StrokeEMGNCT07309081
Effect of Soleus Muscle Kinetic Control Training on Gait and Electromyographic Activity in Patients With Stroke
A study testing conventional therapy in people with Stroke, run by Cairo University.
Trial summary
this study was designed to investigate the effect of soleus muscle kinetic control training on Gait and electromyographic activity of the calf muscle in patients with stroke Read more about this study
- Who is it for?
- Ages 45 to 60 years
- Conditions the study is for
- Stroke
- What is being tested?
- conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2025to 15 Jun 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 45 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ischemic or hemorrhagic stroke, as confirmed by CT and or MRI scan.
- Age of the patients between 45 to 60 years old.
- Ability to walk a minimum of 10 m with or without some physical assistance from a therapist (functional ambulation category more than 2).
- Demonstrate weakness of the foot muscles, measured by muscle function tests according Medical Research council scale more than 3.
- Muscle tone of the affected lower limb ranges from 1 to +1 according to modified Ashworth scale.
Who cannot join
- Unilateral neglect, hemianopia, or apraxia
- Having any other neurological disorder affecting their lower extremities e.g. MS, Parkinsonism, peripheral neuropathy.
- Patients with previous fractures in lower limb (Ankle or foot).
- Patients with musculoskeletal disorder such as severe arthritis, ankle surgery, leg length discrepancy or contractures of fixed deformity of ankle joint.
- Patients with visual, auditory impairment affecting their ability to complete tasks.
- Patients with cognitive impairments
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
this study was designed to investigate the effect of soleus muscle kinetic control training on Gait and electromyographic activity of the calf muscle in patients with stroke
Read the detailed description
Stroke is a neurological condition characterized by a reduced blood supply to the brain tissue, resulting in paralysis of part or all of the body, limiting physical activity and social participation. Gait impairment accounts for the largest proportion of physical activity limitations in stroke patients and is characterized by muscle weakness, foot drop, spasticity, and foot deformity .Gait abnormalities following stroke are often disabling. Reduced ankle dorsiflexion, knee flexion, or hip flexion torques are often postulated causes of compromised toe clearing during the swing phase of gait. conversely, gait asymmetry and reduced walking speed has been attributed to weakness of the planter flexors.The kinetic control comprises balanced presentation of the movement choices with ideal interaction among the key components for the sensorimotor neuromuscular control that mediated by afferent sensory input, particularly the proprioceptive input, CNS integration, optimal motor co-ordination, and physiological stresses to assure functional dynamic stability and controlled mobility. forty patients with stroke will be assigned to two groups; one group will recieve kinetic control plus conventional therapy and control group will receive conventinoal therapy alone.
- Conditions
- Stroke
- Being tested
- soleus kinetic control, conventional therapy
- Keywords
- kinetic control, gait, EMG, stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
soleus kinetic controlOther
patients will receive kinetic control for 30 minutes structural progressive training for the soleus muscle guided by the EMG biofeedback plus conventional therapy; 1)Start in crook lying position with the heels level with the pelvis and lift the pelvis clear of the floor followed by bilateral heel raise,2)Progress further by shifting weight onto one leg and holding the heel raise and slowly lowering eccentrically on 1 foot, the next progression is to perform the same movement with the heels lower than the pelvis on step -below the pelvis. The exercise graduation will be guided by the visual EMG Biofeedback participants will receive feedback on soleus activation throughout the training.
