TENS With Proprioceptive-Visual Training on Gait Parameters in CP

NCT ID: NCT07338994

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-10
• Study Completion Date: 2025-09-01

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.

Detailed Description

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.

Conditions

Cerebral Palsy (CP)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

control group

receive proprioceptive-visual training

Group Type: PLACEBO_COMPARATOR

1. Tekscan Walkway system

Intervention Type: 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).

study group

TENS with proprioceptive - visual training

Group Type: EXPERIMENTAL

TENS

Intervention Type: 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

Intervention Type: 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).

Interventions

TENS

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

Intervention Type: DEVICE

1. Tekscan Walkway system

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).

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mostafa S Ali

faculty of physical therapy, cairo university

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

mostafa ali, professor

Role: PRINCIPAL_INVESTIGATOR

associate professor for pediatrics

Locations

Cairo university

Giza, , Egypt

Countries

Egypt

Other Identifiers

P.T.REC/012/006102

Identifier Type: -

Identifier Source: org_study_id