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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07648511
Enrollment
36
Registered
2026-06-15
Start date
2026-04-05
Completion date
2026-07-05
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children, Only, Hemiparesis

Brief summary

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.

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.

Interventions

OTHERSelected 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.

OTHERSelected 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.

DEVICESelected 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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
6 Years to 9 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Assessment of balanceat baseline and after 8 weeksPediatric 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

Secondary

MeasureTime frameDescription
Assessment of muscle strengthat baseline and after 8 weeksEach 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.

Countries

Egypt

Contacts

CONTACTNourhan Reda Abdel Razek Dawood, physical therapist
Eman_pediatrics2016@yahoo.com01017173755

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 16, 2026