NCT07648511

Brief Summary

To investigate the efficacy of combination of task-oriented training and Functional electrical stimulation of ankle dorsiflexor muscles on:

  1. 1.Strength of ankle muscles in children with hemiparesis.
  2. 2.Balance in children with hemiparesis.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress79%
Apr 2026Jul 2026

Study Start

First participant enrolled

April 5, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2026

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 15, 2026

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2026

Expected
Last Updated

June 15, 2026

Status Verified

June 1, 2026

Enrollment Period

2 months

First QC Date

June 10, 2026

Last Update Submit

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 COMPARATOR

The control group consist of 18 children will receive conventional exercise program for 60 min.

Other: Selected therapeutic program

task-oriented training

EXPERIMENTAL

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.

Other: Selected therapeutic programOther: Selected Task oriented training programDevice: Selected Functional electrical stimulation

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.

conventional exercise programtask-oriented training

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.

task-oriented training

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.

task-oriented training

Eligibility Criteria

Age6 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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

Study Sites (1)

Damietta general hospital.

Damietta, Egypt

RECRUITING

MeSH Terms

Conditions

Paresis

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Nourhan Reda Abdel Razek Dawood, physical therapist

CONTACT

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

Locations