NCT07606222

Brief Summary

This study was conducted to compare between the effect of neuromuscular electrical stimulation and myofeedback on upper limb function, muscle activity and brain derived neurotropic factor in blood for children with hemiplegia after brain tumor surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

July 1, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 26, 2026

Completed
Last Updated

May 26, 2026

Status Verified

May 1, 2026

Enrollment Period

11 months

First QC Date

May 17, 2026

Last Update Submit

May 17, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Assessment of muscle activity

    All children will be assessed using surface electromyography for wrist extensor muscles while sitting, with their upper limbs resting on a desk and utilizing three electrodes. The ground electrode (black) is placed proximal to the others, the active electrode (yellow) is on the common extensor origin, and the connector (blue) is positioned at least 3 cm distally. After registering new patient data, the assessment begins via a one-channel surface electromyography setup, recording maximum and mean muscle activity during wrist extension upon pressing the play button.

    at baseline and after 12 weeks

Secondary Outcomes (3)

  • Assessment of upper limb function

    at baseline and after 12 weeks

  • assessment of level of neurotrophic factor

    at baseline and after 12 weeks

  • assessment of dynamic spasticity of wrist and elbow flexors muscles

    at baseline and after 12 weeks

Study Arms (3)

selected physical therapy program

ACTIVE COMPARATOR

The control group will undergo a selected physical therapy (PT) program for one hour, three times weekly, over twelve weeks.

Other: selected physical therapy program

selected physical therapy program and biofeedback

EXPERIMENTAL

Patient will undergo a selected physical therapy program for one hour, three times a week, for twelve weeks, supplemented by a biofeedback program.

Other: selected physical therapy programDevice: biofeedback

selected physical therapy program and neuromuscular electric stimulation

EXPERIMENTAL

The child will participate in a physical therapy program for one hour, three times a week, over twelve weeks, supplemented by neuromuscular electric stimulation.

Other: selected physical therapy programDevice: neuromuscular electric stimulation

Interventions

The program includes push-up exercises, active strength training for wrist extensors using fine motor toys, stretching for wrist and elbow flexors and pronators, weight-bearing positions from side sitting, quadruped position with active limb elevation, rolling a small ball with the affected limb, and rhythmic muscle approximation for shoulder, elbow, and wrist.

selected physical therapy programselected physical therapy program and biofeedbackselected physical therapy program and neuromuscular electric stimulation

During sessions, the child sits with an arm resting on a table, with electrodes placed on the wrist extensors and forearm. The treatment involves gradually increasing the intensity of faradic current to induce muscle contraction. Each session lasts 30 minutes to one hour, with treatments up to three times daily, using a frequency of 50-100 Hz and a pulse duration of 0.1-1 ms, for a duration of 2 weeks to 3 months.

selected physical therapy program and biofeedback

The child will participate in a physical therapy program for one hour, three times a week, over twelve weeks, supplemented by neuromuscular electric stimulation. During sessions, the child sits with an arm resting on a table, with electrodes placed on the wrist extensors and forearm. The treatment involves gradually increasing the intensity of faradic current to induce muscle contraction. Each session lasts 30 minutes to one hour, with treatments up to three times daily, using a frequency of 50-100 Hz and a pulse duration of 0.1-1 ms, for a duration of 2 weeks to 3 months.

selected physical therapy program and neuromuscular electric stimulation

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age 6-14 years post brain tumor surgery children.
  • Children's hand use experience questionnaire between 25 and 50 on a scale of units.
  • Grade 2 muscle power of wrist, elbow and finger extensors.
  • Outpatient children.
  • Post-operative brain tumour, which is located in one of the two hemispheres.
  • After 6 weeks post-surgery.
  • The child can follow orders and instructions.

You may not qualify if:

  • Blindness.
  • Deaf child.
  • Skin diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elmagd physical therapy centres, Teriaq oncology centre and Elite hospital.

Alexandria, Egypt

Location

MeSH Terms

Conditions

Hemiplegia

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, Psychological

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

May 17, 2026

First Posted

May 26, 2026

Study Start

July 1, 2024

Primary Completion

June 1, 2025

Study Completion

September 1, 2025

Last Updated

May 26, 2026

Record last verified: 2026-05

Locations