ParaparesisEMT-BGNCT07196956
Effect of Electromagnetic Field Therapy on Balance and Gait in Paraparetic Patients
A study testing Low-Frequency Electromagnetic Field Therapy (0.5 Hz) in people with Paraparesis and Gait Disorders, Neurologic, run by MTI University at 1 site in Saudi Arabia.
Trial summary
This study will investigate whether adding electromagnetic field therapy (EMT) to a standard physical therapy program is more effective than physical therapy alone for improving balance and walking ability in paraparetic patients. Read more about this study
- Who is it for?
- Ages 15 to 45 years
- Conditions the study is for
- Paraparesis, Gait Disorders, Neurologic, Postural Balance Disorders
- What is being tested?
- Low-Frequency Electromagnetic Field Therapy (0.5 Hz)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 11 Jan 2026to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 15 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of paraparesis with spinal cord lesion level between T6 and T12. Age between 25 and 45 years. Muscle spasticity graded as II or III on the Modified Ashworth Scale (MAS) for hip adductors and ankle plantar flexors.
- Medically and psychologically stable. Conscious and cooperative, able to follow instructions. Able to provide informed consent.
Who cannot join
- Presence of metal implants or pacemakers (contraindicated for electromagnetic therapy).
- History of seizures or epilepsy. Active malignancy or infection. Severe cognitive or psychiatric impairment that would interfere with participation.
- Use of alcohol or recreational drugs during the study period. Participation in another concurrent physical or electromagnetic therapy trial. Unstable medical condition (e.g., uncontrolled hypertension, cardiovascular disease).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site
Outpatient Clinic, Department of Physical Therapy, Faculty of Applied Medical Science, Najran University
Najran
reda kotb abdelrazik, phd, +966 53476201, dr_reda_kotb@yahoo.com
About this study
Official title: The Role of Electromagnetic Field Therapy in Improving Perturbation of Balance and Gait Disorders in Paraparetic Patients
This study will investigate whether adding electromagnetic field therapy (EMT) to a standard physical therapy program is more effective than physical therapy alone for improving balance and walking ability in paraparetic patients.
Thirty patients with paraparesis (weakness in the lower limbs) due to spinal cord lesions between levels T6 and T12 will be randomly assigned to one of two groups. Both groups will receive a 45-minute physical therapy session, three times per week for two months. The physical therapy program will include stretching, strengthening, balance, and gait training exercises.
Read more
The key difference will be that one group (Group II) will also receive active low-frequency (0.5 Hz) electromagnetic therapy applied to their spine during their sessions, while the other group (Group I) will receive a placebo (inactive) EMT device.
Patients will be assessed before and after the 2-month treatment period. The assessments will measure muscle spasticity (using the Modified Ashworth Scale), balance (using the Biodex Balance System), and detailed gait parameters like step length, stride length, and base of support (using a 3D motion analysis system
- Being tested
- Low-Frequency Electromagnetic Field Therapy (0.5 Hz), Placebo Electromagnetic Field Therapy
- Keywords
- Electromagnetic Field Therapy, Electromagnetic Stimulation, Physical Therapy Modalities, Spasticity, Rehabilitation, Biodex Balance System, Motion Analysis, Modified Ashworth Scale
- Medical subject headings
- Paraparesis, Gait Disorders, Neurologic, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Frequency Electromagnetic Field Therapy (0.5 Hz)Device
Also called EMT,, Pulsed Electromagnetic Field Therapy
Active electromagnetic field therapy delivered via a PMT Quattro PRO device (Italy, 2002). Settings: 0.5 Hz frequency, 30 mA intensity, applied for 20 minutes per session to the spinal lesion level (T6-T12) while patient is prone. Followed by 10-minute rest. Administered three times per week for 2 months, in conjunction with a standardized 45-minute physical therapy program (stretching, strengthening, balance, and gait training).
Placebo Electromagnetic Field TherapyDevice
Also called Sham EMT, Inactive EMT
identical-appearing electromagnetic therapy device with no active field output (placebo/sham). Applied for 20 minutes per session to the spinal lesion level (T6-T12) while patient is prone. Followed by 10-minute rest. Administered three times per week for 2 months, in conjunction with the identical standardized 45-minute physical therapy program (stretching, strengthening, balance, and gait training) as the active EMT group.