conventional therapyOther
the patients will receives conventional physiotherapy program static stretching and stretching board for calf muscle, stretching board, and push off exercises by having the patient push against the therapist or a treatment table during forward gait ( 30 minute), static stretch(30sec\set , rest 20sec\set total 5 set, 3 times \week , for 8 week ), stretching board (4 min\set , rest 1 min\set total 2 set , 3 times \week , for 8 week ) (10 minute) push off training (15 minute 3 times \week , for 8 week )x2
| Study group | Role | What they receive |
|---|---|---|
| soleus kinetic control | Experimental | twenty patients will receive soleus kinetic control plus conventional physiotherapy three times a week for 8 weeks Receives: Other: soleus kinetic control; Other: conventional therapy |
| conventional therapy | Active comparator | twenty patients will receive conventional physiotherapy three times a week for 8 weeks Receives: Other: conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle amplitude
A steady device will be used to assess muscle amplitude in the form of RMS with microvolt as the measurement unit
Measured: up to eight weeks
giat function
The Dynamic Gait Index (DGI) is an ordinal test of gait function evaluates the capacity to adapt gait to complex walking tasks encountered in everyday life. Eight aspects of gait are scored based on observation as the patient walks over a 6.1-m level surface.
The rater records an ordinal score that ranges from 0 (unable or done very poorly) to 3 (normal score) for a total point value of 24. Scores of less than 21 appear to suggest risk for falls
Measured: up to eight weeks
Gait Cycle time
time of gait cycle (seconds) will be measured by steady device
Measured: up to eight weeks
step time
the time of step by seconds will be measured by steady device
Measured: up to eight weeks
cadence
Cadence, number of steps per minute, will be measured by steady device
Measured: up to eight weeks
stance phase percentage
the percentage of stance phase will be measured by steady device
Measured: up to eight weeks
swing phase percentage
the percentage of swing phase will be measured by steady device
Measured: up to eight weeks
single and double support percentage
single and double support percentage of gait cycle will be measured by steady device
Measured: up to eight weeks
first and second double support percentage
first and second double support percentage of gait cycle will be measured by steady devcie
Measured: up to eight weeks
stride length
stride length by cm will be measured by steady device
Measured: up to eight weeks
gait speed
gait speed by km/h will measured by steady device
Measured: up to eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start15 Dec 2025 (estimated)
- Primary completion15 Jun 2026 (estimated)
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- kinetic and traditional therapy
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Habiba Mohamed Ahmed Mahmoud, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07309081
- Sponsor's protocol ID
- P.T.REC/012/006089
- Acronym
- EMG
- Status last verified
- Dec 2025
- First submitted
- 1 Dec 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Soleus Muscle Kinetic Control Training on Gait and Electromyographic Activity in Patients With Stroke
- ClinicalTrials.gov ID
- NCT07309081
- Acronym / sponsor ID
- EMG / P.T.REC/012/006089
- Conditions
- Stroke
- Keywords
- kinetic control, gait, EMG, stroke
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 30 Dec 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 was designed to investigate the effect of soleus muscle kinetic control training on Gait and electromyographic activity of the calf muscle in patients with stroke
Detailed description
Stroke is a neurological condition characterized by a reduced blood supply to the brain tissue, resulting in paralysis of part or all of the body, limiting physical activity and social participation. Gait impairment accounts for the largest proportion of physical activity limitations in stroke patients and is characterized by muscle weakness, foot drop, spasticity, and foot deformity .Gait abnormalities following stroke are often disabling. Reduced ankle dorsiflexion, knee flexion, or hip flexion torques are often postulated causes of compromised toe clearing during the swing phase of gait. conversely, gait asymmetry and reduced walking speed has been attributed to weakness of the planter flexors.The kinetic control comprises balanced presentation of the movement choices with ideal interaction among the key components for the sensorimotor neuromuscular control that mediated by afferent sensory input, particularly the proprioceptive input, CNS integration, optimal motor co-ordination, and physiological stresses to assure functional dynamic stability and controlled mobility. forty patients with stroke will be assigned to two groups; one group will recieve kinetic control plus conventional therapy and control group will receive conventinoal therapy alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- kinetic and traditional therapy
| Arm | Type | Receives |
|---|---|---|
| soleus kinetic control | Experimental | Other: soleus kinetic control, Other: conventional therapytwenty patients will receive soleus kinetic control plus conventional physiotherapy three times a week for 8 weeks |
| conventional therapy | Active comparator | Other: conventional therapytwenty patients will receive conventional physiotherapy three times a week for 8 weeks |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Ischemic or hemorrhagic stroke, as confirmed by CT and or MRI scan.
