Cerebral Palsy (CP)NCT07338994
TENS With Proprioceptive-Visual Training on Gait Parameters in CP
A study testing TENS and 1. Tekscan Walkway system in people with Cerebral Palsy (CP), run by Cairo University at 1 site in Egypt.
Trial summary
This study aimed to evaluate the effect of TENS with proprioceptive - visual training on gait parameters in children with spastic diplegic cerebral palsy. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy (CP)
- What is being tested?
- TENS and 1. Tekscan Walkway system
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Apr 2025to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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)
- Being tested
- TENS, 1. Tekscan Walkway system
- Keywords
- Spastic diplegia, visual training, proprioceptive stimulation, gait, Tekscan Walkway, TENS
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENSDevice
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 systemDevice
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 | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | receive proprioceptive-visual training Receives: Device: 1. Tekscan Walkway system |
| study group | Experimental | TENS with proprioceptive - visual training Receives: Device: TENS; Device: 1. Tekscan Walkway system |
What is being measured
The primary outcome is the main question the study is designed to answer.
cadence
investigators measure cadence
Measured: 8 weeks
step length and width
investigators measure step length, width
Measured: 8 weeks
gait velocity
investigators measure gait velocity
Measured: 8 weeks
gait time
investigators measure gait time
Measured: 8 weeks
foot angle
investigators measure foot angle
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start10 Apr 2025
- Primary completion20 Jul 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa S Ali, Cairo University
- Investigators
- mostafa ali, professor, Principal investigator, associate professor for pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07338994
- Sponsor's protocol ID
- P.T.REC/012/006102
- Status last verified
- Jan 2026
- First submitted
- 19 Dec 2025
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TENS With Proprioceptive-Visual Training on Gait Parameters in Children With Spastic Diplegic Cerebral Palsy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07338994
- Acronym / sponsor ID
- P.T.REC/012/006102
- Conditions
- Cerebral Palsy (CP)
- Keywords
- Spastic diplegia, visual training, proprioceptive stimulation, gait, Tekscan Walkway, TENS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 20 Jul 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Device: 1. Tekscan Walkway systemreceive proprioceptive-visual training |
| study group | Experimental | Device: TENS, Device: 1. Tekscan Walkway systemTENS with proprioceptive - visual training |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TENSElectrical 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 | Device | study group |
| 1. Tekscan Walkway systemIt 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). | Device | control group, study group |
Primary outcome
cadence
Time frame: 8 weeks
investigators measure cadence
step length and width
Time frame: 8 weeks
investigators measure step length, width
gait velocity
Time frame: 8 weeks
investigators measure gait velocity
gait time
Time frame: 8 weeks
investigators measure gait time
foot angle
Time frame: 8 weeks
investigators measure foot angle
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Virtual Reality Vs Postural Control Training in Children With Cerebral Palsy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
mostafa ali, professor principal investigator
associate professor for pediatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TENS and 1. Tekscan Walkway system in people with Cerebral Palsy (CP), run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cadence (time frame: 8 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026; AzTrials last refreshed its copy on 1 Nov 2026.