StrokeNCT06562530
Effect of High Tone Power Therapy on Spasticity and Gait Kinematics in Stroke Patients
A study testing high tone power therapy, transcutaneous electrical nerve stimulation (TENS) and selected physical therapy program in people with Stroke, run by Cairo University at 1 site in Egypt.
Trial summary
This study aims to compare between High tone power therapy (modulated frequency current) and Transcutaneous electrical nerve stimulation (fixed frequency current) on spasticity and selected kinematic gait parameters in stroke patients. Read more about this study
- Who is it for?
- Ages 45 to 60 years
- Conditions the study is for
- Stroke
- What is being tested?
- high tone power therapy, transcutaneous electrical nerve stimulation (TENS) and selected physical therapy program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to Dec 2024
- 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 45 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Duration of illness not less than six months post-stroke (Hillis A. et al., 2006).
- Patients' age ranges from forty-five to sixty-five years (Feigin et al., 2022).
- Body mass index from (18.5 to 24.9).
- Patients can respond to verbal instructions (Consciousness and orientation to time, place, and person) more than 13 degrees on the Glasco coma scale (Hegazy et al., 2020).
- Able to walk independently on an even surface without any assistive device (Fan and Yin, 2013).
- Patients with moderate Spasticity of the ankle joint (grade 2 and 3 According to Modified Ashworth Scale) (Hegazy et al., 2020).
Who cannot join
- Subjects with any other Co-existing Progressive neurological disorder (Hegazy et al., 2020).
- Unstable Cardiac condition (E.g., Acute Myocardial infarction, severe Cardiac Failure) (Teslim et al., 2013).
- Subjects with any anti-spastic Drugs (Chang et al., 2013).
- Musculoskeletal disorders affecting gait kinematics such as severe arthritis, knee surgery, and total hip joint replacement, lower limb fractures less than 6 months or contractures of fixed deformity, leg length discrepancy.
- Any previous Contracture or deformities (Hegazy et al., 2020).
- Un co-operative patients (Gupta and Chatterjee, 2019).
Show all 9Show fewer
- Open wounds, burns, or Loss of sensation (Grevstad et al., 2016).
- Patients with metal implants (von Lewinski et al., 2009).
- Visual, auditory problems.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Tone Power Therapy Versus Transcutaneous Electrical Nerve Stimulation on Spasticity and Selected Kinematic Gait Parameters in Stroke Patients
This study aims to compare between High tone power therapy (modulated frequency current) and Transcutaneous electrical nerve stimulation (fixed frequency current) on spasticity and selected kinematic gait parameters in stroke patients.
Read the detailed description
Stroke is a neurological deficit attributed to an acute focal injury of the central nervous system (CNS) by a vascular cause . Stroke is one of the leading causes of disability and mortality in the globe, stroke occurs when blood flow to the brain is restricted due to a blocked or ruptured artery; the cerebral energy supply is interrupted, resulting in tissue destruction and widespread neuronal, cognitive impairments, and psychological morbidity .
Stroke is the second major cause of death and disability worldwide with over 13 million new cases annually . Stroke has been described as a major source of both mortality and global disability . Approximately 795,000 people experience stroke annually, and 60% (or 465,000) of them need rehabilitation .
Spasticity is a symptom of stroke, brain and spinal cord damage, multiple sclerosis, cerebral palsy, and other neurological illnesses that cause paralysis . The most common spastic pattern in the lower limbs is adduction and extension of the knee with an Equinovarus foot . This impacts gait patterns and daily functioning activities .
Treatment modalities for the management of spasticity include Stretching, splinting, Neuromuscular electrical stimulation (NMES), extracorporeal shock wave therapy, transcranial and spinal cord magnetic stimulation, Surgical treatment, neurectomy, rhizotomy, and myelotomy; also, many drugs used for treating spasticity oral drugs like Baclofen, Tizanidine, and injectable medications like Phenol/alcohol and Botulinum 2 toxin .
Transcutaneous electrical nerve stimulation (TENS) stimulates large diameter mechano-sensitive nerve fibers in the skin it's a non-invasive treatment that has been reported to affect pain control and sensory stimulation which is commonly used in the treatment of chronic and acute pain with possible mechanisms of action including segmental inhibition, the release of endogenous opioids, counter-irritation, nerve conduction block, increase muscle power and movement function .
