Effect of Task Oriented Training With Functional Electrical Stimulation on Balance in Children With Hemiparesis
10 juni 2026 uppdaterad av: 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.
Studieöversikt
Status
Rekrytering
Betingelser
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
36
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Nourhan Reda Abdel Razek Dawood, physical therapist
- Telefonnummer: 01017173755
- E-post: Eman_pediatrics2016@yahoo.com
Studieorter
-
-
-
Damietta, Egypten
- Rekrytering
- Damietta general hospital.
-
Kontakt:
- Nourhan Reda Abdel Razek Dawood, physical therapist
- Telefonnummer: 01017173755
- E-post: Eman_pediatrics2016@yahoo.com
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
Tar emot friska volontärer
Nej
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: conventional exercise program
The control group consist of 18 children will receive conventional exercise program for 60 min.
|
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.
|
|
Experimentell: 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.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Assessment of balance
Tidsram: at baseline and after 8 weeks
|
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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Assessment of muscle strength
Tidsram: at baseline and after 8 weeks
|
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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
5 april 2026
Primärt slutförande (Faktisk)
5 juni 2026
Avslutad studie (Beräknad)
5 juli 2026
Studieregistreringsdatum
Först inskickad
10 juni 2026
Först inskickad som uppfyllde QC-kriterierna
10 juni 2026
Första postat (Faktisk)
15 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
15 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
10 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Nourhan_Msc
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .