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Completed

NCT Number: NCT07338994

TENS With Proprioceptive-Visual Training on Gait Parameters in CP

This study aimed to evaluate the effect of TENS with proprioceptive - visual training on gait parameters in children with spastic diplegic cerebral palsy.

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Key information

Conditions

Cerebral Palsy (CP) Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Nervous System Diseases

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo university

Giza, 11432, Egypt

About this study

Two groups of thirty diplegic CP children, ages 4 to 6, were randomly assigned to receive proprioceptive-visual training as the control group and TENS with proprioceptive - visual training as the research group. For eight weeks, both groups received therapy three times a week. Prior to and during the intervention period, each participant had an evaluation by gait analysis.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diplegic CP children who were between the ages of 4 and 6 years
  • spasticity grades were 1 and 1+ according to modified Ashworth Scale
  • gross motor function classification system at level II and III

Exclusion criteria

  • Children who have visual impairments, hearing damage
  • received Botulinum Toxin injections or oral antispasticity medications within the past 6 months
  • fixed deformities at lower limbs
  • inability to understand the task

Treatment and study plan

TENS

Device

Electrical stimulation will be delivered by means of self-adherent surface electrodes (Encore plus), using a programmable electrical stimulator, providing monophasic rectangular pulse trains. Electrodes were attached over the belly of the rectus femoris and tibialis anterior muscles. The quadriceps and the dorsiflexors were selected due to their dominance in establishing a normal and efficient gait. TENS was applied for 20 minutes during gait training. The parameters selected for the electrical stimulation will be as follows: frequency 20Hz, pulse-width 0.25 msec, and intensity will be individually adjusted for each subject

1. Tekscan Walkway system

Device

It includes sensors (4 sensels/cm2) with a resolution of up to 185 Hz, a digital mat (195.5 cm long by 44.2 cm wide) placed in a wooden pathway, and a pressure sensor (1 to 862 kPa). The plasma screen faces the walkway and is 1.5 meters high and 7 meters away. It displays pictures that are mirrored from seven pressure points (forming the contour of the foot). if the foot's heel, midfoot, forefoot, fifth metatarsal, third-fourth, second, and first metatarsals are the seven areas of pressure. Data such as maximum peak pressure (kPa), stance time (s), cadence, gait time (s), distance (cm), velocity (cm/s), and transmission hardware (cable and sensor-interface or so-called handle) will be extrapolated using a computer running The Tekscan Software (version 7).

Primary outcomes

  1. cadence

    Time frame: 8 weeks

    investigators measure cadence

  2. step length and width

    Time frame: 8 weeks

    investigators measure step length, width

  3. gait velocity

    Time frame: 8 weeks

    investigators measure gait velocity

  4. gait time

    Time frame: 8 weeks

    investigators measure gait time

  5. foot angle

    Time frame: 8 weeks

    investigators measure foot angle

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

TENS With Proprioceptive-Visual Training on Gait Parameters in Children With Spastic Diplegic Cerebral Palsy: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 14, 2026
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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