For the tibialis anterior muscle test, children will lay on a plinth with legs restrained and push against a device with their foot. Assessing ankle muscle groups, especially plantar flexors and dorsiflexors, is crucial for understanding power generation in walking and gait speed, particularly in stroke patients, while testing positions will be optimized for clinical feasibility.	at baseline and after 8 weeks

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2026
• Primary Completion (Actual): June 5, 2026
• Study Completion (Estimated): July 5, 2026

Study Registration Dates

• First Submitted: June 10, 2026
• First Submitted That Met QC Criteria: June 10, 2026
• First Posted (Actual): June 15, 2026

Study Record Updates

• Last Update Posted (Actual): June 15, 2026
• Last Update Submitted That Met QC Criteria: June 10, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Paresis
• Other Study ID Numbers: Nourhan_Msc

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No