High-tone power therapy (HTT) is a unique characteristic of electrotherapy. It uses intermediate frequency, metal-compatible alternating current whose frequency oscillates between approximately 4000 Hz and 33000 Hz, and intensity is adjusted, unlike traditional electrotherapies as transcutaneous electrical nerve stimulation (TENS). Its main effects are introducing energy into the body to activate cells, producing an oscillation or vibration in the cells and tissues to promote metabolism, scattering the mediators of pain and inflammation leading to pain relief, and normalizing cell metabolism and nerve regeneration ).
The effective management of spasticity continues to pose challenges to physiotherapy management, there appears to be a dearth of adequate information on high tone power therapy in the management of spasticity; There are several physiotherapy approaches for managing spasticity but there is a lack of evidence to show which is most effective .
Statement of the problem:
This study will answer the following question: Is there any difference between the effect of high-tone power therapy (modulated frequency current) versus transcutaneous electrical nerve stimulation (fixed frequency current) on spasticity and selected kinematic gait parameters in stroke patients?
- Conditions
- Stroke
- Being tested
- high tone power therapy, transcutaneous electrical nerve stimulation (TENS), selected physical therapy program
- Keywords
- high tone power therapy, spatiotemporal gait parameters, gait kinematics
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high tone power therapyDevice
sessions are applied for 30 minutes, 3 times per week, for 3 months
transcutaneous electrical nerve stimulation (TENS)Device
sessions are applied for 30 minutes, 3 times per week, for 3 months
selected physical therapy programOther
sessions are applied for 1 hour, 3 times per week, for 3 months in form o fstretching exercise , range of motion exercises , conventional gait training progressive resistance exercises
| Study group | Role | What they receive |
|---|---|---|
| The control group | Active comparator | 15 patients: receiving 36 sessions of selected physical therapy program for 1 hour 3 times per week for 3 months. Receives: Other: selected physical therapy program |
| The study group1 | Experimental | 15 patients: receiving 36 sessions of High tone power therapy program for 30 minutes and selected physical therapy program for 30 minutes 3 times per week for 3 months (total session: 1 hour). Receives: Device: high tone power therapy; Other: selected physical therapy program |
| The study group 2 | Experimental | 15 patients: receiving 36 sessions of TENS program for 30 minutes and selected physical therapy program for 30 minutes 3 times per week for 3 months (total session: 1 hour). Receives: Device: transcutaneous electrical nerve stimulation (TENS); Other: selected physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Ashworth Scale (MAS)
This scale is used to measure spasticity of Calf muscle in grades from 0 to 5.
Measured: measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention
Computerized electromyography (EMG) using H/M ratio
EMG is an objective device used to measure spasticity of the Soleus muscle in percentage (%)
Measured: measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention
Ten-meter Walk test(10-MWT)
This scale is used to measure walking speed in m/s
- self-selected walking speed (SSWS) in (m/s).
- fastest walking speed (FWS) in (m/s).
Measured: measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention
Time up and go test (TUG)
This test is used to measure time taken by patient to apply sit to stand, walk a distance of 3 meters, turn and walk back to the chair in (sec.)
Measured: measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention
Gait velocity
Gait Analyzer Smart Phone Application is an objective tool that assesses gait velocity (m/s).
Measured: measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention
cadence
Gait Analyzer Smart Phone Application is an objective tool that assesses cadence: the number of steps per second in (steps/ s).
Measured: measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention
step time
Gait Analyzer Smart Phone Application is an objective tool that assesses step time in ( msec.)
Measured: measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention
step time symmetry
Gait Analyzer Smart Phone Application is an objective tool that assesses step time symmetry: the symmetry in time between affected and unaffected lower limbs in percentage (%)
Measured: measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention
step length
Gait Analyzer Smart Phone Application is an objective tool that assesses step length by the inertial sensor system symmetry in meters (m).
Measured: measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention
step length symmetry
Gait Analyzer Smart Phone Application is an objective tool that assesses step length symmetry: the symmetry in step length between affected and unaffected lower limbs in percentage (%)
Measured: measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention
Secondary outcomes (1)
Lafayette Hand-held Dynamometer
This is an objective device used to measure the isometric contraction of dorsi flexors in pounds (lbs.)
