TENS With Proprioceptive-Visual Training on Gait Parameters in CP

NCT07338994 | Completed DMC

• 1 other identifier: P.T.REC/012/006102
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cerebral Palsy (CP)

Keywords

Spastic diplegia; visual training; proprioceptive stimulation; gait; Tekscan Walkway; TENS

Outcome Measures

Primary Outcomes (5)

• cadence

  investigators measure cadence

  8 weeks

• step length and width

  investigators measure step length, width

  8 weeks

• gait velocity

  investigators measure gait velocity

  8 weeks

• gait time

  investigators measure gait time

  8 weeks

• foot angle

  investigators measure foot angle

  8 weeks

Study Arms (2)

control group

PLACEBO COMPARATOR

receive proprioceptive-visual training

Device: 1. Tekscan Walkway system

study group

EXPERIMENTAL

TENS with proprioceptive - visual training

Device: TENS; Device: 1. Tekscan Walkway system

Interventions

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

study group

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).

control group; study group

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university

Giza, 11432, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• mostafa ali, professor

  associate professor for pediatrics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: faculty of physical therapy, cairo university

Model Details: 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

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 14, 2026
• Study Start: April 10, 2025
• Primary Completion: July 20, 2025
• Study Completion: September 1, 2025
• Last Updated: January 14, 2026

Record last verified: 2026-01

Locations

EG (1)