Neuro: Cerebrovascular AccidentNCT07889921
TECAR and FES for Hand Function in Post-Stroke Spasticity
A study testing FES therapy and TECAR therapy and FES in people with Neuro: Cerebrovascular Accident, run by October 6 University at 1 site in Jordan.
Trial summary
Upper-limb spasticity and impaired hand function are experienced by up to 70% of stroke survivors, which significantly restricts their independence in fulfilling daily activities. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Neuro: Cerebrovascular Accident
- What is being tested?
- FES therapy and TECAR therapy and FES
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteJordan
- Study dates
- 20 Jun 2026to 20 Aug 2026
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- chronic stroke survivors (≥ 6 months post-stroke)
- age 40-60
- upper limb hemiparesis with presence of flexor synergy pattern (Brunnstrom Stage 2-4)
- Modified Ashworth Scale (MAS) score of 1-3 for wrist and finger flexors
- Montreal Cognitive Assessment (MoCA) score ≥ 21
Who cannot join
- severe spasticity of wrist muscles (MAS > 3);
- clinical evidence of shoulder subluxation (≥ one finger width)
- botulinum toxin or antispastic medication treatment within 3 months before the study
- any contraindication to TECAR or FES therapy: pacemaker or implanted electronic devices, osteosynthetic material, skin infections or dermatitis in the treatment area, inflammatory vascular diseases, acute inflammation, cancer
- history of epilepsy or recent convulsions
- previous history of wrist problems (arthritis, previous hemiplegia)
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- pregnancy
- active reflex sympathetic dystrophy
- co-morbid neurological disease (spinal cord injury, traumatic brain injury, multiple sclerosis, Parkinson's disease).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Combination of TECAR and Functional Electrical Stimulation on Hand Function in Spastic Upper Limb Stroke Patients: A Randomized Controlled Trial
Upper-limb spasticity and impaired hand function are experienced by up to 70% of stroke survivors, which significantly restricts their independence in fulfilling daily activities. This research aims to assess whether combining TECAR therapy with FES produces superior improvements in hand function compared to FES alone in stroke patients with upper-limb spasticity.
Read the detailed description
Even though both FES and TECAR therapy have been demonstrated to be effective on their own, no studies have investigated the potential synergistic effects of combining these modalities for upper limb rehabilitation in stroke patients. FES addresses the neurological component of motor impairment by promoting neuroplasticity and facilitating functional movements. TECAR, in contrast, targets the biomechanical component by improving tissue viscoelasticity, decreasing spasticity, and increasing blood flow to afflicted muscles and tendons. The justification for combining these therapies is quite compelling. It is possible that this combination could alleviate post-stroke motor impairment by addressing both neural and peripheral components.
So, this research aimed to assess whether the combination of TECAR therapy and FES produces superior improvements in hand function, spasticity reduction, and functional independence compared to FES alone in chronic stroke survivors with upper limb spasticity and flexor synergy.
- Conditions
- Neuro: Cerebrovascular Accident
- Being tested
- FES therapy, TECAR therapy and FES
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FES therapyDevice
FES device (MegaXP FES Machine, South Korea). Two bipolar surface electrodes (active and indifferent, diameter 1.5 inches) were placed over the wrist and finger extensors: Extensor Carpi Radialis Longus (ECRL), Extensor Carpi Radialis Brevis (ECRB), and Extensor Digitorum Communis (EDC). Electrodes were positioned to achieve balanced wrist extension without excessive radial or ulnar deviation.
TECAR therapy and FESDevice
The protocol started with TECAR in the resistive mode (110-140 W, 5 minutes) on the wrist and finger extensor muscles with slow, circular movements combined with functional massage. We continued with TECAR in the capacitive mode in the same region (180-200 VA, 4 minutes) with gentle gliding movements. We ended the TECAR session with the resistive mode on the dorsal hand, wrist joint, and finger extensor tendons (100-120 W, 3 minutes) with focal application on specific tendinous and joint structures
| Study group | Role | What they receive |
|---|---|---|
| FES group | Experimental | administrated FES therapy in addition to standard rehabilitation Receives: Device: FES therapy |
| Combined group | Experimental | received a combination of TECAR therapy and FES in addition to standard rehabilitation Receives: Device: FES therapy; Device: TECAR therapy and FES |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Modified Ashworth Scale
a 6-point clinical tool used to measure increased muscle tone (hypertonia) and resistance to passive movement in patients with central nervous system conditions.
Scoring: grade 0 (normal), grade 1 and 1+ (mild spasticity), grade 2 and 3 (moderate spasticity), grade 4 (severe spasticity)
Measured: one month
Action Research Arm Test
a 19-item observational measure used by clinicians to evaluate upper-extremity coordination, dexterity, and functional performance in patients with neurological conditions such as stroke, traumatic brain injury (TBI), or multiple sclerosis. A 4-point rating system is used to evaluate task performance, with 0 representing no movement and 3 representing normal movement
Measured: one month
Secondary outcomes (3)
The upper extremity Fugl-Meyer Assessment
A 3-point ordinal scale, with 0 representing "cannot perform," 1 representing "performs partially," and 2 representing "performs fully," is used to rate scale items based on the ability to complete them. 226 is the maximum possible score on the scale.
Measured: one month
Functional Independence Measure (FIM) self-care component
Self-care independence, sphincter control, transfers, mobility, communication, and social cognition are all evaluated. The degree of assistance needed determines the functional status, which ranges from entire assistance to complete independence. Higher scores indicate greater independence. The total score falls between 18 and 126.