Measured: measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start1 Jan 2024
- Primary completionOct 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Randomized controlled trial (RCT). True experimental research design study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jasmine Magdy Mahmoud Abd-elkhalik, Cairo University
- Investigators
- Eman S Fayiz, Professor, Study chair, Cairo UniversityMahmoud Y El-Zanaty, Study chair, Cairo UniversitySandraa M Ahmed, Professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06562530
- Sponsor's protocol ID
- P. T. REC/012/004855
- Status last verified
- Aug 2024
- First submitted
- 14 Aug 2024
- Last updated
- 23 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mahmoud JM, Fayez ES, Ahmed S, Gelany FM, Hassan IM, El-Zanaty MY. Impact of High Tone Power Therapy on Lower Limb Spasticity and Gait Speed in Patients at Least Six Months Post-Stroke: A Randomized Controlled Trial. Physiother Res Int. 2026 Apr;31(2):e70175. doi: 10.1002/pri.70175.
PubMed 41721793
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Tone Power Therapy Versus Transcutaneous Electrical Nerve Stimulation on Spasticity and Selected Kinematic Gait Parameters in Stroke Patients
- ClinicalTrials.gov ID
- NCT06562530
- Acronym / sponsor ID
- P. T. REC/012/004855
- Conditions
- Stroke
- Keywords
- high tone power therapy, spatiotemporal gait parameters, gait kinematics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 20 Aug 2024 (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 aims to compare between High tone power therapy (modulated frequency current) and Transcutaneous electrical nerve stimulation (fixed frequency current) on spasticity and selected kinematic gait parameters in stroke patients.
Detailed description
Stroke is a neurological deficit attributed to an acute focal injury of the central nervous system (CNS) by a vascular cause . Stroke is one of the leading causes of disability and mortality in the globe, stroke occurs when blood flow to the brain is restricted due to a blocked or ruptured artery; the cerebral energy supply is interrupted, resulting in tissue destruction and widespread neuronal, cognitive impairments, and psychological morbidity .
Stroke is the second major cause of death and disability worldwide with over 13 million new cases annually . Stroke has been described as a major source of both mortality and global disability . Approximately 795,000 people experience stroke annually, and 60% (or 465,000) of them need rehabilitation .
Spasticity is a symptom of stroke, brain and spinal cord damage, multiple sclerosis, cerebral palsy, and other neurological illnesses that cause paralysis . The most common spastic pattern in the lower limbs is adduction and extension of the knee with an Equinovarus foot . This impacts gait patterns and daily functioning activities .
Treatment modalities for the management of spasticity include Stretching, splinting, Neuromuscular electrical stimulation (NMES), extracorporeal shock wave therapy, transcranial and spinal cord magnetic stimulation, Surgical treatment, neurectomy, rhizotomy, and myelotomy; also, many drugs used for treating spasticity oral drugs like Baclofen, Tizanidine, and injectable medications like Phenol/alcohol and Botulinum 2 toxin .
Transcutaneous electrical nerve stimulation (TENS) stimulates large diameter mechano-sensitive nerve fibers in the skin it's a non-invasive treatment that has been reported to affect pain control and sensory stimulation which is commonly used in the treatment of chronic and acute pain with possible mechanisms of action including segmental inhibition, the release of endogenous opioids, counter-irritation, nerve conduction block, increase muscle power and movement function .
High-tone power therapy (HTT) is a unique characteristic of electrotherapy. It uses intermediate frequency, metal-compatible alternating current whose frequency oscillates between approximately 4000 Hz and 33000 Hz, and intensity is adjusted, unlike traditional electrotherapies as transcutaneous electrical nerve stimulation (TENS). Its main effects are introducing energy into the body to activate cells, producing an oscillation or vibration in the cells and tissues to promote metabolism, scattering the mediators of pain and inflammation leading to pain relief, and normalizing cell metabolism and nerve regeneration ).
The effective management of spasticity continues to pose challenges to physiotherapy management, there appears to be a dearth of adequate information on high tone power therapy in the management of spasticity; There are several physiotherapy approaches for managing spasticity but there is a lack of evidence to show which is most effective .
Statement of the problem:
This study will answer the following question: Is there any difference between the effect of high-tone power therapy (modulated frequency current) versus transcutaneous electrical nerve stimulation (fixed frequency current) on spasticity and selected kinematic gait parameters in stroke patients?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Randomized controlled trial (RCT). True experimental research design study
| Arm | Type | Receives |
|---|---|---|
| The control group | Active comparator | Other: selected physical therapy program15 patients: receiving 36 sessions of selected physical therapy program for 1 hour 3 times per week for 3 months. |
| The study group1 | Experimental | Device: high tone power therapy, Other: selected physical therapy program15 patients: receiving 36 sessions of High tone power therapy program for 30 minutes and selected physical therapy program for 30 minutes 3 times per week for 3 months (total session: 1 hour). |
| The study group 2 | Experimental | Device: transcutaneous electrical nerve stimulation (TENS), Other: selected physical therapy program15 patients: receiving 36 sessions of TENS program for 30 minutes and selected physical therapy program for 30 minutes 3 times per week for 3 months (total session: 1 hour). |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Duration of illness not less than six months post-stroke (Hillis A. et al., 2006).
