Effect of Task Oriented Training With Functional Electrical Stimulation on Balance in Children With Hemiparesis
10 juni 2026 bijgewerkt door: Eman Kamal Abdelmoteleb, Cairo University
To investigate the efficacy of combination of task-oriented training and Functional electrical stimulation of ankle dorsiflexor muscles on:
- Strength of ankle muscles in children with hemiparesis.
- Balance in children with hemiparesis.
Studie Overzicht
Toestand
Werving
Conditie
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Geschat)
36
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Nourhan Reda Abdel Razek Dawood, physical therapist
- Telefoonnummer: 01017173755
- E-mail: Eman_pediatrics2016@yahoo.com
Studie Locaties
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Damietta, Egypte
- Werving
- Damietta general hospital.
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Contact:
- Nourhan Reda Abdel Razek Dawood, physical therapist
- Telefoonnummer: 01017173755
- E-mail: Eman_pediatrics2016@yahoo.com
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusion Criteria:
- 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.
Exclusion Criteria:
The children will be excluded if they have one or more of the following criteria:
- 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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: conventional exercise program
The control group consist of 18 children will receive conventional exercise program for 60 min.
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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.
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Experimenteel: 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.
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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.
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.
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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Assessment of balance
Tijdsspanne: at baseline and after 8 weeks
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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
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at baseline and after 8 weeks
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Assessment of muscle strength
Tijdsspanne: at baseline and after 8 weeks
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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.
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at baseline and after 8 weeks
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
5 april 2026
Primaire voltooiing (Werkelijk)
5 juni 2026
Studie voltooiing (Geschat)
5 juli 2026
Studieregistratiedata
Eerst ingediend
10 juni 2026
Eerst ingediend dat voldeed aan de QC-criteria
10 juni 2026
Eerst geplaatst (Werkelijk)
15 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
15 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
10 juni 2026
Laatst geverifieerd
1 juni 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Nourhan_Msc
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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