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NCT Number: NCT07309081

Effect of Soleus Muscle Kinetic Control Training on Gait and Electromyographic Activity in Patients With Stroke

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

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

45 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

soleus kinetic control

Other

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 Therapy

Other

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

Primary outcomes

  1. 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

  2. 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

  3. Gait Cycle time

    Time frame: up to eight weeks

    time of gait cycle (seconds) will be measured by steady device

  4. step time

    Time frame: up to eight weeks

    the time of step by seconds will be measured by steady device

  5. cadence

    Time frame: up to eight weeks

    Cadence, number of steps per minute, will be measured by steady device

  6. stance phase percentage

    Time frame: up to eight weeks

    the percentage of stance phase will be measured by steady device

  7. swing phase percentage

    Time frame: up to eight weeks

    the percentage of swing phase will be measured by steady device

  8. 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

  9. 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

  10. stride length

    Time frame: up to eight weeks

    stride length by cm will be measured by steady device

  11. gait speed

    Time frame: up to eight weeks

    gait speed by km/h will measured by steady device

Study contacts

Contact information is provided by the study sponsor or research team.

habiba mohamed, master

CONTACT

[email protected]

0 10 90708377

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Acronym: EMG

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 30, 2025
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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