- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07338994
TENS With Proprioceptive-Visual Training on Gait Parameters in CP
January 7, 2026 updated by: Mostafa S Ali, Cairo University
TENS With Proprioceptive-Visual Training on Gait Parameters in Children With Spastic Diplegic Cerebral Palsy: A Randomized Controlled Trial
This study aimed to evaluate the effect of TENS with proprioceptive - visual training on gait parameters in children with spastic diplegic cerebral palsy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Giza, Egypt, 11432
- Cairo University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: control group
receive proprioceptive-visual training
|
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).
|
|
Experimental: study group
TENS with proprioceptive - visual training
|
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).
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
cadence
Time Frame: 8 weeks
|
investigators measure cadence
|
8 weeks
|
|
step length and width
Time Frame: 8 weeks
|
investigators measure step length, width
|
8 weeks
|
|
gait velocity
Time Frame: 8 weeks
|
investigators measure gait velocity
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8 weeks
|
|
gait time
Time Frame: 8 weeks
|
investigators measure gait time
|
8 weeks
|
|
foot angle
Time Frame: 8 weeks
|
investigators measure foot angle
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: mostafa ali, professor, associate professor for pediatrics
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 10, 2025
Primary Completion (Actual)
July 20, 2025
Study Completion (Actual)
September 1, 2025
Study Registration Dates
First Submitted
December 19, 2025
First Submitted That Met QC Criteria
January 7, 2026
First Posted (Actual)
January 14, 2026
Study Record Updates
Last Update Posted (Actual)
January 14, 2026
Last Update Submitted That Met QC Criteria
January 7, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/006102
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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