- Age of the patients between 45 to 60 years old.
- Ability to walk a minimum of 10 m with or without some physical assistance from a therapist (functional ambulation category more than 2).
- Demonstrate weakness of the foot muscles, measured by muscle function tests according Medical Research council scale more than 3.
- Muscle tone of the affected lower limb ranges from 1 to +1 according to modified Ashworth scale.
Key exclusion criteria (6 listed)
- Unilateral neglect, hemianopia, or apraxia
- Having any other neurological disorder affecting their lower extremities e.g. MS, Parkinsonism, peripheral neuropathy.
- Patients with previous fractures in lower limb (Ankle or foot).
- Patients with musculoskeletal disorder such as severe arthritis, ankle surgery, leg length discrepancy or contractures of fixed deformity of ankle joint.
- Patients with visual, auditory impairment affecting their ability to complete tasks.
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 |
|---|---|---|
| soleus kinetic controlpatients will receive kinetic control for 30 minutes structural progressive training for the soleus muscle guided by the EMG biofeedback plus conventional therapy; 1)Start in crook lying position with the heels level with the pelvis and lift the pelvis clear of the floor followed by bilateral heel raise,2)Progress further by shifting weight onto one leg and holding the heel raise and slowly lowering eccentrically on 1 foot, the next progression is to perform the same movement with the heels lower than the pelvis on step -below the pelvis. The exercise graduation will be guided by the visual EMG Biofeedback participants will receive feedback on soleus activation throughout the training. | Other | soleus kinetic control |
| conventional therapythe patients will receives conventional physiotherapy program static stretching and stretching board for calf muscle, stretching board, and push off exercises by having the patient push against the therapist or a treatment table during forward gait ( 30 minute), static stretch(30sec\set , rest 20sec\set total 5 set, 3 times \week , for 8 week ), stretching board (4 min\set , rest 1 min\set total 2 set , 3 times \week , for 8 week ) (10 minute) push off training (15 minute 3 times \week , for 8 week )x2 | Other | conventional therapy, soleus kinetic control |
Primary outcome
muscle amplitude
Time frame: up to eight weeks
A steady device will be used to assess muscle amplitude in the form of RMS with microvolt as the measurement unit
giat function
Time frame: up to eight weeks
The Dynamic Gait Index (DGI) is an ordinal test of gait function evaluates the capacity to adapt gait to complex walking tasks encountered in everyday life. Eight aspects of gait are scored based on observation as the patient walks over a 6.1-m level surface. The rater records an ordinal score that ranges from 0 (unable or done very poorly) to 3 (normal score) for a total point value of 24. Scores of less than 21 appear to suggest risk for falls
Gait Cycle time
Time frame: up to eight weeks
time of gait cycle (seconds) will be measured by steady device
step time
Time frame: up to eight weeks
the time of step by seconds will be measured by steady device
cadence
Time frame: up to eight weeks
Cadence, number of steps per minute, will be measured by steady device
stance phase percentage
Time frame: up to eight weeks
the percentage of stance phase will be measured by steady device
swing phase percentage
Time frame: up to eight weeks
the percentage of swing phase will be measured by steady device
single and double support percentage
Time frame: up to eight weeks
single and double support percentage of gait cycle will be measured by steady device
first and second double support percentage
Time frame: up to eight weeks
first and second double support percentage of gait cycle will be measured by steady devcie
stride length
Time frame: up to eight weeks
stride length by cm will be measured by steady device
gait speed
Time frame: up to eight weeks
gait speed by km/h will measured by steady device
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 30 Dec 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing conventional therapy in people with Stroke, run by Cairo University.
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 6 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 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
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 habiba mohamed, master (0 10 90708377, dochabiba4@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
muscle amplitude (time frame: up to eight weeks). The study lists 11 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 30 Dec 2025.