Measured: one month
Surface electromyography (sEMG)
a safe, non-invasive technique that records the electrical activity of skeletal muscles using electrodes placed directly on the skin.
Measurements: evaluate activation of extensor carpi radialis (ECR) and extensor digitorum communis (EDC).
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start20 Jun 2026
- Primary completion20 Jul 2026
- Study completion20 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuro: Cerebrovascular AccidentStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hosam Magdy Metwally, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07889921
- Sponsor's protocol ID
- 10556
- Status last verified
- Oct 2026
- First submitted
- 10 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Combination of TECAR and Functional Electrical Stimulation on Hand Function in Spastic Upper Limb Stroke Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07889921
- Acronym / sponsor ID
- 10556
- Conditions
- Neuro: Cerebrovascular Accident
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 20 Jun 2026 (actual)
- Primary completion
- 20 Jul 2026 (actual)
- Study completion
- 20 Aug 2026 (actual)
- First posted
- 22 Oct 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.
Upper-limb spasticity and impaired hand function are experienced by up to 70% of stroke survivors, which significantly restricts their independence in fulfilling daily activities. This research aims to assess whether combining TECAR therapy with FES produces superior improvements in hand function compared to FES alone in stroke patients with upper-limb spasticity.
Detailed description
Even though both FES and TECAR therapy have been demonstrated to be effective on their own, no studies have investigated the potential synergistic effects of combining these modalities for upper limb rehabilitation in stroke patients. FES addresses the neurological component of motor impairment by promoting neuroplasticity and facilitating functional movements. TECAR, in contrast, targets the biomechanical component by improving tissue viscoelasticity, decreasing spasticity, and increasing blood flow to afflicted muscles and tendons. The justification for combining these therapies is quite compelling. It is possible that this combination could alleviate post-stroke motor impairment by addressing both neural and peripheral components.
So, this research aimed to assess whether the combination of TECAR therapy and FES produces superior improvements in hand function, spasticity reduction, and functional independence compared to FES alone in chronic stroke survivors with upper limb spasticity and flexor synergy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FES group | Experimental | Device: FES therapyadministrated FES therapy in addition to standard rehabilitation |
| Combined group | Experimental | Device: FES therapy, Device: TECAR therapy and FESreceived a combination of TECAR therapy and FES in addition to standard rehabilitation |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- chronic stroke survivors (≥ 6 months post-stroke)
- age 40-60
- upper limb hemiparesis with presence of flexor synergy pattern (Brunnstrom Stage 2-4)
- Modified Ashworth Scale (MAS) score of 1-3 for wrist and finger flexors
- Montreal Cognitive Assessment (MoCA) score ≥ 21
Key exclusion criteria (9 listed)
- severe spasticity of wrist muscles (MAS > 3);
- clinical evidence of shoulder subluxation (≥ one finger width)
- botulinum toxin or antispastic medication treatment within 3 months before the study
- any contraindication to TECAR or FES therapy: pacemaker or implanted electronic devices, osteosynthetic material, skin infections or dermatitis in the treatment area, inflammatory vascular diseases, acute inflammation, cancer
- history of epilepsy or recent convulsions
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 |
|---|---|---|
| FES therapyFES device (MegaXP FES Machine, South Korea). Two bipolar surface electrodes (active and indifferent, diameter 1.5 inches) were placed over the wrist and finger extensors: Extensor Carpi Radialis Longus (ECRL), Extensor Carpi Radialis Brevis (ECRB), and Extensor Digitorum Communis (EDC). Electrodes were positioned to achieve balanced wrist extension without excessive radial or ulnar deviation. | Device | Combined group, FES group |
| TECAR therapy and FESThe protocol started with TECAR in the resistive mode (110-140 W, 5 minutes) on the wrist and finger extensor muscles with slow, circular movements combined with functional massage. We continued with TECAR in the capacitive mode in the same region (180-200 VA, 4 minutes) with gentle gliding movements. We ended the TECAR session with the resistive mode on the dorsal hand, wrist joint, and finger extensor tendons (100-120 W, 3 minutes) with focal application on specific tendinous and joint structures | Device | Combined group |
Primary outcome
The Modified Ashworth Scale
Time frame: one month
a 6-point clinical tool used to measure increased muscle tone (hypertonia) and resistance to passive movement in patients with central nervous system conditions. Scoring: grade 0 (normal), grade 1 and 1+ (mild spasticity), grade 2 and 3 (moderate spasticity), grade 4 (severe spasticity)
Action Research Arm Test
Time frame: one month
a 19-item observational measure used by clinicians to evaluate upper-extremity coordination, dexterity, and functional performance in patients with neurological conditions such as stroke, traumatic brain injury (TBI), or multiple sclerosis. A 4-point rating system is used to evaluate task performance, with 0 representing no movement and 3 representing normal movement
3 secondary outcomes
The upper extremity Fugl-Meyer Assessment
Time frame: one month
Functional Independence Measure (FIM) self-care component
Time frame: one month
Surface electromyography (sEMG)
Time frame: one month
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 22 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FES therapy and TECAR therapy and FES in people with Neuro: Cerebrovascular Accident, run by October 6 University at 1 site in Jordan.
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 5 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: finished, as of the sponsor's last update on 22 Oct 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 Jordan. 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?
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?
The Modified Ashworth Scale (time frame: one month). The study lists 2 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 22 Oct 2026.