| Study group | Role | What they receive |
|---|---|---|
| Placebo EMT + Physical Therapy | Placebo comparator | Participants will receive a placebo (inactive) electromagnetic therapy device applied to the spine, combined with a standardized 45-minute physical therapy program. The physical therapy program includes stretching exercises, strengthening exercises, balance training, and gait training. Treatment will be administered three times per week for 2 months. Receives: Device: Placebo Electromagnetic Field Therapy |
| Active EMT + Physical Therapy | Experimental | ticipants will receive active low-frequency (0.5 Hz) electromagnetic field therapy applied to the spine, combined with the identical 45-minute physical therapy program (stretching, strengthening, balance, and gait training) as the control group. Treatment will be administered three times per week for 2 months. Receives: Device: Low-Frequency Electromagnetic Field Therapy (0.5 Hz) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Muscle Spasticity as Measured by the Modified Ashworth Scale (MAS)
Spasticity of the hip adductor and ankle plantar flexor muscles will be assessed using the Modified Ashworth Scale (MAS), a 6-point ordinal scale (0 = no increase in muscle tone to 4 = rigid in flexion or extension). The primary comparison will be the change in MAS score from baseline to 2 months between the active EMT group and the placebo EMT group.
Measured: Baseline (pre-treatment) and at 2 months (post-treatment)
Secondary outcomes (4)
Change in Dynamic Balance as Measured by the Biodex Balance System (BBS)
Dynamic postural stability will be assessed using the Biodex Balance System. Participants will perform a single-leg stance test (on the non-dominant leg, eyes closed, hands on hips). The system provides a numerical stability index; a lower score indicates better balance. Change from baseline to 2 months will be compared between groups.
Measured: Baseline (pre-treatment) and at 2 months (post-treatment)
Change in Step Length as Measured by 3D Motion Analysis (Qualisys System)
Step length (distance from heel strike of one foot to heel strike of the opposite foot) will be measured during self-paced walking using the Qualisys 3D Motion Analysis System. The average of three trials will be recorded. Change from baseline to 2 months will be compared between groups
Measured: Step length (distance from heel strike of one foot to heel strike of the opposite foot) will be measured during self-paced walking using the Qualisys 3D Motion Analysis System. The average of three trials will be recorded. Change from baseline to 2 month
Change in Stride Length as Measured by 3D Motion Analysis (Qualisys System)
Stride length (distance from heel strike of one foot to the next heel strike of the same foot) will be measured during self-paced walking using the Qualisys 3D Motion Analysis System. The average of three trials will be recorded. Change from baseline to 2 months will be compared between groups.
Measured: Baseline (pre-treatment) and at 2 months (post-treatment)
Change in Base of Support as Measured by 3D Motion Analysis (Qualisys System)
Base of support (lateral distance between the left and right feet during walking) will be measured during self-paced walking using the Qualisys 3D Motion Analysis System. The average of three trials will be recorded. Change from baseline to 2 months will be compared between groups.
Measured: Baseline (pre-treatment) and at 2 months (post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start11 Jan 2026 (estimated)
- Primary completion28 Feb 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParaparesisStudies of the same condition, open and under way.
- 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
- Thirty paraparetic patients will be randomly assigned to one of two parallel groups. Group I will receive a placebo electromagnetic therapy device plus a standard physical therapy program. Group II will receive active electromagnetic field therapy plus the identical physical therapy program.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MTI University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, reda abd elrazik, MTI University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07196956
- Sponsor's protocol ID
- PT. BU. EC. 28
- Acronym
- EMT-BG
- Status last verified
- Jan 2026
- First submitted
- 20 Sep 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- 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 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Electromagnetic Field Therapy in Improving Perturbation of Balance and Gait Disorders in Paraparetic Patients
- ClinicalTrials.gov ID
- NCT07196956
- Acronym / sponsor ID
- EMT-BG / PT. BU. EC. 28
- Keywords
- Electromagnetic Field Therapy, Electromagnetic Stimulation, Physical Therapy Modalities, Spasticity, Rehabilitation, Biodex Balance System, Motion Analysis, Modified Ashworth Scale
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- MTI UniversityUniversity, hospital or other
- Study start
- 11 Jan 2026 (estimated)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 29 Sep 2025 (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 will investigate whether adding electromagnetic field therapy (EMT) to a standard physical therapy program is more effective than physical therapy alone for improving balance and walking ability in paraparetic patients.
Thirty patients with paraparesis (weakness in the lower limbs) due to spinal cord lesions between levels T6 and T12 will be randomly assigned to one of two groups. Both groups will receive a 45-minute physical therapy session, three times per week for two months. The physical therapy program will include stretching, strengthening, balance, and gait training exercises.
The key difference will be that one group (Group II) will also receive active low-frequency (0.5 Hz) electromagnetic therapy applied to their spine during their sessions, while the other group (Group I) will receive a placebo (inactive) EMT device.