- Patients' age ranges from forty-five to sixty-five years (Feigin et al., 2022).
- Body mass index from (18.5 to 24.9).
- Patients can respond to verbal instructions (Consciousness and orientation to time, place, and person) more than 13 degrees on the Glasco coma scale (Hegazy et al., 2020).
- Able to walk independently on an even surface without any assistive device (Fan and Yin, 2013).
Key exclusion criteria (9 listed)
- Subjects with any other Co-existing Progressive neurological disorder (Hegazy et al., 2020).
- Unstable Cardiac condition (E.g., Acute Myocardial infarction, severe Cardiac Failure) (Teslim et al., 2013).
- Subjects with any anti-spastic Drugs (Chang et al., 2013).
- Musculoskeletal disorders affecting gait kinematics such as severe arthritis, knee surgery, and total hip joint replacement, lower limb fractures less than 6 months or contractures of fixed deformity, leg length discrepancy.
- Any previous Contracture or deformities (Hegazy et al., 2020).
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 |
|---|---|---|
| high tone power therapysessions are applied for 30 minutes, 3 times per week, for 3 months | Device | The study group1 |
| transcutaneous electrical nerve stimulation (TENS)sessions are applied for 30 minutes, 3 times per week, for 3 months | Device | The study group 2 |
| selected physical therapy programsessions are applied for 1 hour, 3 times per week, for 3 months in form o fstretching exercise , range of motion exercises , conventional gait training progressive resistance exercises | Other | The control group, The study group 2, The study group1 |
Primary outcome
Modified Ashworth Scale (MAS)
Time frame: measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention
This scale is used to measure spasticity of Calf muscle in grades from 0 to 5.
Computerized electromyography (EMG) using H/M ratio
Time frame: measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention
EMG is an objective device used to measure spasticity of the Soleus muscle in percentage (%)
Ten-meter Walk test(10-MWT)
Time frame: measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention
This scale is used to measure walking speed in m/s * self-selected walking speed (SSWS) in (m/s). * fastest walking speed (FWS) in (m/s).
Time up and go test (TUG)
Time frame: measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention
This test is used to measure time taken by patient to apply sit to stand, walk a distance of 3 meters, turn and walk back to the chair in (sec.)
Gait velocity
Time frame: measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention
Gait Analyzer Smart Phone Application is an objective tool that assesses gait velocity (m/s).
cadence
Time frame: measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention
Gait Analyzer Smart Phone Application is an objective tool that assesses cadence: the number of steps per second in (steps/ s).
step time
Time frame: measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention
Gait Analyzer Smart Phone Application is an objective tool that assesses step time in ( msec.)
step time symmetry
Time frame: measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention
Gait Analyzer Smart Phone Application is an objective tool that assesses step time symmetry: the symmetry in time between affected and unaffected lower limbs in percentage (%)
step length
Time frame: measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention
Gait Analyzer Smart Phone Application is an objective tool that assesses step length by the inertial sensor system symmetry in meters (m).
step length symmetry
Time frame: measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention
Gait Analyzer Smart Phone Application is an objective tool that assesses step length symmetry: the symmetry in step length between affected and unaffected lower limbs in percentage (%)
1 secondary outcome
Lafayette Hand-held Dynamometer
Time frame: measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Derived from this study: PubMed 41721793Mahmoud JM, Fayez ES, Ahmed S, Gelany FM, Hassan IM, El-Zanaty MY. Impact of High Tone Power Therapy on Lower Limb Spasticity and Gait Speed in Patients at Least Six Months Post-Stroke: A Randomized Controlled Trial. Physiother Res Int. 2026 Apr;31(2):e70175. doi: 10.1002/pri.70175.
- Individual participant dataSharing planned: No
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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.
Eman S Fayiz, Professor study chair
Cairo University
Mahmoud Y El-Zanaty study chair
Cairo University
Sandraa M Ahmed, Professor study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high tone power therapy, transcutaneous electrical nerve stimulation (TENS) and selected physical therapy program in people with Stroke, 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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 23 Aug 2024. 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. 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?
Results are not available in the source record.
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?
Modified Ashworth Scale (MAS) (time frame: measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06562530, which also lists 1 linked publication.
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 23 Aug 2024.