Effect of Task Oriented Training With Functional Electrical Stimulation on Balance in Children With Hemiparesis
1 other identifier
interventional
36
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 5, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 5, 2026
CompletedFirst Submitted
Initial submission to the registry
June 10, 2026
CompletedFirst Posted
Study publicly available on registry
June 15, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
July 5, 2026
ExpectedJune 15, 2026
June 1, 2026
2 months
June 10, 2026
June 10, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Assessment of muscle strength
at baseline and after 8 weeks
Study Arms (2)
conventional exercise program
ACTIVE COMPARATORThe control group consist of 18 children will receive conventional exercise program for 60 min.
task-oriented training
EXPERIMENTALStudy 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Damietta general hospital.
Damietta, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 10, 2026
First Posted
June 15, 2026
Study Start
April 5, 2026
Primary Completion
June 5, 2026
Study Completion (Estimated)
July 5, 2026
Last Updated
June 15, 2026
Record last verified: 2026-06