Patients will be assessed before and after the 2-month treatment period. The assessments will measure muscle spasticity (using the Modified Ashworth Scale), balance (using the Biodex Balance System), and detailed gait parameters like step length, stride length, and base of support (using a 3D motion analysis system
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Thirty paraparetic patients will be randomly assigned to one of two parallel groups. Group I will receive a placebo electromagnetic therapy device plus a standard physical therapy program. Group II will receive active electromagnetic field therapy plus the identical physical therapy program.
| Arm | Type | Receives |
|---|---|---|
| Placebo EMT + Physical Therapy | Placebo comparator | Device: Placebo Electromagnetic Field TherapyParticipants will receive a placebo (inactive) electromagnetic therapy device applied to the spine, combined with a standardized 45-minute physical therapy program. The physical therapy program includes stretching exercises, strengthening exercises, balance training, and gait training. Treatment will be administered three times per week for 2 months. |
| Active EMT + Physical Therapy | Experimental | Device: Low-Frequency Electromagnetic Field Therapy (0.5 Hz)ticipants will receive active low-frequency (0.5 Hz) electromagnetic field therapy applied to the spine, combined with the identical 45-minute physical therapy program (stretching, strengthening, balance, and gait training) as the control group. Treatment will be administered three times per week for 2 months. |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Diagnosis of paraparesis with spinal cord lesion level between T6 and T12. Age between 25 and 45 years. Muscle spasticity graded as II or III on the Modified Ashworth Scale (MAS) for hip adductors and ankle plantar flexors.
- Medically and psychologically stable. Conscious and cooperative, able to follow instructions. Able to provide informed consent.
Key exclusion criteria (3 listed)
- Presence of metal implants or pacemakers (contraindicated for electromagnetic therapy).
- History of seizures or epilepsy. Active malignancy or infection. Severe cognitive or psychiatric impairment that would interfere with participation.
- Use of alcohol or recreational drugs during the study period. Participation in another concurrent physical or electromagnetic therapy trial. Unstable medical condition (e.g., uncontrolled hypertension, cardiovascular disease).
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 |
|---|---|---|
| Low-Frequency Electromagnetic Field Therapy (0.5 Hz)Also: EMT,, Pulsed Electromagnetic Field TherapyActive electromagnetic field therapy delivered via a PMT Quattro PRO device (Italy, 2002). Settings: 0.5 Hz frequency, 30 mA intensity, applied for 20 minutes per session to the spinal lesion level (T6-T12) while patient is prone. Followed by 10-minute rest. Administered three times per week for 2 months, in conjunction with a standardized 45-minute physical therapy program (stretching, strengthening, balance, and gait training). | Device | Active EMT + Physical Therapy |
| Placebo Electromagnetic Field TherapyAlso: Sham EMT, Inactive EMTidentical-appearing electromagnetic therapy device with no active field output (placebo/sham). Applied for 20 minutes per session to the spinal lesion level (T6-T12) while patient is prone. Followed by 10-minute rest. Administered three times per week for 2 months, in conjunction with the identical standardized 45-minute physical therapy program (stretching, strengthening, balance, and gait training) as the active EMT group. | Device | Placebo EMT + Physical Therapy |
Primary outcome
Change in Muscle Spasticity as Measured by the Modified Ashworth Scale (MAS)
Time frame: Baseline (pre-treatment) and at 2 months (post-treatment)
Spasticity of the hip adductor and ankle plantar flexor muscles will be assessed using the Modified Ashworth Scale (MAS), a 6-point ordinal scale (0 = no increase in muscle tone to 4 = rigid in flexion or extension). The primary comparison will be the change in MAS score from baseline to 2 months between the active EMT group and the placebo EMT group.
4 secondary outcomes
Change in Dynamic Balance as Measured by the Biodex Balance System (BBS)
Time frame: Baseline (pre-treatment) and at 2 months (post-treatment)
Change in Step Length as Measured by 3D Motion Analysis (Qualisys System)
Time frame: Step length (distance from heel strike of one foot to heel strike of the opposite foot) will be measured during self-paced walking using the Qualisys 3D Motion Analysis System. The average of three trials will be recorded. Change from baseline to 2 month
Change in Stride Length as Measured by 3D Motion Analysis (Qualisys System)
Time frame: Baseline (pre-treatment) and at 2 months (post-treatment)
Change in Base of Support as Measured by 3D Motion Analysis (Qualisys System)
Time frame: Baseline (pre-treatment) and at 2 months (post-treatment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Frequency Electromagnetic Field Therapy (0.5 Hz) in people with Paraparesis and Gait Disorders, Neurologic, run by MTI University at 1 site in Saudi Arabia.
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 2 inclusion and 3 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: opening soon, as of the sponsor's last update on 5 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 Saudi Arabia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reda kotb Abdelrazik, Ph.D. (+966 53 247 6201, dr_reda_kotb@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Muscle Spasticity as Measured by the Modified Ashworth Scale (MAS) (time frame: Baseline (pre-treatment) and at 2 months (post-treatment)). 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 5 Jan 2026.