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

ConditionsHemiparesis Children, Only

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age6-9

SponsorCairo University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The age of the selected children will be ranged from 6 to 9 years.

Able to follow simple instructions.

Degree of spasticity is ranging from 1to 1+ according to modified Ashworth scale.

The level of motor function of the children will be levels I-II according to Gross Motor Function Classification System.

Disqualifiers

Visual, hearing disorders.

Recent Botox injection or orthopedic surgery in the lower limb in the last 6 months before the start of the study.

Any fixed deformity of lower limb.

Trial design

Design model

Parallel

Treatments tested in this trial

Selected therapeutic program
Other intervention
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.
Selected Task oriented training program
Other intervention
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.
Selected Functional electrical stimulation
Device
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.

Treatment groups

36 Participants

are divided into 2 treatment groups

Group A: conventional exercise programActive comparator 1 intervention

Group B: task-oriented trainingExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

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

Time frame

at baseline and after 8 weeks

Secondary outcomes

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.

Time frame

at baseline and after 8 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

Apply now